Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001719426
Ethics application status
Approved
Date submitted
6/12/2016
Date registered
14/12/2016
Date last updated
30/04/2019
Date data sharing statement initially provided
30/04/2019
Date results information initially provided
30/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative Effectiveness Study of Massage for Chronic Low Back Pain in Australia.
Scientific title
Comparative Effectiveness Study of the Clinical and Cost Outcomes of Massage for the Management of Chronic Low Back Pain in Australia.
Secondary ID [1] 290748 0
Nil known
Universal Trial Number (UTN)
U1111-1187-0702
Trial acronym
CEMT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 300125 0
Condition category
Condition code
Musculoskeletal 300002 300002 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 301085 301085 0 0
Other physical medicine / rehabilitation
Alternative and Complementary Medicine 301086 301086 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Massage therapy plus usual treatment for chronic low back pain over two months plus one extra month of follow-up. Massage therapists will be recruited from the Practitioner Research and Collaboration Initiative (PRACI) database and will be qualified massage practitioners with professional association membership and Professional Indemnity Insurance. Consenting therapists will screen prospective clients for inclusion in the study. The massage therapy treatment will be remedial therapy administered at the practitioner's discretion over at least two months of treatment. Treatment duration is anticipated to be 45 minutes to one hour. Treatment frequency will be determined by the massage therapist but it is anticipated to be once per week to once per fortnight. The treatment will take place at the massage therapist's own clinic.
All other treatments, including those from other manual therapists, will be recorded in the Participant Diary each week by the participant and this will be included in "usual treatment". No strategies will be used to improve adherence other than those used by the therapist in their normal clinical practice. Usual treatment is defined as any treatment the participant uses for chronic low back pain other than the massage treatment provided by the participating massage therapist.
Intervention code [1] 295787 0
Treatment: Other
Comparator / control treatment
The comparator is a retrospective assessment of clinical and cost outcomes of usual treatment for chronic low back pain over the month prior to commencement of massage treatment. The participants will act as their own control such that retrospective assessment and treatment intervention occurs in the same cohort.
Control group
Historical

Outcomes
Primary outcome [1] 300357 0
Comparison of standard treatment versus standard treatment plus massage for chronic low back pain using the Modified Graded Chronic Pain Scale (GCPS) scores.
Timepoint [1] 300357 0
Baseline and at one, two and three months of follow-up.
Primary outcome [2] 300358 0
Comparison of standard treatment versus standard treatment plus massage for chronic low back pain using the Oswestry Lower Back Pain Disability scores.
Timepoint [2] 300358 0
Baseline and at one, two and three months of follow-up.
Secondary outcome [1] 329773 0
Comparison of standard treatment versus standard treatment plus massage for chronic low back pain using the EQ-5D-5L – Europe Quality of Life 5 questionnaire scores for quality of life.
Timepoint [1] 329773 0
Baseline and at one, two and three months of follow-up.
Secondary outcome [2] 329774 0
Comparison of standard treatment versus standard treatment plus massage for chronic low back pain using the McGill Pain Scale scores.
Timepoint [2] 329774 0
Baseline and at one, two and three months of follow-up.
Secondary outcome [3] 329775 0
Comparison of standard treatment versus standard treatment plus massage for chronic low back pain using the Visual Analogue Scale (VAS) scores.
Timepoint [3] 329775 0
Baseline and at one, two and three months of follow-up.
Secondary outcome [4] 330143 0
Comparison of standard treatment versus standard treatment plus massage for chronic low back pain using the EQ-5D-5L – Europe Quality of Life 5 questionnaire scores for cost effectiveness.
Timepoint [4] 330143 0
Baseline and at one, two and three months of follow-up.
Secondary outcome [5] 330144 0
All adverse events will be recorded in the Case Report including severity and likelihood of relating to the intervention treatment.
Timepoint [5] 330144 0
At one, two and three months of follow-up.

Eligibility
Key inclusion criteria
1. Between the age of 18 and 80 years old
2. No massage for low back pain previously from a qualified, registered massage therapist
3. Grade 1 or higher on the Modified Graded Chronic Pain Scale
4. Chronic low back pain for longer than 6 months
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Disclaimer: The Key exclusion criteria is based on standard recommendations to avoid massage. The massage therapist is to decide if they would normally conduct massage on the participant or not.
1. Any person who is unable to read, understand or acknowledge what it means to be in the study.
2. A person with open wounds on the back including cuts, lacerations or grazes
3. Diagnosed muscle or tendon tears, partial tears or ruptures around the back or buttocks
4. A person with contusions on the back or buttocks
5. A person with burns, chilblains or broken bones.
6. Diagnosed periostitis or bursitis
7. A person with infections of the skin or soft tissue on their back
8. Diagnosed with haemophilia
9. A person with a solid tumour on their back or abdomen

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
All data will be analysed for intention to treat. The clinical data will analyse the data collected from the patient reported outcomes. The data will be analysed on STATA and will conduct ANOVA and other appropriate statistical analysis. Paired T tests will be conducted on the standard care and the massage treatment as they will be the same person. The cost-effectiveness will be analysed according to the EuroQual (EQ-5D). This quality of life tool has been chosen as it can be used to ascertain cost-effectiveness. Therefore, standard care versus standard care and massage for cost effectiveness analysis will be conducted via analysis of the EQ-5D. Cost of care will be calculated based upon services accessed by the participant as recorded in their participant diary.

A sample size calculation was conducted from the data collected from a literature search on massage for chronic lower back pain. As no cost effectiveness trial on massage for chronic low back pain has been conducted, the sample size calculation was obtained by looking at comparative effectiveness literature. The sample size from these studies varied from 12 participants to 579 with an average of 82 participants. The lower back pain studies were taken from these. The calculator used for this was https://select-statistics.co.uk/calculators/sample-size-calculator-two-means/ . Of this, the confidence level was set at 95%, the power was set at 80%, the hypothesised difference was 15 and the population variance was 550. This gave us a recommended sample size of 39. We also consulted with 5 professional advisors on the sample size and it was concluded that we would aim for 50 with a 20% attrition rate to ensure statistical significance could be achieved.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/01/2017
Actual
16/03/2017
Date of last participant enrolment
Anticipated
30/06/2018
Actual
31/05/2018
Date of last data collection
Anticipated
30/09/2018
Actual
30/09/2018
Sample size
Target
50
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 295086 0
Other Collaborative groups
Name [1] 295086 0
Australian Association of Massage Therapists (now Massage and Myotherapy Australia)
Country [1] 295086 0
Australia
Primary sponsor type
Other
Name
Endeavour College of Natural Health Office of Research
Address
Level 2, 269 Wickham Street, Fortitude Valley, Queensland, 4006, Australia
Country
Australia
Secondary sponsor category [1] 293906 0
University
Name [1] 293906 0
University of Technology Sydney
Address [1] 293906 0
15 Broadway, Ultimo NSW 2007
Country [1] 293906 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296439 0
University of Technology Sydney Human Research Ethics Committee
Ethics committee address [1] 296439 0
PO Box 123, BROADWAY NSW 2007
Ethics committee country [1] 296439 0
Australia
Date submitted for ethics approval [1] 296439 0
22/09/2016
Approval date [1] 296439 0
31/10/2016
Ethics approval number [1] 296439 0
ETH16-0812
Ethics committee name [2] 296440 0
Endeavour College of Natural Health Human Research Ethics Committee
Ethics committee address [2] 296440 0
Level 2, 269 Wickham Street, Fortitude Valley, Queensland, 4006
Ethics committee country [2] 296440 0
Australia
Date submitted for ethics approval [2] 296440 0
17/11/2016
Approval date [2] 296440 0
25/11/2016
Ethics approval number [2] 296440 0
20161132

Summary
Brief summary
The study design is a comparative effectiveness clinical trial with participants acting as their own controls. The research question is to establish if massage therapy in addition to standard care for chronic low back pain improves clinical and cost effectiveness outcomes compared to standard care alone. Standard care is defined as whatever the participant did for their low back pain over the month preceding recruitment
and their first massage treatment for the low back pain and will be assessed retrospectively. Clinical and cost effectiveness will be assessed using validated patient reported outcome measures (PROMs) and case reports to be completed at recruitment and again after each month of treatment for the prospective two month treatment phase plus one month of follow-up (three months total study duration per participant).
In addition, participant diaries for recording symptoms, medication and any adverse events experienced over each month will be distributed at recruitment and collected at each subsequent data collection point. Massage treatment will be determined by the participating massage therapists who will be recruited through the Practitioner Research and Collaboration Initiative (PRACI) and registered with an appropriate professional body. Participating therapists will screen potential clients for inclusion and obtain consent.

The primary research objective will be to substantiate the clinical and cost effectiveness of massage plus standard care for the treatment of chronic low back pain compared to standard care. If this study shows clinical and cost benefits from adjunctive massage therapy it has the potential to enhance clinical management and improve health outcomes for patients with chronic low back pain in Australia and internationally.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1290 1290 0 0
/AnzctrAttachments/371418-AAMT protocol_v3.docx (Protocol)
Attachments [2] 1291 1291 0 0
/AnzctrAttachments/371418-Participant Information Form_AAMT_v5.docx (Participant information/consent)
Attachments [3] 1292 1292 0 0
/AnzctrAttachments/371418-Informed Consent Form_AAMT_v_4.docx (Participant information/consent)
Attachments [4] 1293 1293 0 0
/AnzctrAttachments/371418-Collaborative-or-Cooperative-Research-Group-Agreement-PRACI_v4.docx (Other)
Attachments [5] 1294 1294 0 0
/AnzctrAttachments/371418-Massage therapist Information Sheet_v4.doc (Participant information/consent)
Attachments [6] 1295 1295 0 0
/AnzctrAttachments/371418-ETHICS APPROVAL AAMT.docx (Ethics approval)
Attachments [7] 1296 1296 0 0
/AnzctrAttachments/371418-HREC Approval Letter 20161132.pdf (Ethics approval)
Attachments [8] 1297 1297 0 0
/AnzctrAttachments/371418-Case Report AAMT_v4.doc (Supplementary information)
Attachments [9] 1298 1298 0 0
/AnzctrAttachments/371418-Case Report Final Section_Participant copy_v3.docx (Supplementary information)
Attachments [10] 1299 1299 0 0
/AnzctrAttachments/371418-AAMT PARTICIPANT DIARY v3.docx (Supplementary information)
Attachments [11] 1300 1300 0 0
/AnzctrAttachments/371418-ADVERSE EVENT LOG_v2.docx (Supplementary information)
Attachments [12] 1301 1301 0 0
/AnzctrAttachments/371418-20160811 Letter of Approval_PRACI.pdf (Ethics approval)

Contacts
Principal investigator
Name 68730 0
Dr Amie Steel
Address 68730 0
Endeavour College of Natural Health, Office of Research
Level 2, 269 Wickham Street, Fortitude Valley, Queensland, 4006
Country 68730 0
Australia
Phone 68730 0
+61 7 3253 9523
Fax 68730 0
+61 7 3257 1889
Email 68730 0
[email protected]
Contact person for public queries
Name 68731 0
Dr Janet Schloss
Address 68731 0
Endeavour College of Natural Health, Office of Research
Level 2, 269 Wickham Street, Fortitude Valley, Queensland, 4006
Country 68731 0
Australia
Phone 68731 0
+61 7 3253 9579
Fax 68731 0
+61 7 3257 1889
Email 68731 0
[email protected]
Contact person for scientific queries
Name 68732 0
Dr Amie Steel
Address 68732 0
Endeavour College of Natural Health, Office of Research
Level 2, 269 Wickham Street, Fortitude Valley, Queensland, 4006
Country 68732 0
Australia
Phone 68732 0
+61 7 3253 9523
Fax 68732 0
+61 7 3257 1889
Email 68732 0
[email protected]

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


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.