Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000299404
Ethics application status
Approved
Date submitted
1/06/2007
Date registered
5/06/2007
Date last updated
5/06/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of stretching in patients with persisting pain - a randomised controlled trial
Scientific title
The effects of stretching in patients with persisting pain - a randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persisting pain (greater than 3 months) 1841 0
Condition category
Condition code
Other 1935 1935 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The two legs of each subject are randomised into either the treatment or control condition.

Intervention: The hamstring muscles of the treatment leg will be stretched for 1 minute per day for three weeks.
Intervention code [1] 1801 0
Treatment: Other
Comparator / control treatment
Control Condition: Meanwhile, the hamstring muscles of the control leg will receive no specific stretch intervention during the three-week period.
Control group
Active

Outcomes
Primary outcome [1] 2750 0
Mean change in passive hip flexion angle with standardised torque to measure hamstring muscle extensibility
Timepoint [1] 2750 0
At baseline and at the end of the 3-week stretching program (24 hours after the last stretch treatment)
Primary outcome [2] 2751 0
Mean change in passive hip flexion angle at the highest tolerated torque to measure stretch tolerance
Timepoint [2] 2751 0
At baseline and at the end of the 3-week stretch program (24 hours after the last stretch treatment)
Primary outcome [3] 2752 0
Mean change in pain intensity as reported on the 10-point numerical rating scale
Timepoint [3] 2752 0
At baseline and at the end of the 3-week stretch program (24 hours after the last stretch treatment)
Secondary outcome [1] 4642 0
N/A
Timepoint [1] 4642 0

Eligibility
Key inclusion criteria
Pain persisting for greater than three months, no further medical or surgical investigations or treatments planned, not requiring urgent psychiatric treatment, no primary drug or alcohol problem, inextensible hamstring muscles as tested using a standard "toe-touch" test.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to tolerate testing.

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)
A concealed allocation schedule was used. Allocation involved the supervising physiotherapist contacting the holder of the allocation schedule, who was located at an "off-site" centre.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was achieved by using a randomisation table created by a computer software (computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The assessor and data analyst are blinded to treatment allocation. The subjects and supervising therapist were unable to be blinded due to the design of the intervention.
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2079 0
Hospital
Name [1] 2079 0
Royal North Shore Hospital
Country [1] 2079 0
Australia
Primary sponsor type
Individual
Name
Roberta Law
Address
Country
Secondary sponsor category [1] 1884 0
Individual
Name [1] 1884 0
Lisa Harvey,
Address [1] 1884 0
Country [1] 1884 0
Secondary sponsor category [2] 1885 0
Individual
Name [2] 1885 0
Damien Finniss
Address [2] 1885 0
Country [2] 1885 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3869 0
Royal North Shore Hospital by the Northern Sydney Central Coast HREC
Ethics committee address [1] 3869 0
Ethics committee country [1] 3869 0
Australia
Date submitted for ethics approval [1] 3869 0
Approval date [1] 3869 0
29/01/2007
Ethics approval number [1] 3869 0
Protocol 0603-035M (SP)
Ethics committee name [2] 3870 0
RNSH by the University of Sydney HREC
Ethics committee address [2] 3870 0
Ethics committee country [2] 3870 0
Australia
Date submitted for ethics approval [2] 3870 0
Approval date [2] 3870 0
12/03/2007
Ethics approval number [2] 3870 0
9947

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

Contacts
Principal investigator
Name 27904 0
Address 27904 0
Country 27904 0
Phone 27904 0
Fax 27904 0
Email 27904 0
Contact person for public queries
Name 10990 0
Roberta Law
Address 10990 0
Physiotherapy Department
Royal North Shore Hospital
St Leonards NSW 2065
Sydney
Country 10990 0
Australia
Phone 10990 0
(02) 9926 7556
Fax 10990 0
(02) 9926 7365
Email 10990 0
[email protected]
Contact person for scientific queries
Name 1918 0
Roberta Law
Address 1918 0
Physiotherapy Department
Royal North Shore Hospital
St Leonards NSW 2065
Country 1918 0
Australia
Phone 1918 0
(02) 9926 7556
Fax 1918 0
(02) 9926 7365
Email 1918 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.