Myofascial Pain SyndromeNCT01167036
Effectiveness of a Massage Instrument Compared to Placebo for Upper Trapezius Muscle Pain
A study testing FascialEdge instrument in people with Myofascial Pain Syndrome, run by Anglo-European College of Chiropractic at 1 site in United Kingdom.
Trial summary
The purpose of this study was to determine if using a specialized massage tool was more effective than a placebo treatment in relieving pain in the upper trapezius muscle along the top of the shoulder. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- FascialEdge instrument
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Jan 2010
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- male or female
- between 18-64 years of age
- a latent trigger point of the upper trapezius muscle
Who cannot join
- an active trigger point of the upper trapezius muscle
- rash or infection of the skin over the trigger point
- neck pain
- taking anticoagulant drugs
- spontaneous bleeding
- long term corticosteroid use
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Anglo-European College of Chiropractic
Bournemouth, Dorset, BH5 2DF
About this study
Official title: Immediate Effectiveness of Instrument Assisted Soft Tissue Mobilization Compared to Placebo on the Sensitivity of Latent Upper Trapezius Trigger Points: A Randomized Double Blind, Placebo-controlled, Parallel-group Study
The purpose of this study was to determine if using a specialized massage tool was more effective than a placebo treatment in relieving pain in the upper trapezius muscle along the top of the shoulder.
Read the detailed description
The purpose of the study was to determine if a statistically significant and clinically meaningful difference exits between the FascialEdge tool and placebo in the treatment of latent upper trapezius trigger points.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- FascialEdge instrument, Placebo electric point stimulation
- Keywords
- Myofascial pain syndrome, Trigger points, Myofascial, Chiropractic, Massage, Musculoskeletal manipulation
- 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.
FascialEdge instrumentDevice
Also called FascialEdge tool
Stroking massage to patient tolerance over the muscle
Placebo electric point stimulationOther
Also called Pointer Plus stimulator
Detuned electric point stimulation over the involved muscle
| Study group | Role | What they receive |
|---|---|---|
| FascialEdge tool | Experimental | A massage tool used to loosen adhesions in the superficial fascia Receives: Device: FascialEdge instrument |
| Placebo | Placebo comparator | Detuned electric point stimulation over the upper trapezius trigger point Receives: Other: Placebo electric point stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold over the upper trapezius muscles as determined with a pressure pain algometer
Measured: Within five minutes after initial and only treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startSep 2009
- Primary completionJan 2010
- Study completionJan 2010
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
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
- NCT01167036
- Sponsor's protocol ID
- AECC 20091
- Status last verified
- Aug 2009
- First submitted
- 20 Jul 2010
- Last updated
- 22 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effectiveness of Instrument Assisted Soft Tissue Mobilization Compared to Placebo on the Sensitivity of Latent Upper Trapezius Trigger Points: A Randomized Double Blind, Placebo-controlled, Parallel-group Study
- ClinicalTrials.gov ID
- NCT01167036
- Acronym / sponsor ID
- AECC 20091
- Conditions
- Myofascial Pain Syndrome
- Keywords
- Myofascial pain syndrome, Trigger points, Myofascial, Chiropractic, Massage, Musculoskeletal manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Anglo-European College of ChiropracticUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 22 Jul 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 purpose of this study was to determine if using a specialized massage tool was more effective than a placebo treatment in relieving pain in the upper trapezius muscle along the top of the shoulder.
Detailed description
The purpose of the study was to determine if a statistically significant and clinically meaningful difference exits between the FascialEdge tool and placebo in the treatment of latent upper trapezius trigger points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FascialEdge tool | Experimental | Device: FascialEdge instrumentA massage tool used to loosen adhesions in the superficial fascia |
| Placebo | Placebo comparator | Other: Placebo electric point stimulationDetuned electric point stimulation over the upper trapezius trigger point |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male or female
- between 18-64 years of age
- a latent trigger point of the upper trapezius muscle
Key exclusion criteria (6 listed)
- an active trigger point of the upper trapezius muscle
- rash or infection of the skin over the trigger point
- neck pain
- taking anticoagulant drugs
- spontaneous bleeding
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 |
|---|---|---|
| FascialEdge instrumentAlso: FascialEdge toolStroking massage to patient tolerance over the muscle | Device | FascialEdge tool |
| Placebo electric point stimulationAlso: Pointer Plus stimulatorDetuned electric point stimulation over the involved muscle | Other | Placebo |
Primary outcome
Pressure pain threshold over the upper trapezius muscles as determined with a pressure pain algometer
Time frame: Within five minutes after initial and only treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2010.
Related trials for Myofascial Pain Syndrome
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Not yet recruiting
Effects of IASTM, Deep Friction Massage, and Sham Instrument-Assisted Soft Tissue Mobilization on Electromyographical Activation, Pain and Function in Non-Specific Low Back Pain
Low Back Pain, Trigger Point Pain, Myofascial
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FascialEdge instrument in people with Myofascial Pain Syndrome, 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 3 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: finished, as of the sponsor's last update on 22 Jul 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threshold over the upper trapezius muscles as determined with a pressure pain algometer (time frame: Within five minutes after initial and only 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 22 Jul 2010.