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Trial registered on ANZCTR


Registration number
ACTRN12612000426886
Ethics application status
Approved
Date submitted
13/04/2012
Date registered
16/04/2012
Date last updated
28/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of Strain-Counterstrain
treatment for people with neck pain selected using a
treatment based classification system
Scientific title
A randomised controlled trial of Strain-Counterstrain
treatment for people with neck pain selected using a
treatment based classification system with the Neck Disability Index as primary outcome measure
Secondary ID [1] 280321 0
Nil
Universal Trial Number (UTN)
U111-1129-9316
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-specific acute neck pain 286285 0
Condition category
Condition code
Musculoskeletal 286517 286517 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Strain-Counterstrain treatment treatment will involve passive positioning of the participant, with varying degrees of cervical flexion/extension, lateral flexion and rotation, such that there is a two-thirds reduction in tenderness at a monitored digitally tender point (Jones et al 1995). This is to be determined by having participants rate their tenderness to palpation at digitally tender points on a numerical pain scale where 10 represented initial tenderness and 0 no tenderness. In addition to reported tenderness with intermittent digital probing, perceived tissue tension will be used to guide the experimenter to the appropriate passive position (Jones et al 1995). The participant will be passively maintained at this point by the experimenter for approximately 90 seconds, with intermittent digital probing at 30-sec intervals to ensure correct positioning, before being slowly and passively returned to a neutral position (Jones et al 1995, Kusunose and Wendorff 1990, Kusunose 1993). Treatment using a digitally tender point will be considered successful if tenderness is reduced by 70% or more (3/10 or less with digital probing) (Kusunose 1993, Kusunose and Wendorff 1990), however the intention will be to reduce tenderness to a numerical pain rating of 1/10 or less with digital probing. This treatment is to be provided in two half hour sessions in a one week period.
Intervention code [1] 284675 0
Treatment: Other
Comparator / control treatment
Placebo Strain-Counterstrain treatment is to be the same as Strain-Counterstrain treatment except, that once the appropriate passive position is reached, the participant will be passively, deliberately and significantly moved out of this position. Intermittent digital probing of the digital tender point will not be performed since this has been shown to significantly reduce tenderness at digitally tender points identified using Strain-Counterstrain procedures (Lewis et al 2010). This intervention is to be provided in two half hour sessions in a one week period.
Control group
Placebo

Outcomes
Primary outcome [1] 286947 0
Neck Disability Index
Timepoint [1] 286947 0
Initial assessment, 1 week, 6 weeks, 6 months
Secondary outcome [1] 297040 0
SF-36 health questionnaire
Timepoint [1] 297040 0
Initial assessment, 1 week, 6 weeks, 6 months
Secondary outcome [2] 297041 0
Visual analogue scale for pain rating
Timepoint [2] 297041 0
Initial assessment, 1 week, 6 weeks, 6 months
Secondary outcome [3] 297042 0
Global rating of change
Timepoint [3] 297042 0
1 week
Secondary outcome [4] 297043 0
Fear avoidance beliefs questionnaire
Timepoint [4] 297043 0
Initial assessment

Eligibility
Key inclusion criteria
1) Neck pain (Merskey and Bogduk 1994) of less than 30 days duration
2) Between 18 and 60 years
3) Initial VAS pain rating less than 7/10
4) Initial neck disability index score between 20 and 52
5) Able to lie supine for 10 minutes
6) Displaying a minimum of four digitally tender points at examined sites (Kusunose and Wendorff 1990) at their initial assessment.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Whiplash mechanism of injury
2) Signs of nerve root compression
3) Symptoms distal to the elbow
4) Chief complaint of headaches with neck pain

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)
Participants will be referred by public and private medical practitioners for treatment of neck pain or will be recruited through posted notices and advertisement in local papers. Randomised group allocation will be achieved by consecutively- numbered sealed opaque envelopes containing randomly generated numbers, prepared by an independent investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer is to be used to provide randomly generated numbers. These will be placed in consecutively numbered envelopes.
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
20/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
85
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285094 0
Self funded/Unfunded
Name [1] 285094 0
Cynan Lewis
Country [1] 285094 0
Australia
Primary sponsor type
Hospital
Name
Stanthorpe Health Services
Address
8 McGregor Terrace
Stanthorpe
Qld 4380
Country
Australia
Secondary sponsor category [1] 283954 0
None
Name [1] 283954 0
Address [1] 283954 0
Country [1] 283954 0
Other collaborator category [1] 260732 0
Individual
Name [1] 260732 0
Professor Michele Sterling
Address [1] 260732 0
Edith Cavell Building
RBWH
Herston
Qld 4209
Country [1] 260732 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287105 0
HREC Darling Downs Hospital and Health Service
Ethics committee address [1] 287105 0
HREC Coordinator
The Undercroft
Mount Lofty Heights Nursing Home
Cnr Stuart St and Rifle Range Road
MOUNT LOFTY QLD 4350
Ethics committee country [1] 287105 0
Australia
Date submitted for ethics approval [1] 287105 0
10/05/2012
Approval date [1] 287105 0
25/07/2012
Ethics approval number [1] 287105 0
(EC00182)

Summary
Brief summary
Question: Is Strain-Counterstrain treatment (manual therapy treatment using passive positioning) more effective than sham Strain-Counterstrain intervention in reducing levels of pain and disability in people with neck pain selected using a treatment-based classification system? Design: Randomised trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Participants: 85 participants (male and female) between 18 and 60 years experiencing non-specific neck pain for less than 30 days. Intervention: Participants are to attend two treatments in a week. The experimental group is to receive Strain-Counterstrain treatment and the control group sham Strain-Counterstrain intervention. Following the initial intervention period, participants are to receive standard Physiotherapy treatment for neck pain for up to 6 weeks. Outcome measures: The primary outcome is to be the Neck disability questionnaire, measured at 1 week (ie, end of initial intervention), 6 weeks, and 28 weeks. Secondary outcome measures are to include the Fear avoidance beliefs questionnaire, SF-36, visual analogue scale pain ratings and a 7-point global rating of change.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34062 0
Address 34062 0
Country 34062 0
Phone 34062 0
Fax 34062 0
Email 34062 0
Contact person for public queries
Name 17309 0
Cynan Lewis
Address 17309 0
PO Box 273
Stanthorpe
Qld 4380
Country 17309 0
Australia
Phone 17309 0
+61 7 46815250
Fax 17309 0
Email 17309 0
[email protected]
Contact person for scientific queries
Name 8237 0
Cynan Lewis
Address 8237 0
PO Box 273
Stanthorpe
Qld 4380
Country 8237 0
Australia
Phone 8237 0
+61 7 46815250
Fax 8237 0
Email 8237 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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