Myofascial Pain SyndromePhase 1/2NCT01174667
Massage of the Low Back Muscles Assessed With Ultrasound Scanning
A Phase 1/2 study testing Specific massage for fascial release and Quiet non-instructed rest for 3 minutes in people with Myofascial Pain Syndrome, run by Anglo-European College of Chiropractic.
Trial summary
The aim of the study is to use diagnostic ultrasound to compare the thickness of soft tissues in the low back in a group of patients with chronic low back pain treated with massage to a control group of non-treated patients. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Specific massage for fascial release and Quiet non-instructed rest for 3 minutes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Jun 2011
- Phase
- Phase 1/2
- 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
- History of chronic low back pain far at least 3 months
- Able to read and write English
- Between 18-64 years of age
Who cannot join
- Prior lumbar surgery
- Infected or broken skin over the lumbodorsal fascia
- Major structural spinal deformity
- Specific cause of low back pain, such as tumor, infection, fracture
- Bleeding disorders or use of anticoagulant medications
- Pregnancy
- Litigation for low back pain
- Systemic infection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Fascial Release on Connective Tissue Structure in Human Subjects With Chronic Low Back Pain as Determined by Ultrasound Imaging: a Randomized Controlled Trial
The aim of the study is to use diagnostic ultrasound to compare the thickness of soft tissues in the low back in a group of patients with chronic low back pain treated with massage to a control group of non-treated patients.
It is hypothesized that on average, soft tissue thickness in the lumbar region will change in the group receiving massage compared to the control group.
Read the detailed description
A specialized form of massage designed to reduce fascial restrictions will be compared to a no-treatment control group based on a change in thickness of the lumbodorsal fascia as determined by ultrasound imaging.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- Specific massage for fascial release, Quiet non-instructed rest for 3 minutes
- Keywords
- Myofascial pain, Trigger points
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific massage for fascial releaseProcedure or surgery
Also called Superficial fascial release
Patient will receive a 3 minute massage to reduce restrictions in the lumbodorsal fascia.
Quiet non-instructed rest for 3 minutesOther
Also called Uninstructed rest
Patient will lay quietly without any instructions on how to relax.
| Study group | Role | What they receive |
|---|---|---|
| Fascial massage | Experimental | A specific type of fascial massage to release restricted lumbodorsal fascia. Receives: Procedure: Specific massage for fascial release |
| No treatment control | No intervention | Patient will rest quietly without receiving any instruction. Receives: Other: Quiet non-instructed rest for 3 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of lumbodorsal fascia determined by ultrasound imaging
Measured: An average of 5 minutes from the the end of first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 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 Myofascial Pain SyndromeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anglo-European College of Chiropractic
- Sponsor type
- University, hospital or other
- Investigators
- Hugh Gemmell, DC, EdD, Principal investigator, Anglo-European College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174667
- Sponsor's protocol ID
- AECC 290710
- Status last verified
- Jul 2010
- First submitted
- 2 Aug 2010
- Last updated
- 4 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fascial Release on Connective Tissue Structure in Human Subjects With Chronic Low Back Pain as Determined by Ultrasound Imaging: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01174667
- Acronym / sponsor ID
- AECC 290710
- Conditions
- Myofascial Pain Syndrome
- Keywords
- Myofascial pain, Trigger points
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 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
- 4 Aug 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.
The aim of the study is to use diagnostic ultrasound to compare the thickness of soft tissues in the low back in a group of patients with chronic low back pain treated with massage to a control group of non-treated patients.
It is hypothesized that on average, soft tissue thickness in the lumbar region will change in the group receiving massage compared to the control group.
Detailed description
A specialized form of massage designed to reduce fascial restrictions will be compared to a no-treatment control group based on a change in thickness of the lumbodorsal fascia as determined by ultrasound imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascial massage | Experimental | Procedure: Specific massage for fascial releaseA specific type of fascial massage to release restricted lumbodorsal fascia. |
| No treatment control | No intervention | Other: Quiet non-instructed rest for 3 minutesPatient will rest quietly without receiving any instruction. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- History of chronic low back pain far at least 3 months
- Able to read and write English
- Between 18-64 years of age
Key exclusion criteria (8 listed)
- Prior lumbar surgery
- Infected or broken skin over the lumbodorsal fascia
- Major structural spinal deformity
- Specific cause of low back pain, such as tumor, infection, fracture
- Bleeding disorders or use of anticoagulant medications
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 |
|---|---|---|
| Specific massage for fascial releaseAlso: Superficial fascial releasePatient will receive a 3 minute massage to reduce restrictions in the lumbodorsal fascia. | Procedure or surgery | Fascial massage |
| Quiet non-instructed rest for 3 minutesAlso: Uninstructed restPatient will lay quietly without any instructions on how to relax. | Other | No treatment control |
Primary outcome
Thickness of lumbodorsal fascia determined by ultrasound imaging
Time frame: An average of 5 minutes from the the end of first treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2010.
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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.
Hugh Gemmell, DC, EdD principal investigator
Anglo-European College of Chiropractic
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Specific massage for fascial release and Quiet non-instructed rest for 3 minutes in people with Myofascial Pain Syndrome, run by Anglo-European College of Chiropractic.
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 3 inclusion and 8 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 4 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Gemmell, DC, EdD (441202436268 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?
Thickness of lumbodorsal fascia determined by ultrasound imaging (time frame: An average of 5 minutes from the the end of first 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 4 Aug 2010.