- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01123226
Trigger Point Therapy Versus Manipulation Correcting Thoracic Manipulable Lesion
May 13, 2010 updated by: Anglo-European College of Chiropractic
Relative Effectiveness of Trigger Point Therapy Compared to Spinal Manipulation in Correcting a Thoracic Spinal Manipulable Lesion in Subjects With Mechanical Thoracic Back Pain: a Randomised Trial
There will be no difference between trigger point therapy and spinal manipulation in correcting a spine joint dysfunction in the back
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hugh A Gemmell, DC, EdD
- Phone Number: 268 44 1202436200
- Email: hgemmell@aecc.ac.uk
Study Locations
-
-
Dorset
-
Bournemouth, Dorset, United Kingdom, BH5 2DF
- Anglo-European College of Chiropractic
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Contact:
- Hugh A Gemmell, DC, EdD
- Email: hgemmell@aecc.ac.uk
-
Sub-Investigator:
- Jacqueline Richards, MChiro
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- mechanical thoracic back pain
- age 18-64
- presence of at least one spinal manipulable lesion
- presence of a trigger point associated with the spinal manipulable lesion
- able to lie prone on a treatment table for 15 minutes
Exclusion Criteria:
- absolute contraindications to spinal manipulation
- specific thoracic back pain
- bleeding diathesis, use of anticoagulants, long-term corticosteroid use
- involved in litigation for thoracic back pain
- inability to read or write English fluently
- treatment with manipulation or myofascial therapy within past three days
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diversified HVLA spinal manipulation
|
A maximum of two high velocity low amplitude spinal manipulations to one dysfunctional spine joint
|
Active Comparator: Trigger point pressure release
|
The thumb will apply firm pressure to a trigger point in the paravertebral multifidus and rotatores muscles associated with the spine joint dysfunction using the barrier approach.
This will be held until the barrier releases and this will continue until the trigger point is inactivated or 3 minutes has passed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correction of spinal manipulable lesion
Time Frame: Immediate effect of one treatment
|
Dichotomous data either lesion is corrected or not.
|
Immediate effect of one treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pressure pain threshold over the involved spinous process
Time Frame: Immediate effect of one treatment
|
The point at which sensation changes from that of pressure to pain is measured in Kg/cm2
|
Immediate effect of one treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Anticipated)
June 1, 2011
Study Completion (Anticipated)
June 1, 2011
Study Registration Dates
First Submitted
May 13, 2010
First Submitted That Met QC Criteria
May 13, 2010
First Posted (Estimate)
May 14, 2010
Study Record Updates
Last Update Posted (Estimate)
May 14, 2010
Last Update Submitted That Met QC Criteria
May 13, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- AECC05052010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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