Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000069651
Ethics application status
Approved
Date submitted
20/12/2022
Date registered
20/01/2023
Date last updated
20/01/2023
Date data sharing statement initially provided
20/01/2023
Date results information initially provided
20/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
At home yoga treatment for adult students with jaw muscle pain
Scientific title
Effectiveness of yoga in adult students experiencing orofacial myofascial pain - A pilot randomised controlled trial
Secondary ID [1] 305700 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orofacial myofascial pain 327175 0
Condition category
Condition code
Musculoskeletal 324310 324310 0 0
Other muscular and skeletal disorders
Oral and Gastrointestinal 324311 324311 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Alternative and Complementary Medicine 324333 324333 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants were blinded and randomly assigned into one of two interventions, either a ‘yoga inclusive management program’ - Group A or an ‘active control standard care program’ - Group B. All participants were offered Standard self-care management for myofascial pain. This was done by a discussion on self-care management strategies and by providing an email copy of ‘Immediate management of Temporomandibular disorders’ document (Table 1).
Participants in Group A were provided a yoga mat and taught in groups (no more than 5) simple yoga activities to be performed daily for 30 minutes. The group then demonstrated to the instructor standardised activities which included 15 minutes of active physical yoga exercises, 15 minutes of breathing exercises and meditation. The activities included an initial warm-up exercise; a short sequence of 9 to 12 movements (sun salutation); 4 sustained yoga postures; breathing exercises; and a brief period of focused attention. A summary of exercise routines for each yoga session is presented in tables 2, 3 and 4. Further details and particulars of the yoga exercises are presented in appendix 1. Yoga sessions were conducted by a trained yoga instructor (with minimum 3 years’ experience) in a lecture room at 3 locations in Sydney: at the Westmead Centre for Oral Health (WCOH), at the Sydney Dental Hospital (SDH), and at The University of Sydney Camperdown Campus (USYD). Each participant was seen twice weekly by a researcher for 30 minutes and were instructed and reviewed on the daily activities. Participant adherence with the treatment was assessed with a self-report daily diary (appendix 3). Participants were emailed a copy of the session routines outlining the sequence of yoga exercises after they attended the sessions for weeks 1, 2, 3 and 4. This was done to assist them in practicing the yoga exercise at home. The total duration of this yoga intervention was 28 days.
Intervention code [1] 324137 0
Treatment: Other
Intervention code [2] 325168 0
Behaviour
Comparator / control treatment
The comparator group in our study was an ‘active control standard care program’ - Group B. Group B participants were provided with an un-heated heat pack (Head and Neck terry towel, Chattanooga group Inc., NSW, Australia) and a pedometer (SW 200 Yamax, YAMASA TOKEI KEIKI CO., LTD. Tokyo, Japan). They were instructed on the use and functions of the pedometer and on completing a daily walking task in an unobstructed and clean space for 15 minutes and on the application of the un-heated heat pack to the neck and masticatory muscles for 15 minutes. Participants then demonstrated these activities correctly. This sham treatment was to reduce the effect of differences in appointment duration and instructors interaction between the two groups.
These sessions were conducted by a researcher and administered as a group session (group of no more than 5 participants) at 3 locations in Sydney: at the Westmead Centre for Oral Health (WCOH), at the Sydney Dental Hospital (SDH), and at The University of Sydney Camperdown campus (USYD). Walking sessions was performed in an open space and application of unheated heat pack in a lecture room at the above locations. Each participant was seen twice weekly by a researcher for 30 minutes and were instructed and reviewed on the daily activities. Participant adherence with the treatment was assessed with a self-report daily diary. Participants were emailed a copy of the session routines outlining the sequence of walking exercises after they attended the sessions (table 5). This was done to assist them in practicing the active control program at home. The comparator group performed their program for the total duration of the study i.e. 28 days.
Control group
Active

Outcomes
Primary outcome [1] 332153 0
Change in pain intensity on an 11 point numerical rating scale (NRS) assessed using Graded Chronic Pain Scale (GCPS)
Timepoint [1] 332153 0
Baseline, 14 days post-intervention commencement, 28 days post -intervention commencement (primary endpoint).
Primary outcome [2] 333532 0
Change in jaw function limitation assessed using Jaw function limitation scale -20 (JFLS-20)
Timepoint [2] 333532 0
Baseline, 14 days post-intervention commencement, 28 days post-intervention commencement (primary end point)
Primary outcome [3] 333533 0
Change in pain palpation scores assessed clinically as per Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
Timepoint [3] 333533 0
Baseline, 28 days post-intervention commencement (primary end point)
Secondary outcome [1] 412391 0
Change in oral health-related quality of life assessed using Oral health impact profile (OHIP-14)
Timepoint [1] 412391 0
Baseline, 14 days post-intervention commencement, 28 days post-intervention commencement
Secondary outcome [2] 417442 0
Change in depressive symptoms assessed using Depression, Anxiety and Stress Scale (DASS)
Timepoint [2] 417442 0
Baseline, 14 days post-intervention commencement, 28 days post-intervention commencement
Secondary outcome [3] 417443 0
Change in anxiety symptoms assessed using Depression, Anxiety and Stress Scale (DASS)
Timepoint [3] 417443 0
Baseline, 14 days post-intervention commencement, 28 days post-intervention commencement
Secondary outcome [4] 417444 0
Change in stress symptoms assessed using Depression, Anxiety and Stress Scale (DASS)
Timepoint [4] 417444 0
Baseline, 14 days post-intervention commencement, 28 days post-intervention commencement
Secondary outcome [5] 417445 0
Change in pain catastrophizing assessed using Pain catastrophizing scale (PCS)
Timepoint [5] 417445 0
Baseline, 14 days post-intervention commencement, 28 days post-intervention commencement
Secondary outcome [6] 417446 0
Change in pain self-efficacy assessed using Pain self-efficacy questionnaire (PSEQ)
Timepoint [6] 417446 0
Baseline, 14 days post-intervention commencement, 28 days post-intervention commencement
Secondary outcome [7] 417447 0
Change in pain related disability assessed using Graded Chronic Pain Scale (GCPS)
Timepoint [7] 417447 0
Baseline, 14 days post-intervention commencement, 28 days post-intervention commencement
Secondary outcome [8] 417448 0
Change in pain-mapping area assessed using Digital pain map of head and neck.
Timepoint [8] 417448 0
Baseline, 14 days post-intervention commencement, 28 days post-intervention commencement
Secondary outcome [9] 417449 0
Change in the measurements of pain-free jaw mobility clinically assessed as per RDC/TMD. This is an additional primary outcome.
Timepoint [9] 417449 0
Baseline, 28 days post-intervention commencement (primary end point)
Secondary outcome [10] 417450 0
Change in the measurements of unassisted vertical jaw opening clinically assessed as per RDC/TMD.
Timepoint [10] 417450 0
Baseline, 28 days post-intervention commencement
Secondary outcome [11] 417451 0
Change in the measurements of assisted vertical jaw opening clinically assessed as per RDC/TMD.
Timepoint [11] 417451 0
Baseline, 28 days post-intervention commencement
Secondary outcome [12] 417452 0
Participants response on level of benefit assessed using Post study feedback form. The post study feedback form was designed specifically for this study (Appendix 2).
Timepoint [12] 417452 0
28 days post-intervention commencement
Secondary outcome [13] 417453 0
Participants indicating their willingness to continue the assigned activity after completion of the study assessed using post study feedback form. The post study feedback form was designed specifically for this study (Appendix 2).
Timepoint [13] 417453 0
28 days post-intervention commencement
Secondary outcome [14] 417454 0
Participants attitude in response to "Which group you think you were in?" assessed using post study feedback form. The post study feedback form was designed specifically for this study (Appendix 2).
Timepoint [14] 417454 0
28 days post intervention commencement

Eligibility
Key inclusion criteria
- Participants diagnosed with myofascial pain of the masticatory (jaw) muscles were invited to participate for the study.
- Volunteers who could participate for the entire duration (28 days) of the study were informed about the details of the study
- Able to give informed consent.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Currently undergoing any other management for facial pain.
• Temporomandibular disorder diagnosis other than myofascial orofacial pain.
• Patients with severe debilitating cardiovascular, respiratory, musculoskeletal and/or neurological diseases.

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)
Randomisation was performed by a nurse who was not directly involved in the study. Participant names written on folded pieces of paper placed in a container were randomly drawn and allocated into one of the 2 groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation was performed. Participant names written on folded papers were randomly drawn and allocated into one of the 2 groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Blinding was preserved from allocation concealment until the first activity (yoga/active control) session. Keeping the study participants unaware of the assigned intervention until the end of the study could not be successfully implemented in the yoga group. It is to be noted that participants in Group A were unaware of the activities in Group B and vice versa.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the outcome criteria, per protocol approach was used. Age, gender and all other outcome measures were analysed using Independent t-test or Mann Whitney test for continuous variables and chi square test for categorical variables to assess the similarities and differences between the two intervention groups at baseline.
Calculating assessment values for primary and secondary outcomes: The change in each outcome measure, except the clinical parameters, between the baseline and day 14 and between baseline and at the end of the study were calculated. The change in clinical parameters between beginning and end of the study were calculated.
To determine the effectiveness of intervention, individual changes were calculated, and the group means of the changes were analysed using the Mann Whitney test for all jaw muscle pain outcome measures. All data were expressed as mean, median, Standard Deviation and percentiles (25,75). Statistical analyses were conducted using SPSS for Windows (version 19: SPSS Inc, Chicago, Illinois, USA).
For the post study feedback, descriptive statistics were used and p values were calculated from independent t test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/05/2011
Date of last participant enrolment
Anticipated
Actual
5/10/2011
Date of last data collection
Anticipated
Actual
20/11/2011
Sample size
Target
30
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 39180 0
2010 - Surry Hills
Recruitment postcode(s) [2] 39179 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 310060 0
Charities/Societies/Foundations
Name [1] 310060 0
Australian Dental Research Foundation Inc
Country [1] 310060 0
Australia
Primary sponsor type
Individual
Name
Prof Christopher Peck
Address
The Michael J. Cousins Pain Management and Research Centre
Douglas Building - Ground Floor, Reserve Road
St Leonards New South Wales 2065
Country
Australia
Secondary sponsor category [1] 311111 0
Individual
Name [1] 311111 0
Priya Thimma Ravindranath
Address [1] 311111 0
Department of Oral Surgery and Orofacial Pain,
King's College Hospital
Denmark Hill
London, SE5 9RS
Country [1] 311111 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309751 0
South West Area Health Service (SWAHS) Human Research Ethics Committee (HREC)
Ethics committee address [1] 309751 0
NSW Health,
Human Research Ethics Committee (Westmead Campus)
Reserach Office, Room 2020 Clinical Sciences
Westmead Hospital, Hawkesbury Road, Westmead
NSW 2145
Ethics committee country [1] 309751 0
Australia
Date submitted for ethics approval [1] 309751 0
05/11/2010
Approval date [1] 309751 0
23/11/2010
Ethics approval number [1] 309751 0
HREC2006/5/4.4(2342)
Ethics committee name [2] 311405 0
The University of Sydney - Human Research Ethics Committee
Ethics committee address [2] 311405 0
The University of Sydney - Human Research Ethics Committee
Level 6, Jane Foss Russell Building - G02,
City Road, Camperdown,
The University of Sydney
NSW 2006
AUSTRALIA
Ethics committee country [2] 311405 0
Australia
Date submitted for ethics approval [2] 311405 0
10/01/2011
Approval date [2] 311405 0
27/01/2011
Ethics approval number [2] 311405 0
[SA/KFG]

Summary
Brief summary
Background & Aim:
Myofascial pain or jaw muscle pain is a common orofacial pain resulting in impairment of jaw function, and high health-care costs. It is most common in the 20–40-year age range. The aim of this study is to evaluate the feasibility, acceptability, and effectiveness of yoga in adult students experiencing myofascial pain.
Methods:
Subjects were recruited from a university student population and invited to learn more about the study through advertisements by email. Those interested were provided a jaw health screening questionnaire and if self-reporting facial pain they were invited for clinical examination to confirm orofacial myofascial pain (using standardised Research diagnostic criteria for Temporomandibular disorders [RDC/TMD]). 25 students with diagnoses of myofascial pain volunteered for this double-blind randomized controlled study. Participants undergoing other management for facial pain and TMDs were excluded. Participants were randomized to one of two interventions, either a yoga inclusive management programme or an active control standard care programme. Both groups received the intervention for 28 days. The outcome measures analysed were the change in pain intensity on an 11-point numerical rating scale and change in pain location and distribution using digitalized pain mapping software. Jaw mobility, oral health related quality of life and cognitive factors related to the participant’s understanding of pain were determined at baseline, at 14 days and at the end of 28 days. Change in outcome measures between baseline and (outcome points) were analyzed using Mann- Whitney test.
Hypothesis
That there will be a statistically significant difference in the treatment benefits between a yoga exercise inclusive management program as compared to active control standard care for the management of jaw muscle pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115266 0
Prof Christopher Peck
Address 115266 0
Michael J Cousins Pain Management and Research Centre
Ground Floor, Douglas Building
Royal North Shore Hospital, Reserve Road, St Leonards NSW 2065
Country 115266 0
Australia
Phone 115266 0
+61 2 9463 1500
Fax 115266 0
Email 115266 0
chris.peck@sydney.edu.au
Contact person for public queries
Name 115267 0
Prof Christopher Peck
Address 115267 0
Michael J Cousins Pain Management and Research Centre
Ground Floor, Douglas Building
Royal North Shore Hospital, Reserve Road, St Leonards NSW 2065
Country 115267 0
Australia
Phone 115267 0
+61 2 9463 1500
Fax 115267 0
+61 (02) 9463 1050
Email 115267 0
chris.peck@sydney.edu.au
Contact person for scientific queries
Name 115268 0
Dr Priya Thimma Ravindranath
Address 115268 0
Faculty of Dentistry, Oral & Craniofacial Sciences,
King’s College London, UK (Denmark Hill Campus)
16 De Crespigny Park,
Denmark Hill,
London, SE5 8AF
Country 115268 0
United Kingdom
Phone 115268 0
+447846340333
Fax 115268 0
Email 115268 0
priya.thimma_ravindranath@kcl.ac.uk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17274Study protocol  priya.thimma_ravindranath@kcl.ac.uk 383052-(Uploaded-06-10-2022-02-07-17)-Study-related document.doc
17275Ethical approval  chris.peck@sydney.edu.au Approval number - Human Research Ethics committee ... [More Details] 383052-(Uploaded-06-10-2022-02-24-09)-Study-related document.pdf
17276Ethical approval  manish.bhutada@sydney.edu.au RESEARCH INTEGRITY Human Research Ethics Committe... [More Details] 383052-(Uploaded-06-10-2022-02-24-26)-Study-related document.pdf
17279Informed consent form    383052-(Uploaded-06-10-2022-02-25-49)-Study-related document.doc
18026Other    Table 1-5 presenting standard care information, cl... [More Details] 383052-(Uploaded-12-01-2023-04-22-15)-Study-related document.pdf
18027Other    Appendix 1 presenting details and particulars of y... [More Details] 383052-(Uploaded-12-01-2023-04-23-36)-Study-related document.pdf
18028Other    Appendix 2: Post study feedback form 383052-(Uploaded-12-01-2023-04-25-19)-Study-related document.pdf
18029Other    Appendix 3: Self reporting daily diary 383052-(Uploaded-12-01-2023-04-25-57)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.