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Trial registered on ANZCTR


Registration number
ACTRN12614000841673
Ethics application status
Approved
Date submitted
14/07/2014
Date registered
7/08/2014
Date last updated
18/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of equipment Pilates and yoga as adjuncts to home-based exercises for chronic non-specific neck pain
Scientific title
The effects of equipment Pilates and yoga as adjuncts to home-based exercises on pain, well-being and disability in adults with non-specific neck pain
Secondary ID [1] 284979 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic non-specific neck pain 292482 0
Condition category
Condition code
Musculoskeletal 292792 292792 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 292972 292972 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised to either Equipment Pilates + Exercises or Yoga + Exercises

EQUIPMENT PILATES
Range of Pilates exercises focusing on stretching, breathing, and whole body movement and muscular stabilisation:
60mins, 2x / week, for 8 weeks.
Personal instruction on all exercises for every session on an individual basis, by 4th or 5th year osteopathy student who is also Pilates qualified and experienced.
Instruction ongoing throughout each class.
Attendance register kept to monitor adherence.

YOGA
Hatha Yoga - stretching, strengthening, breathing and relaxation focused:
60mins, 2x / week, for 8 weeks.
Personal instruction on all exercises for every session on an individual basis, by 4th or 5th year osteopathy student who is also yoga qualified and experienced.
Instruction ongoing throughout each class.
Attendance register kept to monitor adherence.

EXERCISES
Range of appropriate exercises to relieve non-specific neck pain, such as back, neck and shoulder stretching and strengthening
5-10 mins, 7x / week, for 8 weeks
Initial personal instruction on all exercises, for approximately 30 minutes until correct technique can be performed.
Instruction given by a 4th or 5th year osteopathy student who is also either Pilates or yoga qualified and experienced (one of the same two instructors who are delivering the Pilates and yoga interventions).
Participants will have access a YouTube video with full descriptions of exercises for use during the study.
Adherence monitored by way of weekly phone/email contact.

Intervention code [1] 289807 0
Rehabilitation
Comparator / control treatment
EXERCISES
Range of appropriate exercises to relieve non-specific neck pain, such as back, neck and shoulder stretching and strengthening
5-10 mins, 7x / week, for 8 weeks
Initial personal instruction on all exercises, for approximately 30 minutes until correct technique can be performed.
Instruction given by a 4th or 5th year osteopathy student who is also either Pilates or yoga qualified and experienced (one of the same two instructors who are delivering the Pilates and yoga interventions).
Participants will have access a YouTube video with full descriptions of exercises for use during the study.
Adherence monitored by way of weekly phone/email contact.
Control group
Active

Outcomes
Primary outcome [1] 292641 0
Pain as measured via visual analogue scale (VAS)
Timepoint [1] 292641 0
4, 9, and 12 weeks.
Primary outcome [2] 292642 0
Disability as measured via Northwick Park Neck Pain Questionnaire (NPQ)
Timepoint [2] 292642 0
4, 9, and 12 weeks.
Primary outcome [3] 292643 0
Quality of Life measured via Health Outcomes Questionnaire Short-Form 36 (SF36)
Timepoint [3] 292643 0
4, 9, and 12 weeks.
Secondary outcome [1] 309399 0
Credibility/expectancy perception measured via Credibility Expectancy Questionnaire (CEQ)
Timepoint [1] 309399 0
4, 9, and 12 weeks.

Eligibility
Key inclusion criteria
Neck pain at least 30mm/100mm for most days in the previous 12 weeks

Non-specific neck pain that has not required imaging

Able to read, speak and comprehend English language
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current ACC claim for neck pain of 90 days of less

Neurological symptoms determined by the presence of sensory abnormalities, weakness, or altered reflexes

Symptoms related to a motor vehicle accident or significant trauma that has occurred in the last 6 months

Undergone neck or invasive spinal surgery in the previous 12 months

Diagnosis or signs of serious pathology, such as fracture, inflammatory disorders, or infection

Pregnancy or attempting to become pregnant

Suffering from chronic and/or acute neck pain due to specific causes, e.g. disc protrusion, whiplash, congenital deformity of the spine, spinal canal stenosis, neoplasm, inflammatory rheumatic disease, or active oncologic disease

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)
Allocation involved contacting the holder of the allocation schedule who was not involved in participant recruitment and not in contact with prospective participants.

A block randomisation for 3 arms (Pilates + exercises; yoga + exercises and Exercises only) generated in advance of recruitment for the target sample size, using the website http://www.randomization.org, and held by an investigator not involved in the recruitment process. Upon enrollment, the allocation was requested and emailed to study personnel involved with participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using the website http://www.randomization.org
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analysis of Variance for changes in primary and secondary outcomes

Correlational analysis of potentially explanatory variables and primary and secondary outcomes

Calculation of effect size using G*Power 3 (Faul, Erdfelder, Lang & Buchner, 2007) has taken into account a comparison of changes from before to after the intervention using dependent differences tests as well as differences between independent groups. Three previous studies reviewed (Rydeard et al, 2007; Cramer et al, 2013; Ezar et al, 2012) do not show clear differences in effect sizes noted for pain in change from baseline following yoga and Pilates interventions (ES range from 2.8 – 3.6 reductions in pain) compared to differences in changes in pain noted between treatment and exercise control groups (ES range from 1.0 – 2.5 more reduction in intervention compared to control groups). When comparing changes in a treatment versus control group, a sample size of 17 in each group would be required to detect a difference in change between groups of ES = 1 (the smallest effect reported in the above studies), assuming a level of significance of 0.05, and statistical power of 80%. To allow for withdrawal from the study and non-compliance, an initial sample size of 20 per group is sought. A sample of 19 in each intervention group would also provide sufficient power to detect changes from pre- to post-intervention of ES = 0.7 using the above assumptions, much smaller than those effects reported in the above studies.

Faul. F., Erdfelder, E., Lang, A.G., & Buchner .A. (2007) G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39(2), 75-191.

Rydeard, R., Leger, A., Smith, D., 2007. Pilates-based theraputic exercise: effect on subjects with nonspecific chronic low back pain and functional disability: a randomized controlled trial.  Journal of Orthopaedic and Sports Physical Therapy. 36(7),472-484

Cramer, H., Lauche, R., Hohmann, C., Ludtke, R., Haller, H., Michalsen, A., Langhorst, J., & Dobos, G. (2013). Randomized-controlled Trial Comparing Yoga and Home-based Exercise for Chronic Neck Pain. Clinical Journal of Pain, 29(3), 216-23. doi: 10.1097/AJP.0b013e318251026c.

Ezar, J., Nagarathna, R., Yogitha, B., & Nagendra, H.R. (2012). Effects of an integrated approach of hatha yoga therapy on functional disability, pain, and flexibility in osteoarthritis of the knee joint: a randomised controlled study. The Journal of Alternative and Complementary Medicine, 18(5), 463-472.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6213 0
New Zealand
State/province [1] 6213 0
Auckland region

Funding & Sponsors
Funding source category [1] 289601 0
University
Name [1] 289601 0
Unitec Institute of Technology
Address [1] 289601 0
Private Bag 92025
Victoria Street West
Auckland 1142
Country [1] 289601 0
New Zealand
Primary sponsor type
Individual
Name
Catherine Bacon
Address
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 288284 0
None
Name [1] 288284 0
Address [1] 288284 0
Country [1] 288284 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291336 0
Unitec Research Ethics Committee
Ethics committee address [1] 291336 0
Unitec Institute of Technology
Private Bag 92025
Auckland 1142
Ethics committee country [1] 291336 0
New Zealand
Date submitted for ethics approval [1] 291336 0
11/06/2014
Approval date [1] 291336 0
07/07/2014
Ethics approval number [1] 291336 0
2014-1043

Summary
Brief summary
The aim of this study is to determine the degree to which equipment Pilates and/or yoga are efficacious for treating chronic non-specific neck pain, when applied as an additional intervention to therapeutic exercises.

Our hypothesis is that the holistic approach of these therapies will alleviate pain and disability and improve quality of life for people with chronic neck pain when applied with the type of exercises usually prescribed by manual therapists, compared to prescription of these exercises alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49930 0
Dr Catherine Bacon
Address 49930 0
Department of Community and Health Services
Osteopathy Division
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
Country 49930 0
New Zealand
Phone 49930 0
+64 9 815 6794
Fax 49930 0
Email 49930 0
cbacon@unitec.ac.nz
Contact person for public queries
Name 49931 0
Dr Catherine Bacon
Address 49931 0
Department of Community and Health Services
Osteopathy Division
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
Country 49931 0
New Zealand
Phone 49931 0
+64 9 815 6794
Fax 49931 0
Email 49931 0
cbacon@unitec.ac.nz
Contact person for scientific queries
Name 49932 0
Dr Catherine Bacon
Address 49932 0
Department of Community and Health Services
Osteopathy Division
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
Country 49932 0
New Zealand
Phone 49932 0
+64 9 815 6794
Fax 49932 0
Email 49932 0
cbacon@unitec.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary