Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000270314
Ethics application status
Approved
Date submitted
23/05/2008
Date registered
28/05/2008
Date last updated
25/07/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Tai chi for long-term low back pain
Scientific title
The effects of tai chi exercise on pain and disability in subjects with long-term non-specific low back pain: a randomised controlled trial
Secondary ID [1] 566 0
nil
Universal Trial Number (UTN)
Trial acronym
TAICHI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long-term low back pain 3183 0
Condition category
Condition code
Musculoskeletal 3344 3344 0 0
Other muscular and skeletal disorders
Alternative and Complementary Medicine 3345 3345 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tai Chi Exercise Program: based on sun style tai chi, which compared to other styles of tai chi, involves less deep-knee bending promoting a more upright stance, a decreased stepping distance which utilizes more forward, backward and side-stepping movements. This tai chi program has 21 moves in total and was designed by Dr. Paul Lam, General Physician and Tai Chi Master. It has been entitled Tai Chi for Back Pain and can be viewed on DVD of same name. The dosage of treatment will be18 sessions over a 10 week period (2x/week for 8 weeks and 1x/week for 2 weeks). This dosage is consistent recent tai chi research and reflects the norm for general tai chi practice in the community.
Intervention code [1] 2915 0
Rehabilitation
Comparator / control treatment
The control treatment is no tai chi.
All participants are allowed to continue with their usual health care for their low back pain. We have defined usual as participating in these therapies for a minimum of 4 weeks prior to trial entry. The participants of both treatment and control are asked not to seek new forms of treatment for their back pain during the 10 week period of the trial.
Control group
Active

Outcomes
Primary outcome [1] 4234 0
Bothersomeness of Pain Symptoms measured with the 0-10 Bothersomeness Numerical Rating Scale
Timepoint [1] 4234 0
10 weeks after randomisation
Secondary outcome [1] 7150 0
Self-reported Disability measured with
The Quebec Pain Disability Scale
Timepoint [1] 7150 0
10 weeks after randomisation
Secondary outcome [2] 7151 0
Pain measured with The Pain Disability Index
Timepoint [2] 7151 0
10 weeks after randomisation
Secondary outcome [3] 7152 0
Subject's global impression of change measured with the Global Perceived Effect Scale (-5 to 5)
Timepoint [3] 7152 0
10 weeks after randomisation
Secondary outcome [4] 7153 0
Health-related Quality of Life measured with Short Form 36 (SF-36) Health Survey v2
Timepoint [4] 7153 0
10 weeks after randomisation

Eligibility
Key inclusion criteria
1. Non-specific low back pain +/- leg pain of at least 3 months duration.
2. A score of “moderate” or higher on item 7 or 8 of the SF-36
3. Not currently receiving any new treatments within the last 4 weeks for their low back pain
4. Agree not to seek any new treatments for their back pain during the course of the trial
5. Aged greater than 18 and less than 75 years
6. English Speaker
7. Literate in English
8. Expects to continue residing in Sydney for study duration.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Suspected or confirmed serious spinal pathology (fracture, metastatic, inflammatory or infective diseases of the spine, cauda equina syndrome/widespread neurological disorder).
2. Suspected or confirmed pregnancy
3. Unable to speak English
4. Nerve root compromise (2 of strength, reflex or sensation affected for same nerve root)
5. Spinal surgery.
6. Scheduled for major surgery during treatment or follow-up period
7. Any of the contraindications to exercise listed on page 42 of the American College of Sports Medicine guidelines (ACSM's Guidelines for Exercise Testing and Prescription, 1995).
8. If participant is receiving workers compensation, all relevant treatment parties need to agree to Tai Chi treatment.
9. Participation in a tai chi program within the last 6 months.

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)
Potential participants will be screened via telephone during their initial telephone call to determine eligibility. All screening questionnaires are listed in a booklet separate to the assessment booklet.

If the volunteer is determined to be eligible for the study, they will be asked to attend an initial group session where they and 7 others will fill out the baseline assessment booklet. Upon completion of the assessment booklet they will be assigned a sealed opaque envelope from a randomly generated sequence that contains the treatment code and allocates them to either receive the tai chi intervention or continue with their usual care and join the wait-list control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be generated using the random number function in excel. The treatment codes will be placed in consecutively numbered sealed opaque envelopes. Participants will be allocated to treatment by selecting the next envelope in sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 864 0
2000

Funding & Sponsors
Funding source category [1] 3421 0
Self funded/Unfunded
Name [1] 3421 0
Country [1] 3421 0
Primary sponsor type
University
Name
Faculty of Medicine, The University of Sydney
Address
The George Institute for International Health
Musculoskeletal Division
Level 7, 341 George St.
Sydney, NSW
2000
Country
Australia
Secondary sponsor category [1] 3064 0
None
Name [1] 3064 0
Address [1] 3064 0
Country [1] 3064 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5444 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 5444 0
Research Office
Level 3, Old Teacher?s College
Camperdown Campus, Paramatta Road
Sydney, NSW 2006
Ethics committee country [1] 5444 0
Australia
Date submitted for ethics approval [1] 5444 0
Approval date [1] 5444 0
20/11/2007
Ethics approval number [1] 5444 0
10452

Summary
Brief summary
One in ten Australians suffer from long-term low back pain (Australian Institute of Health and Welfare, 2000). Long-term low back pain is extremely difficult to treat because it does not respond to most treatments, leading to an enormous social and economic burden. Exercise therapy may provide a potential solution as there is biological plausibility for effect. However, the types of exercise to be used and resulting efficacy have not been well established. Tai chi has been used as an exercise prescription as part of Traditional Chinese Medicine for many years. Recent studies have shown that tai chi is a safe exercise for elderly adults suffering from arthritis (Kirstiens 1991). Since a high percentage of patients with long-term low back pain are over 55yrs, tai chi should also be considered as a potential exercise in the treatment plan for this group. However, there are few randomised controlled trials studying tai chi and its efficacy for improving pain is not well known. We propose to conduct the first randomised-controlled trial of tai chi exercise for those who have long-term low back pain, which will inform best practice for managing long-term low back pain in clinical settings.
Trial website
none
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28612 0
Address 28612 0
Country 28612 0
Phone 28612 0
Fax 28612 0
Email 28612 0
Contact person for public queries
Name 11769 0
Amanda Hall
Address 11769 0
The George Institute for International Health
Musculoskeletal Division
Level 7, 341 George St.
Sydney, NSW
2000
Country 11769 0
Australia
Phone 11769 0
+61 2 9657 0391
Fax 11769 0
+61 2 9657 0301
Email 11769 0
[email protected]
Contact person for scientific queries
Name 2697 0
Professor Chris Maher
Address 2697 0
The George Institute for Internaltional Health
Musculoskeletal Division
Level 7, 341 George St.
Sydney, NSW
2000
Country 2697 0
Australia
Phone 2697 0
+61 2 9657 0382
Fax 2697 0
+61 2 9657 0301
Email 2697 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

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