Spinal Manipulable LesionPhase 2NCT01123226
Trigger Point Therapy Versus Manipulation Correcting Thoracic Manipulable Lesion
A Phase 2 study testing spinal manipulation and trigger point therapy in people with Spinal Manipulable Lesion and Somatic Dysfunction, run by Anglo-European College of Chiropractic at 1 site in United Kingdom.
Trial summary
There will be no difference between trigger point therapy and spinal manipulation in correcting a spine joint dysfunction in the back Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Spinal Manipulable Lesion, Somatic Dysfunction
- What is being tested?
- spinal manipulation and trigger point therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Anglo-European College of Chiropractic
Bournemouth, Dorset, BH5 2DF
Hugh A Gemmell, DC, EdD, hgemmell@aecc.ac.uk
Jacqueline Richards, MChiro
About this study
Official title: 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
- Conditions
- Spinal Manipulable Lesion, Somatic Dysfunction
- Being tested
- spinal manipulation, trigger point therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal manipulationProcedure or surgery
A maximum of two high velocity low amplitude spinal manipulations to one dysfunctional spine joint
trigger point therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Diversified HVLA spinal manipulation | Experimental | Not described Receives: Procedure: spinal manipulation |
| Trigger point pressure release | Active comparator | Not described Receives: Procedure: trigger point therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correction of spinal manipulable lesion
Dichotomous data either lesion is corrected or not.
Measured: Immediate effect of one treatment
Secondary outcomes (1)
Change in pressure pain threshold over the involved spinous process
The point at which sensation changes from that of pressure to pain is measured in Kg/cm2
Measured: Immediate effect of one treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Manipulable LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anglo-European College of Chiropractic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123226
- Sponsor's protocol ID
- AECC05052010
- Status last verified
- May 2010
- First submitted
- 13 May 2010
- Last updated
- 14 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01123226
- Acronym / sponsor ID
- AECC05052010
- Conditions
- Spinal Manipulable Lesion, Somatic Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anglo-European College of ChiropracticUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 14 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There will be no difference between trigger point therapy and spinal manipulation in correcting a spine joint dysfunction in the back
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diversified HVLA spinal manipulation | Experimental | Procedure: spinal manipulation |
| Trigger point pressure release | Active comparator | Procedure: trigger point therapy |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal manipulationA maximum of two high velocity low amplitude spinal manipulations to one dysfunctional spine joint | Procedure or surgery | Diversified HVLA spinal manipulation |
| trigger point therapyThe 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. | Procedure or surgery | Trigger point pressure release |
Primary outcome
Correction of spinal manipulable lesion
Time frame: Immediate effect of one treatment
Dichotomous data either lesion is corrected or not.
1 secondary outcome
Change in pressure pain threshold over the involved spinous process
Time frame: Immediate effect of one treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing spinal manipulation and trigger point therapy in people with Spinal Manipulable Lesion and Somatic Dysfunction, run by Anglo-European College of Chiropractic at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hugh A Gemmell, DC, EdD (44 1202436200 ext. 268, hgemmell@aecc.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correction of spinal manipulable lesion (time frame: Immediate effect of one treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2010.