Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000234415
Ethics application status
Approved
Date submitted
29/01/2016
Date registered
22/02/2016
Date last updated
23/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chiropractic care and perceived ankle instability
Scientific title
The effect of a single session of chiropractic care on functional measures associated with perceived ankle instability
Secondary ID [1] 288444 0
None
Universal Trial Number (UTN)
U1111-1178-8187
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle Instability
 297471 0
Condition category
Condition code
Alternative and Complementary Medicine 297656 297656 0 0
Other alternative and complementary medicine
Physical Medicine / Rehabilitation 297739 297739 0 0
Other physical medicine / rehabilitation
Musculoskeletal 297740 297740 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a single session of chiropractic care for the intervention group. The chiropractic session will approximately take 10 minutes. The entire spine and both sacroiliac joints will be assessed for segmental dysfunction, and treated where deemed necessary by a registered chiropractor. The peripheral joints will also be assessed and adjusted when necessary. The clinical indicators that will be used to assess joint function prior to and after each intervention include assessing for tenderness to palpation of the relevant joints, manually palpating for restricted range of motion, assessing for palpable asymmetric muscle tension, and any abnormal or blocked joint play and end-­-feel of the joints. All of these biomechanical characteristics are used by the chiropractors as clinical indicators of joint dysfunction (Kockum & Heijne, 2014). All of the manipulations carried out in this study will be high-­-velocity, low-­-amplitude thrusts to the appropriate joints. This is a standard manipulation technique used by chiropractors, and is also referred to as spinal or peripheral joint adjustments. The mechanical properties of this intervention have been investigated; and although the actual force applied to the subject's spine depends on the therapist, the patient, and the spinal location of the manipulation, the general shape of the force-­-time history of spinal manipulations is very consistent (Hessell, Herzog, Conway, & McEwen, 1990) and the duration of the thrust is always less than 200 milliseconds (Herzog, 1996). The high-­-velocity type of manipulation is chosen specifically because previous research has shown that reflex electromyographic activation observed after manipulations only occurred after high-­- velocity, low-­-amplitude manipulations (as compared with lower-­-velocity mobilizations) (Herzog, Conway, Zhang, Gal, & Guimaraes, 1995). This manipulation technique has also been previously used in studies that have investigated the neurophysiological effects of spinal manipulation (Haavik & Murphy, 2012). The washout period for this project is 1 week.
Intervention code [1] 293770 0
Rehabilitation
Intervention code [2] 293837 0
Treatment: Other
Comparator / control treatment
The subject’s head and/or spine and peripheral joints will be moved in ways that include passive and active movements, similar to what is done by the chiropractor that provide actual chiropractic treatment during the spinal manipulation intervention. Thus, this control intervention involves the subjects being moved into the manipulation setup positions similar to how the chiropractor would normally setup a subject prior to applying the thrust to the spine to achieve the manipulations. Loading a joint, as is done prior to spinal manipulation has been shown to alter paraspinal proprioceptive firing in anesthetized cats (Pickar & Wheeler, 2011) and therefore will be carefully avoided by ending the movement prior to end-­-range-­-of-­-motion when passively moving the subjects. No spinal manipulation will be performed during any control intervention. This control intervention is intended to act as a sham treatment session as well as to act as a physiological control for possible changes occurring due to the cutaneous, muscular or vestibular input that would occur with the type of passive and active movements involved in preparing a subject/patient for a manipulation.
Control group
Active

Outcomes
Primary outcome [1] 297192 0
The outcome measure will be assessed pre and post manipulation sessions and pre and post control intervention session. Ankle joint function will be assessed using an acelerometer, inclinometer, goniometer.
Timepoint [1] 297192 0
Immediately pre and post manipulation sessions and pre and post control intervention session
Secondary outcome [1] 320294 0
None
Timepoint [1] 320294 0
None

Eligibility
Key inclusion criteria
15 subjects will be recruited via advertising within the New Zealand College of Chiropractic community. Participants may include students, staff, faculty, and previous patients of the College’s chiropractic centre and also family, friends and acquaintances of the New Zealand College of Chiropractic community. The experimental protocol will be advertised inviting volunteers that have experienced more than one ankle sprain and have signs of perceived ankle instability. Inclusion criteria will be history of ankle sprain with a score of below 27 on the Cumberland Ankle Instability Tool (CAIT) questionnaire (Hiller et al., 2006). Further, subjects must be English speaking and aged 18-50.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria will be recent osteomioligamentar injury (within the last month) and/or vestibular dysfunction. Subjects will also be ineligible to participate if they exhibit no evidence of vertebral subluxations, have absolute contraindications to spinal adjustment, have experienced previous significant adverse reactions to chiropractic care, or they are suffering from a current lower limb disorder/dysfunction that would make them unable to carry out data recording sessions (e.g. severe sprain/strain/fracture).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
A within-­-subject crossover design with a one-­-week washout period between interventions will be used.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A Split plot analysis (Mixed design) and a multifactorial repeated measures ANOVA will be used to assess for within and between group differences. TIME (pre and post intervention measures) and INTERVENTION (Chiro vs. Control) will be used as factors. A priori pairwise comparisons of the pre and post intervention data will be carried out when an interactive effect is significant. Significance will be set at P = .05

Allocation of participants will be carried out using an online randomisation programme. The randomisation sequence will created using Minimizer (Microsoft Corp., Redmond, WA) with a 1:1 allocation to control and experimental groups. Allocation will remain concealed until after the baseline assessment has taken place. Participants and the chiropractors providing care during the study will not be blinded to group allocation. Outcomes assessors and data analysts will remain blinded to group allocation throughout the study period.

Sample size calculations are based on detecting a difference in a continuous response variable from independent control and experimental participants with one control per experimental participant. Calculations are made based on the changes observed in our previous studies that investigated the effect of chiropractic care on proprioception (Haavik & Murphy, 2011; Holt, 2014). If the true difference in outcomes between the experimental session and the control session has an effect size of 0.5 we will need 11 participants to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with the test of this null hypothesis is 0.05. To allow for attrition during the trial and relative uncertainty relating to power outcomes we will enroll 15 participants in this trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/02/2016
Date of last participant enrolment
Anticipated
20/05/2018
Actual
19/04/2018
Date of last data collection
Anticipated
Actual
3/05/2018
Sample size
Target
15
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 7562 0
New Zealand
State/province [1] 7562 0

Funding & Sponsors
Funding source category [1] 292789 0
Other
Name [1] 292789 0
New Zealand College of Chiropractic
Country [1] 292789 0
New Zealand
Primary sponsor type
Other
Name
New Zealand College of Chiropractic
Address
6 Harrison Road Mount Wellington Auckland 1060
Country
New Zealand
Secondary sponsor category [1] 291526 0
None
Name [1] 291526 0
Not applicable
Address [1] 291526 0
Not applicable
Country [1] 291526 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294280 0
Health and Disability Ethics Committees
Ethics committee address [1] 294280 0
Ethics committee country [1] 294280 0
New Zealand
Date submitted for ethics approval [1] 294280 0
29/01/2016
Approval date [1] 294280 0
12/02/2016
Ethics approval number [1] 294280 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63174 0
Dr Imran Niazi
Address 63174 0
Dr. Imran Niazi
New Zealand College of Chiropractic
6 Harrison Road Mount Wellington Auckland 1060
Country 63174 0
New Zealand
Phone 63174 0
+6495266789
Fax 63174 0
Email 63174 0
[email protected]
Contact person for public queries
Name 63175 0
Kelly Holt
Address 63175 0
Dr. Kelly Holt
New Zealand College of Chiropractic
6 Harrison Road Mount Wellington Auckland 1060
Country 63175 0
New Zealand
Phone 63175 0
+6495266789
Fax 63175 0
Email 63175 0
[email protected]
Contact person for scientific queries
Name 63176 0
Kelly Holt
Address 63176 0
Dr. Kelly Holt
New Zealand College of Chiropractic
6 Harrison Road Mount Wellington Auckland 1060
Country 63176 0
New Zealand
Phone 63176 0
+6495266789
Fax 63176 0
Email 63176 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.