Kendall et al.

Chiropractic & Manual Therapies (2018) 26:14

https://doi.org/10.1186/s12998-018-0183-1

RESEARCH Open Access

Chiropractic treatment including

instrument-assisted manipulation for
non-specific dizziness and neck pain in
community-dwelling older people: a
feasibility randomised sham-controlled trial
Julie C. Kendall1, Simon D. French2,3, Jan Hartvigsen4,5 and Michael F. Azari1*

Abstract
Background: Dizziness in older people is a risk factor for falls. Neck pain is associated with dizziness and responds
favourably to neck manipulation. However, it is unknown if chiropractic intervention including instrument-assisted
manipulation of the neck in older people with neck pain can also improve dizziness.
Methods: This parallel two-arm pilot trial was conducted in Melbourne, Australia over nine months (October 2015 to June
2016). Participants aged 65–85 years, with self-reported chronic neck pain and dizziness, were recruited from the general
public through advertisements in local community newspapers and via Facebook. Participants were randomised using a
permuted block method to one of two groups: 1) Activator II™-instrument-assisted cervical and thoracic spine manipulation
plus a combination of: light massage; mobilisation; range of motion exercises; and home advice about the application of
heat, or 2) Sham-Activator II™-instrument-assisted manipulation (set to zero impulse) plus gentle touch of cervical and
thoracic spinal regions. Participants were blinded to group allocation. The interventions were delivered weekly for four
weeks. Assessments were conducted one week pre- and post-intervention. Clinical outcomes were assessed blindly and
included: dizziness (dizziness handicap inventory [DHI]); neck pain (neck disability index [NDI]); self-reported concerns of
falling; mood; physical function; and treatment satisfaction. Feasibility outcomes included recruitment rates, compliance with
intervention and outcome assessment, study location, success of blinding, costs and harms.
Results: Out of 162 enquiries, 24 participants were screened as eligible and randomised to either the chiropractic (n = 13)
or sham (n = 11) intervention group. Compliance was satisfactory with only two participants lost to follow up; thus, post-
intervention data for 12 chiropractic intervention and 10 sham intervention participants were analysed. Blinding was
similar between groups. Mild harms of increased spinal pain or headaches were reported by 6 participants. Costs
amounted to AUD$2635 per participant. The data showed a trend favouring the chiropractic group in terms of clinically-
significant improvements in both NDI and DHI scores. Sample sizes of n = 150 or n = 222 for dizziness or neck pain
disability as the primary outcome measure, respectively, would be needed for a fully powered trial.
Conclusions: Recruitment of participants in this setting was difficult and expensive. However, a larger trial may be
feasible at a specialised dizziness clinic within a rehabilitation setting. Compliance was acceptable and the outcome
measures used were well accepted and responsive.
(Continued on next page)

* Correspondence: [email protected]
1
School of Health and Biomedical Sciences, RMIT University, PO Box 71
Bundoora, Melbourne, VIC 3083, Australia
Full list of author information is available at the end of the article

© The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Kendall et al. Chiropractic & Manual Therapies (2018) 26:14 Page 2 of 11

(Continued from previous page)

Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12613000653763. Registered 13 June 2013.
Trial funding: Foundation for Chiropractic Research and Postgraduate Education (Denmark).
Keywords: Neck pain, Dizziness, Elderly, Chiropractic, Randomised controlled trial

Background been shown to reduce neck pain in adults in general [27]

Dizziness and musculoskeletal pain are common in older and in older people specifically [28]. Furthermore, there
people [1–4] and are associated with postural instability have been small studies reporting positive effects of man-
[5], fear of falling [6–8], and increased incidence of falls ual therapy in improving dizziness and musculoskeletal
[9–12]. Among Australian adults, 36% of people aged pain in older people [29–31]. In fact, there is evidence that
over 50 years report the presence of dizziness within the dizziness specifically associated with neck pain in adults
last month [13]. Similarly, the prevalence of neck pain in may be attenuated with manual therapy, including SMT
Australian older adults has been estimated at 36% and [32, 33]. However, previous studies have several important
41% for men and women respectively [14], and in older limitations including: lack of specific examination of neck
adults, 5% of men and 8% of women report that neck pain [29–31]; lack of a control group [29, 30, 34]; use of a
pain interferes with their physical activity [2]. ‘no treatment’ control group [31], issues with appropriate
Dizziness is a known risk factor for falls in community- outcome measures [35] and small sample sizes. SMT can
dwelling older people [11], and dizziness is not optimally be performed manually or assisted through an instrument.
managed at present. One in three older people with dizzi- There is some evidence suggesting that low-force Activa-
ness are prescribed medications that are known to in- tor™-instrument-assisted manipulation may produce ef-
crease the risk of falling including: anti-hypertensives; fects on musculoskeletal pain that are comparable to
anxiolytics and antidepressants; nitrates; analgesics; and those of manual SMT [36]. Even though reported signifi-
anti-vertigo medications [15]. Anti-vertigo medications in cant harms following neck SMT in older people are rare
particular, are commonly prescribed for non-vestibular [37], due to increased risk of osteoporosis in this popula-
causes of dizziness [16]. Therefore, there is a need to de- tion, low-force SMT techniques are recommended by re-
velop and validate non-pharmacological treatment strat- cent chiropractic guidelines [38].
egies for dizziness in this population, which in turn may A feasibility or pilot study is generally recommended be-
reduce the need for prescription of pharmacological fore a Phase III clinical trial [39]. Feasibility studies can
agents with their attendant potential side-effects [15, 17]. determine the efficiency of recruitment strategies, ad-
Neck pain may increase the risk of falls in the elderly. equacy of randomisation and blinding, appropriateness of
Sensory information from various structures including the outcome measures, and acceptability of compliance levels,
vestibular apparatus in the inner ear, the eyes, and the pro- as well as give some indication of the frequency and na-
prioceptive receptors in muscles and joints, particularly of ture of harms. In this way, it is possible to ensure that the
the neck, is integrated by the brain for position sense, bal- full-scale trial makes efficient use of resources, and is suffi-
ance and motor control [18]. In some individuals, neck pain ciently powered to provide meaningful results [40].
is linked with dizziness, in a syndrome termed ‘cervicogenic We conducted a feasibility randomised sham-controlled
dizziness’ or ‘cervical dizziness’ [19–21]. There are reports trial (RCT) of a chiropractic intervention including
in neck pain patients of a correlation between cervical joint instrument-assisted SMT in older people with chronic diz-
stiffness and hypertonicity of the upper cervical muscula- ziness and concomitant chronic neck pain. The primary ob-
ture and the presence of dizziness [22–24]. There are many jective of this trial was to test the feasibility of a fully-
different causes of dizziness in older people, including ves- powered RCT, based on recruitment rates, compliance with
tibular, cardiovascular, and psychological [25]. In addition, intervention and outcome assessment, study location, suc-
since cervicogenic dizziness is a diagnosis of exclusion, its cess of blinding, costs and harms. The secondary objective
exact incidence and prevalence remain unknown and a de- of this trial was to calculate, based on observed group dif-
finitive diagnosis of cervicogenic dizziness is not possible in ferences, sample sizes for fully-powered RCTs using the
primary care settings. Therefore, this study recruited older dizziness handicap inventory (DHI) or neck disability index
people who reported both chronic non-specific dizziness (NDI) as the primary outcome measures.
and chronic neck pain to optimise the relevance of the
study findings for primary care settings. Methods
Spinal manipulative therapy (SMT) is widely used by Study design
chiropractors, osteopaths and physiotherapists, for muscu- We conducted a parallel two-arm, randomised, sham-
loskeletal conditions, including neck pain [26]. SMT has controlled feasibility trial. Participants were allocated to
Kendall et al. Chiropractic & Manual Therapies (2018) 26:14 Page 3 of 11

either a chiropractic intervention or sham intervention Chiropractic intervention

using a block randomisation procedure. Chiropractic care included: Activator II™ instrument-assisted
manipulation plus one or more of the following: joint mobil-
Ethics and trial registration isation; massage; range of motion neck exercises; or advice
The human ethics clearance was obtained from RMIT to apply heat at home. Interventions were directed to cer-
University’s human research ethics committee (HREC) vical and thoracic joints that displayed local tenderness and/
(Approval number 29/13). The trial was registered in the or areas of joint stiffness in accordance with common chiro-
Australian New Zealand Clinical Trials Registry (ANZCTR) practic practice [42]. The chiropractor administered the
(Registration number: ACTRN12613000653763). instrument-delivered thrust following pre-tensioning of
hypo-mobile cervical joints in lateral flexion without extend-
Participants ing or rotating the neck [43]. Instrument-assisted manipula-
Recruitment tions to the thoracic spine were delivered in the prone
Participants were recruited from the northern Melbourne position. Manipulation with or without mobilisation was
metropolitan region via notices in ‘The Leader’ local newspa- supplemented with massage to hypertonic muscles of the
pers (covering Diamond Valley, Hume, Whittlesea, and cervical and thoracic spine, as determined by the clinical
Moreland municipal areas), flyers at local community centres judgment of the practitioner, as well as advice on local appli-
surrounding the research location, flyers at RMIT university cation of heat at home. Massage consisted of a combination
departments, and targeted online Facebook advertisements. of effleurage, and ischaemic compression techniques. The
Potential participants who responded to these recruitment intervention approach was designed to reflect actual contem-
methods were interviewed over the telephone to determine porary Australian chiropractic care (unpublished data) and
eligibility for study enrolment. If eligibility could not be recent chiropractic practice guidelines [38].
determined via telephone alone, potential participants were
invited to the university campus for further examination by a
Sham intervention
research assistant, who was a registered chiropractor.
Activator II™ instrument impulses (set at zero) and gentle
placement of the practitioner’s hands on the cervical and
Inclusion criteria
thoracic spine regions. This was a modification of a published
Participants included in the study were men and women
sham procedure [44]. No massage, mobilisation, or home ad-
aged between 65 and 85 years. Participants had to report
vice was given to the participants in the sham group.
having neck pain with concomitant dizziness (described
as dizziness or unsteadiness), at least of three-months
duration each. Pain and dizziness could be constant or Outcome measures
intermittent within the previous three months. Feasibility outcome measures
Feasibility of running a larger trial was determined based
Exclusion criteria on recruitment rates, compliance with intervention and
Participants were excluded if they self-reported: diag- outcome assessment, reviewing the study location, blind-
nosed vestibular pathology such as Meniere’s disease or ing, costs and reporting of harms.
benign paroxysmal positional vertigo; a history of cere-
brovascular accident or myocardial infarct; psychiatric
Recruitment rate
disease; active inflammatory spondyloarthropathies (e.g.
The recruitment rate was determined by comparing the
rheumatoid arthritis, psoriatic arthritis, ankylosing spon-
number of enquiries from each advertising method with
dylitis); recent spinal trauma; osteomyelitis; spinal tu-
the number of participants who were enrolled from each
mours; acute myelopathy; and if they had received neck
of those methods. Additionally, the inclusion and exclu-
any SMT or neck massage during the previous three
sion criteria were reviewed by examining the frequency
months. Participants were excluded if they showed signs
and the reasons for exclusion during screening.
of cognitive impairment as demonstrated by a Montreal
Cognitive Assessment (MoCA) score of 20 or less [41].
Compliance
Interventions Participants’ compliance with the outcome assessment
All interventions, including the sham intervention, were de- was examined by noting the time taken to complete the
livered by either one of two registered practicing chiroprac- baseline questionnaires and assessments, and reviewing
tors (depending on availability) who each had at least if any outcome measures were consistently filled out in-
20 years of clinical experience. Four intervention sessions correctly or were incomplete. Compliance with the inter-
were given over four weeks, and the duration of each vention schedule was examined by measuring drop-out
session was kept to 15 min in both groups. rates and reasons for drop-outs.
Kendall et al. Chiropractic & Manual Therapies (2018) 26:14 Page 4 of 11

Study location Sample size

We determined if participants dropped out, or had diffi- As a feasibility study, this trial did not have an a priori
culty finding the clinical trial centre, due to its location calculated sample size. We aimed for a sample size of 40
on the Bundoora campus of RMIT University. to generate sufficient information to address the feasibil-
ity objectives, particularly the recruitment rate.

Blinding and treatment satisfaction Randomisation

At the conclusion of the follow-up outcome measure assess- Participants were randomly assigned after the baseline
ment, participants indicated which intervention group they appointment using a permuted block randomisation
believed they were in (sham or chiropractic) to determine protocol. The randomisation schedule was conducted by
the integrity of allocation. All participants were also asked to an independent statistician before recruitment using a
rate their satisfaction with treatment on a five-point scale computer generated random list of numbers. This list
(from 1: I feel much worse to 5: I feel much better). was used to assign random blocks of four or six partici-
pants at a time. Group allocations were concealed by
placing them in opaque consecutively numbered sealed
Costs
envelopes, which were opened, in order, by the treating
The feasibility of conducting a larger, fully-powered
chiropractor before the first intervention session.
study was assessed on the basis of the costs of: advertis-
ing, equipment, and hiring the chiropractors and re-
Blinding
search assistants to recruit and screen potential
Participants were blinded to group allocation. The re-
participants and administer the interventions.
searcher performing the outcome assessments was also
blinded to group allocation. The chiropractors involved in
Harms performing the interventions were blinded to the results
Harms were defined as adverse consequences of the inter- of the outcome assessments at pre- and post-intervention.
vention reported by participants. In accordance with the
World Health Organisation’s [45] Conceptual Framework Analysis
for the International Classification for Patient Safety, the Feasibility determination
degree of harm was classified as: none (no symptoms de- A fully powered RCT using this protocol would be
tected and no treatment required), mild (minimal or inter- determined a priori to not be feasible in our setting if:
mediate short term harm caused, and minimal or no
intervention required), moderate (permanent or long-  At least 40 participants could not be recruited
term harm caused, or intervention required), severe within the three-month trial period.
(major permanent or long-term harm caused, or major  More than 20% of all participants could not
surgical/medical or life-saving intervention required) or participate for the following reasons:
death (death caused or brought forward). Harms and i. Primarily identifying travelling to the study
other reactions to interventions were documented by the location as inconvenient;
treating chiropractor at each intervention session. ii. Being unable able to complete all outcome
measure assessments, or unable to complete
them within the allocated two hours;
Clinical outcomes iii. Becoming lost trying to find the study location.
Clinical outcomes were assessed at the baseline visit  More than 15% of participants in either group
(one week pre-intervention) and follow-up visit (one dropped out.
week post-intervention). Dizziness, pain, quality of life,  More than 70% (20% greater than chance) of
mood, and concerns of falling were assessed with self- participants in either group correctly identified their
reported questionnaires. The physical function and mo- allocation at post-intervention follow-up, or blinding
bility assessments were performed one after the other, was significantly different between groups.
and participants were able to take breaks in between if  The average cost of recruitment and intervention
they became tired. During all physical function tasks, the per participant was more than $1500.
investigator stood close by to assist/steady the partici-  There were any reported severe harms.
pant as required. These outcome measures were chosen
to explore potential clinical measures that may show im- A fully-powered RCT was determined to be feasible with
provement of pain and dizziness to be utilised in a larger modifications if any of the above criteria were not satisfied
trial as primary (neck pain or dizziness) or secondary but could be modified in such a way as to preserve the
(quality of life, mood and physical function) outcomes. integrity of the study.
Kendall et al. Chiropractic & Manual Therapies (2018) 26:14 Page 5 of 11

Statistical analysis perform any statistical analysis to determine effectiveness

To address the primary objective of the trial, descriptive of the chiropractic intervention.
statistics were calculated and reported for all feasibility
and clinical outcome measures. Pre- and post- interven-
tion self-reported and test outcomes were calculated for Results
each group with means and standard deviations. A chi- Recruitment
squared test was performed to determine if blinding was A total of 24 participants were recruited from 162 tele-
similar between groups, using IBM SPSS software (version phone enquiries (Fig. 1). The recruitment period ran over
22). To address the secondary objective of the trial, two nine months, from October 2015 to June 2016; six months
sample size calculations for possible larger, fully-powered over the planned three-month period. Most commonly,
trials were conducted at the conclusion of this trial with screened participants were excluded due to the presence
NDI or DHI as the primary outcome measure. Sample size of self-reported diagnosed vestibular and spinal patholo-
was calculated in G*Power (version 3.1.9.2) to estimate an gies (n = 27 [20%]), neck pain without symptoms of dizzi-
a priori two-tailed independent two-group mean differ- ness (n = 19 [14%]), history of cardiovascular incidents (n
ence using the effect size (cohen’s d) estimated from the = 18 [13%]), recent manual therapy (n = 14 [10%]) and not
NDI and DHI data based on means and standard devia- being able to travel to the research site (n = 16 [12%]). Ten
tions of post-intervention scores for each group. Sample participants (7%), who otherwise could have participated,
size was estimated for a power set to 80%, and significance were excluded due to low performance on the MoCA cog-
level of 0.05. Since this was a feasibility study, we did not nitive function assessment.

Fig. 1 Flow of participants through the trial

Kendall et al. Chiropractic & Manual Therapies (2018) 26:14 Page 6 of 11

Using Facebook as a recruitment method for older to AUD$2635 per participant. The costs (per participant)
Australians was surprisingly successful, with 38 (23%) of recruitment and intervention were AUD$2141 and
enquiries; however, it captured many potential partici- AUD$494 respectively. These costs excluded the salary of
pants who were unable to travel to the trial location. the senior author (MFA) and the PhD scholarship of the
The trial was stopped before the target 40 participants first author (JCK).
was reached due to time and budget constraints.
Harms
Compliance Six (27%) participants reported harms. All harms were
Clinical outcome measurements took between 60 and mild, including increased neck pain (chiropractic n = 2,
90 min to complete for most participants, and all partici- sham n = 1), headache (chiropractic n = 1, sham n = 1)
pants took less than the 2 h that was allocated. Partici- and mid-back pain (chiropractic n = 1).
pants were offered a break if they became tired, but this
proved to be unnecessary in all cases. Questionnaires
Clinical outcomes
were checked by the investigator who pointed out sev-
Many clinical outcome measures were used in this study
eral questions that were often missed and asked the par-
(Table 1). Participants had moderate intensity of dizziness
ticipant to complete them.
at baseline [mean (SD)] in both the chiropractic group and
After enrolment in the trial, participant compliance with
the sham group (Table 2). DHI scores were also similar at
the four interventions were deemed acceptable, with only
baseline and improved in both groups post-intervention
two drop-outs. One drop-out from the sham group had a
[chiropractic 28.33 (14.37) to 40.77 (12.48); sham 44.00 (16.
spontaneous aggravation of a lower back complaint unre-
97) to 36.40 (20.11)]. Similarly, NDI scores were reduced
lated to intervention and another participant in the chiro-
post-intervention [chiropractic 24.94 (12.87) to 19.07 (12.
practic intervention group did not start the intervention
50); sham 24.18 (8.22) to 22.8 (6.2)]. Fifty eight percent of
due to inability in making the travel commitment.
the chiropractic group showed a clinically-significant im-
provement (of at least 19%) in NDI scores compared to
Location
30% of the sham group (Table 3). The DHI scores improved
Travel to the outer-suburban university location was a
by the clinically significant amount (of at least 18%) in 67%
barrier for 16 (12%) potential participants. Additionally,
of the chiropractic group compared to 50% of the sham
one drop-out was due to difficulties with travel. Partici-
group. Mood was generally low, with participants com-
pants often became lost on their initial visit to the cam-
monly reporting symptoms of depression, anxiety and
pus. While temporary parking permits were provided,
stress on the DASS. Concerns of falling were high in both
the participants had to pick these up from the security
groups at baseline [chiropractic 26.00 (5.61); sham 29.00 (5.
station. This was sometimes confusing for them.
71)], and reduced slightly in both groups [chiropractic 24.
42 (5.21); sham 26.7 (6.29)]. All participants were able to
Blinding and overall improvement
complete the physical functional tasks.
Blinding was similar between groups, with 5 (50%) par-
ticipants in the sham group and 8 (67%) participants in
the chiropractic group correctly identifying which inter- Sample size calculation
vention they received [chi-squared = .627, p = 0.361 The sample size for a fully-powered trial (derived from
(minimum expected count 4.09)]. Both the chiropractic data in this feasibility trial with an effect size of d = 0.38)
group and the sham group were equally satisfied with , using the DHI as the primary outcome measure, would
the care they received [mean (SD): chiropractic 3.58 (1. require a group size of 150 (i.e. 75 per group). Alterna-
0); sham 3.6 (0.7)], indicating that the sham protocol tively, using NDI as the primary outcome measure (with
provided sufficient patient satisfaction. an effect size of d = 0.46), would require a group size of
222 (i.e. 111 per group). These calculations exclude
Costs provision for XX%? drop-outs.
Advertising costs totalled AUD$43,679. Minor equipment
costs were AUD$395. Two registered chiropractors were Discussion
employed part-time as research assistants to set up the A fully-powered trial based on the current study would
procedures, screen participants and quantify outcome not be feasible in our setting using the current protocol.
measures; the cost for this was AUD$3033. In addition to However, a trial may be feasible with modifications to
one of the investigators (MFA), another experienced regis- the study location and recruitment strategies. Recruit-
tered chiropractor was employed to be available to provide ment of this study achieved sufficient numbers to calcu-
the weekly interventions at a cost of AUD$10,866. There- late sample sizes for potential larger trials. Blinding was
fore, total costs amounted to AUD$57,973. This translated acceptable in both groups.
Kendall et al. Chiropractic & Manual Therapies (2018) 26:14 Page 7 of 11

Table 1 Descriptions of clinical outcome measures

Clinical outcome Outcome measure Description Scoring
Dizziness Numerical rating Participants were asked to rate their dizziness experiences 0–10
scale (NRS11) ‘today’ with 0 indicating no dizziness and 10 very severe dizziness.
Dizziness Dizziness Handicap DHI is a comprehensively validated measure of disability due to 0–100
Inventory (DHI) dizziness from a range of causes [48], and has demonstrated
responsiveness to chiropractic interventions in older people [30].
Neck pain NRS11 Participants were asked to rate their neck pain experience ‘today’ 0–10
from 0 (no pain) to 10(very severe pain).
Neck pain Neck disability NDI is a 10 item questionnaire reporting pain and difficulties 0–100
index (NDI) with everyday activities [49].
Quality of life SF12 SF12 is a 12-point questionnaire that gives two combined scores: PCS: 0–50
a physical component score (PCS) and a mental component score (MCS). MCS: 0–50
Mood Disability Anxiety DASS contains 21 questions that report depression, anxiety and Depression 0–21
Stress Scale (DASS21) stress symptoms within the past week. Each component is scored Anxiety 0–21
separately. Interpretation is as follows: depression normal 0–4, Stress 0–21
moderate 5–8, severe 9–12 extremely severe 13–21; anxiety
normal 0–3, moderate 4–6, severe 7–9, and extremely severe 10–21;
stress normal 0–6, moderate 7–11, severe 12–16, and extremely
severe 17–21 [50].
Concerns of falling Falls Efficacy Scale FES-I is a 16 item questionnaire measuring the level of concern 16–64
International (FES-I) of falling undertaking activities and routines [51].
Cognitive function Montreal Cognitive MoCA is a 10-min screening assessment for cognitive impairment. 0–30
Assessment (MoCA) The domains are: attention and concentration, executive functions,
memory, language, visuo-constructional skills, conceptual thinking,
calculations, and orientation.
Physical function, Step test The number of times a person can repeatedly step one foot up Number of steps.
mobility and balance and down on and off a standard 7.5 cm height step in 15 s [52].
Both feet were tested and a combined score was used.
Timed Up and A measure of the time taken to stand up from a standard height The time taken in
Go (TUG) armchair, walk a distance of three metres, turn, return and sit seconds.
back down in the chair [53].
Functional reach The distance an individual can reach forward with their dominant The distance in
arm extended at horizontal, while standing. This is scored with centimetres.
the difference between starting reach and furthest reach in
centimetres [54].
Four-square The time taken to step in a sequence of forward, to the left, The time taken
step test backwards and to the right, and then reversed. Each step is in seconds.
performed over an obstacle to increase difficulty [55].

Recruitment in a facility with a high concentration of elderly people

We aimed for a sample size of 40 participants. However, with neck pain and dizziness such as a specialty clinic.
recruitment did not reach this pre-defined arbitrary num- Older adults experiencing neck pain and dizziness often
ber, even with a six-month extension to the recruitment have co-morbidities. However, chiropractic intervention is
period. If conducted in the same setting, to reach the esti- unlikely to impact dizziness due to known vestibular or
mated sample size of 150 participants (using DHI as the neurological origin, dizziness as a result of postural
primary outcome measure) would take more than four hypotension, or poly-pharmacy. Therefore, we recom-
years, assuming a similar recruitment rate. This study mend that the same exclusion of people with vestibular or
found that using online recruitment methods could be neurological causes of dizziness be used for the larger
useful in targeting older Australians over a wider geo- study. Excluding these participants based on self-reported
graphic area. On the other hand, newspaper advertise- previous diagnoses, however, may not capture these indi-
ments, while more expensive, captured a local population. viduals accurately. We recommend basing a future, larger
Considering the relatively high proportion (12%) of partic- trial in a rehabilitation setting such as a dizziness/falls
ipants who could not make the travel commitment to our clinic which provides access to clinical expertise and
single location, for future studies we recommended having equipment to rule out vestibular, neurological, hypotensive
multiple sites with sufficient geographical spread to in- and pharmacological causes of dizziness. Alternatively, the
crease recruitment and retention or performing the study larger trial can be based on an effective referral system
Kendall et al. Chiropractic & Manual Therapies (2018) 26:14 Page 8 of 11

Table 2 Pre- and post- intervention clinical outcome measures

Sham group Chiropractic group
Pre n = 11 Post n = 10 Pre n = 13 Post n = 12
Female (n) 5 (46%) 5 (50%) 6 (46%) 5 (42%)
Age (years) 72.55 (4.27) 72.9 (4.33) 74.23 (5.83) 73.75 (5.82)
Cognitive function (MoCA) (0–30)a 26.09 (1.92) 26.90 (1.60) 26.00 (2.16) 26.25 (2.67)
b
Dizziness (0–10) 4.00 (3.58) 3.50 (2.88) 3.85 (2.12) 2.58 (2.64)
Dizziness handicap (DHI) (0–100)b 44.00 (16.97) 36.40 (20.11) 40.77 (12.48) 28.33 (14.37)
b
Joint pain (NRS-11) (0–10) 2.27 (2.33) 3.30 (2.21) 2.69 (2.02) 2.92 (2.84)
Neck pain (NRS-11) (0–10)b 2.82 (1.78) 3.60 (2.12) 4.38 (2.36) 2.75 (2.49)
b
Neck pain (NDI) (0–100) 24.18 (8.22) 22.80 (6.20) 24.94 (12.87) 19.07 (12.50)
Concerns of falling (FES-I) (16–64)b 29.00 (5.71) 26.70 (6.29) 26.00 (5.61) 24.42 (5.21)
c
SF12 PCS (0–100) 36.20 (8.45) 40.18 (10.98) 42.12 (6.91) 43.96 (10.01)
SF12 MCS (0–100)c 49.20 (10.79) 49.98 (8.71) 47.76 (9.75) 52.90 (9.45)
Mood
Depression (DASS) (0–21)b 8.55 (4.99) 7.20 (6.20) 5.38 (4.03) 3.50 (4.52)
b
Anxiety (DASS) (0–21) 8.73 (6.28) 6.20 (6.43) 6.00 (2.58) 4.50 (2.97)
Stress (DASS) (0–21)b 10.73 (5.61) 7.60 (5.48) 9.08 (6.09) 8.33 (7.02)
Physical function
Functional reach (cm)d 32.41 (5.90) 30.60 (10.30) 29.93 (11.75) 31.25 (8.37)
d
Step test sum (n) 27.09 (6.16) 26.10 (7.08) 25.46 (7.09) 26.08 (8.45)
Four square step test (seconds)e 11.20 (2.51) 14.18 (8.24) 11.92 (2.95) 11.22 (3.18)
e
Timed up & go (seconds) 12.09 (2.87) 12.36 (4.11) 12.18 (2.70) 11.87 (3.67)
Correctly identified which group they were allocated to (n) 5 (50%) 8 (67%)
f
Treatment satisfaction (1–5) 3.60 (0.70) 3.58 (1.00)
Values displayed as mean(standard deviation) or number(percentage)
M mean, SD standard deviation, MoCA Montreal cognitive assessment, NDI neck disability index, DHI dizziness handicap inventory, PCS physical health composite
score, MCS mental health composite score, DASS depression anxiety and stress scale.
a
a lower score indicates reduced cognitive function
b
a higher score indicates greater symptoms
c
a higher score indicated greater quality of life
d
a higher score indicates greater physical function
e
a faster time indicates greater physical function
f
1-I feel much worse 2-I feel worse 3-I feel the same 4-I feel better 5-I feel much better

from a network of general medical practitioners. Exclusion function were significantly disappointed to the extent that
of people based on cognitive-function testing has been one of them lodged a complaint to the ethics committee.
shown to reduce the generalizability of findings [46], par- Future studies should consider how participants with po-
ticularly in older people with pain [47]. However, the val- tential impairments in cognitive function can be included,
idity of self-reported measures of pain and function using outcome measures that are still able to capture self-
depends on intact memory and executive function. Partic- reported pain and function. Alternatively, if a threshold of
ipants in this trial who were excluded based on cognitive cognitive function is used as an exclusion criteria in future
studies, procedures need be in place to direct excluded
Table 3 Proportion of improvement in primary clinical
participants to providers of therapeutics for neck pain and
outcomes of NDI and DHI in each group
dizziness to avoid disappointment.
Sham group (n = 10) Chiropractic group (n = 12)
% Improvement MCID* 30% 50% MCID* 30% 50% Compliance with outcome assessment
NDI 30% 10% 0% 58% 33% 25% The assessment regime was not too onerous for the par-
% Improvement MCID* 30% 50% MCID* 30% 50% ticipants and was completed in a timely manner. How-
DHI 50% 40% 20% 67% 33% 25% ever, several participants missed individual questions on
*Minimal Clinically Important Difference (MCID) for NDI is 19% [48] and for DHI
the questionnaires, and had to be prompted by the in-
is 18% [56] vestigator to fill these in. It was necessary to have an
Kendall et al. Chiropractic & Manual Therapies (2018) 26:14 Page 9 of 11

investigator review completed questionnaires to check of which are challenging. This is important information
that all questions had been completed at the end of the for future research. Furthermore, this was a feasibility
assessment session. study for determining effectiveness rather than efficacy.
This necessitated that the intervention given reflected a
Compliance with the intervention ‘real-world’ combination of intervention strategies that
The drop-out rate for participants was acceptable, with Australian chiropractors would provide. Effectiveness
less than 15% for each group. However, this was for a studies by nature are not mechanistic and cannot identify
relatively short intervention schedule of 4 visits over the ‘active ingredient’ in the intervention package. But
4 weeks. It cannot be determined from this study if a they do have higher external validity in their relevance
longer, more intensive or less intensive schedule would and applicability to actual practice. In this sense, this was
have good compliance. a trial comparing usual chiropractic care with sham chiro-
practic care. The intervention combination used here re-
Location flects the practice approach of a majority of Australian
Conducting the trial at a university campus meant that chiropractors (unpublished data), and follows contempor-
some participants became lost trying to find the building ary practice guidelines for the treatment of the elderly
location. Future studies should be conducted in an easy [38]. However, it does not reflect every chiropractor’s
to find location with convenient car parking facilities, practice style, particularly in its exclusion of manual ma-
and ideally with a choice of several sites to capture par- nipulation of the neck. This limits the relevance of this
ticipants who cannot travel long distances. study to trials of manual neck manipulation, as the bio-
mechanics of manual manipulative thrusts are likely to be
Interventions and blinding different from those delivered by an Activator instrument.
The protocol of using the Activator II™ instrument (set on This trial was limited by the short-term follow-up, and
zero) as a sham-chiropractic intervention appeared to no conclusions can be drawn about compliance with longer
achieve sufficient blinding in participants. This tool appears follow-up times. While the results of this trial advocate for
to be a useful blinding tool for future similar studies, par- conducting a fully-powered RCT at multiple locations, it
ticularly ones in which the experimental intervention con- did not test the feasibility of a protocol to ensure consistent
sists of Activator II™-instrument delivered manipulation. recruitment and data collection across several sites. These
issues should be investigated before such large-scale multi-
Costs centre studies are attempted. Another limitation of this
The costs and time to recruit sufficient numbers may be study is that the participants were excluded based on self-
a challenge for a larger fully-powered RCT. Use of a net- reported previous diagnoses of dizziness, and were not uni-
work of chiropractic intervention sites may increase formly screened by specialist medical staff to exclude other
feasibility of recruitment. The cost of AUD$2415 per causes of dizziness. This may have made the cohort of par-
participant may prove prohibitive if only small grant ticipants somewhat heterogeneous. However, this hetero-
funding is available. To reduce this expenditure, the lar- geneity reflects private practice that takes place within the
ger study could be based in a dizziness/falls clinic of a primary care setting. Furthermore, this study is limited by
general or rehabilitation hospital. The use of a specia- including participants with very low intensities of dizziness
lised or hospital recruitment setting would necessitate and neck pain. There was no threshold for severity or in-
modification of this protocol, and our results may not be tensity of dizziness or neck pain for inclusion. Setting of
reflective of the participants recruited in such settings. minimum DHI and NDI scores as inclusion criteria for fu-
ture studies is recommended, although this would lead to a
Harms lower proportion of interested participants being eligible.
Fifteen out of 23 participants did not report any harms.
Mild harms such as transient increases in neck pain or Conclusions
headache are common following chiropractic interven- A large trial in an Australian university setting using the
tion [28]. However, participants in the sham group also current protocol is not likely to be feasible primarily for
reported these harms, so these may be related to natural financial and recruitment reasons. However, a fully-powered
and non-specific effects [44]. clinical trial may be feasible at an appropriate hospital or re-
habilitation setting, which would require sample size of 150
Strengths and limitations (75 per group) or 222 (111 per group) using DHI or NDI as
Trials of non-pharmacological interventions for pain and the primary outcome measure respectively. Activator II™-in-
dizziness in older people are scarce. This trial provides strument-assisted sham intervention provided acceptable
useful information in the Australian context on recruiting blinding. The number and nature of the outcome measures
older people, and blinding for spinal manipulation, both used was not too onerous for the participants.
Kendall et al. Chiropractic & Manual Therapies (2018) 26:14 Page 10 of 11

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Competing interests
19. Boyd-Clark L, Briggs C, Galea M. Muscle spindle distribution, morphology,
JH is on the editorial board, and SDF is the deputy-editor in chief, of Chiro-
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Spine. 2002;27(7):694–701.
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20. Liu J, Thornell L, Pedrosa-Domellof F. Muscle spindles in the deep muscles
blinded from the editorial system from submission inception to decision.
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Otherwise, the authors declare no competing interests.
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21. Yacovino D. Cervical vertigo: myths, facts, and scientific evidence.
Publisher’s Note Neurologia. 2012; Sept 13;
Springer Nature remains neutral with regard to jurisdictional claims in 22. Malmstrom E, Karlberg M, Melander A, Magnusson M, Moritz U.
published maps and institutional affiliations. Cervicogenic dizziness - musculoskeletal findings before and after treatment
and long-term outcome. Disabil Rehabil. 2007;29(15):1193–205.
Author details 23. Matsui T, Ii K, Hojo S, Sano K. Cervical neuro-muscular syndrome: discovery
1 of a new disease group caused by abnormalities in the cervical muscles.
School of Health and Biomedical Sciences, RMIT University, PO Box 71
Bundoora, Melbourne, VIC 3083, Australia. 2School of Rehabilitation Therapy, Neurol Med Chir (Tokyo). 2012;52(2):75–80.
Queens University, Kingston, Canada. 3Department of Chiropractic, Macquarie 24. Yahia A, Ghroubi S, Jribi S, Malla J, Baklouti S, Ghorbel A, Elleuch M. Chronic
University, Sydney, Australia. 4Department of Sports Science and Clinical neck pain and vertigo: is a true balance disorder present? Ann Phys Rehabil
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