Trigger PointsNCT02609412
Immediate Effects of Self-myofascial Release on Latent Trigger Point Sensitivity
A study testing Static compression of LMTRP and Dynamic self-myofascial release of calf in people with Trigger Points, run by Goethe University at 1 site in Germany.
Trial summary
Latent myofascial trigger points (LMTRP) which impair neuromuscular performance occur in both, patients and asymptomatic subjects. As evidence suggests that LMTRP can transform into active trigger points, therapy seems warranted. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigger Points
- What is being tested?
- Static compression of LMTRP and Dynamic self-myofascial release of calf
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to May 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least one diagnosed latent myofascial trigger point in the calf
- age 18 to 65 years
- written informed consent
Who cannot join
- active myofascial trigger point in the calf
- regular intake of drugs or within past 48 hours
- severe psychiatric, neurological, orthopaedic, cardiovascular or endocrine diseases
- pregnancy or nursing period
- any condition that negatively influences current quality of life
Trial locations and contacts
1 site in 1 country.
About this study
Latent myofascial trigger points (LMTRP) which impair neuromuscular performance occur in both, patients and asymptomatic subjects. As evidence suggests that LMTRP can transform into active trigger points, therapy seems warranted. Besides other modalities, self-massage using foam rollers (self-myofascial release) has been applied as a treatment. However, there is no data on the efficacy of this method concerning LMTRP. Thus, the present study aims to evaluate the effects of different forms of self-myofascial release on LMTRP pain.
Healthy patients with LMTRP in the calf are randomly allocated to one of three groups: 1) 90s static compression of the most sensitive LMTRP by means of the foam roll, 2) dynamic self-myofascial release rolling back and forth on the calf muscles for 90s using a foam roller, 3) placebo laser acupuncture of the most sensitive LMTRP. All subjects participate in a familiarization session with the foam roller one week prior to treatments. As an outcome, pressure pain threshold is assessed with an algometer. The investigators hypothesize, that static compression can reduce pressure pain of LMTRP more effective than dynamic self-myofascial release. The investigators further expect that placebo treatment will be the least effective method.
- Conditions
- Trigger Points
- Being tested
- Static compression of LMTRP, Dynamic self-myofascial release of calf, Placebo laser acupuncture of LMTRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static compression of LMTRPOther
Static compression of most sensitive Triggerpoint with a foam roller (Blackroll Inc., Germany).
Dynamic self-myofascial release of calfOther
Dynamic self-massage of the calf with a foam roller (Blackroll Inc., Germany).
Placebo laser acupuncture of LMTRPDevice
Used device: Laserneedle System (Laserneedle Systems GmbH, Glienicke/Nordbahn, Germany). Electrodes positioned on skin but device remains switched off.
| Study group | Role | What they receive |
|---|---|---|
| Static compression of LMTRP | Experimental | static compression of most sensitive LMTRP with the foam roll for 90 seconds Receives: Other: Static compression of LMTRP |
| Dynamic self-myofascial release of calf | Experimental | dynamic self-myofascial release rolling back and forth on the entire calf for 90 seconds with the foam roll Receives: Other: Dynamic self-myofascial release of calf |
| Placebo laser acupuncture of LMTRP | Placebo comparator | placebo laser acupuncture applied on most sensitive LMTRP of the calf, light and acoustic sounds provided, but laser remains switched off, 90 seconds Receives: Device: Placebo laser acupuncture of LMTRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pressure pain threshold [kg/cm²] assessed by pressure algometer
Measured: Baseline (M1) - 3 minutes (M2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger PointsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Dr. Winfried Banzer, Goethe University
- Investigators
- Winfried Banzer, MD, PhD, Principal investigator, Department of Sports Medicine, Goethe University Frankfurt/Main
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609412
- Sponsor's protocol ID
- SpM2015-002
- Status last verified
- May 2016
- First submitted
- 2 Oct 2015
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Self-myofascial Release on Latent Trigger Point Sensitivity
- ClinicalTrials.gov ID
- NCT02609412
- Acronym / sponsor ID
- SpM2015-002
- Conditions
- Trigger Points
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 20 Nov 2015 (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.
Latent myofascial trigger points (LMTRP) which impair neuromuscular performance occur in both, patients and asymptomatic subjects. As evidence suggests that LMTRP can transform into active trigger points, therapy seems warranted. Besides other modalities, self-massage using foam rollers (self-myofascial release) has been applied as a treatment. However, there is no data on the efficacy of this method concerning LMTRP. Thus, the present study aims to evaluate the effects of different forms of self-myofascial release on LMTRP pain.
Healthy patients with LMTRP in the calf are randomly allocated to one of three groups: 1) 90s static compression of the most sensitive LMTRP by means of the foam roll, 2) dynamic self-myofascial release rolling back and forth on the calf muscles for 90s using a foam roller, 3) placebo laser acupuncture of the most sensitive LMTRP. All subjects participate in a familiarization session with the foam roller one week prior to treatments. As an outcome, pressure pain threshold is assessed with an algometer. The investigators hypothesize, that static compression can reduce pressure pain of LMTRP more effective than dynamic self-myofascial release. The investigators further expect that placebo treatment will be the least effective method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Static compression of LMTRP | Experimental | Other: Static compression of LMTRPstatic compression of most sensitive LMTRP with the foam roll for 90 seconds |
| Dynamic self-myofascial release of calf | Experimental | Other: Dynamic self-myofascial release of calfdynamic self-myofascial release rolling back and forth on the entire calf for 90 seconds with the foam roll |
| Placebo laser acupuncture of LMTRP | Placebo comparator | Device: Placebo laser acupuncture of LMTRPplacebo laser acupuncture applied on most sensitive LMTRP of the calf, light and acoustic sounds provided, but laser remains switched off, 90 seconds |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least one diagnosed latent myofascial trigger point in the calf
- age 18 to 65 years
- written informed consent
Key exclusion criteria (5 listed)
- active myofascial trigger point in the calf
- regular intake of drugs or within past 48 hours
- severe psychiatric, neurological, orthopaedic, cardiovascular or endocrine diseases
- pregnancy or nursing period
- any condition that negatively influences current quality of life
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 |
|---|---|---|
| Static compression of LMTRPStatic compression of most sensitive Triggerpoint with a foam roller (Blackroll Inc., Germany). | Other | Static compression of LMTRP |
| Dynamic self-myofascial release of calfDynamic self-massage of the calf with a foam roller (Blackroll Inc., Germany). | Other | Dynamic self-myofascial release of calf |
| Placebo laser acupuncture of LMTRPUsed device: Laserneedle System (Laserneedle Systems GmbH, Glienicke/Nordbahn, Germany). Electrodes positioned on skin but device remains switched off. | Device | Placebo laser acupuncture of LMTRP |
Primary outcome
Change in pressure pain threshold [kg/cm²] assessed by pressure algometer
Time frame: Baseline (M1) - 3 minutes (M2)
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 11 May 2016.
Related trials for Trigger Points
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
Recruiting
Comparing Myofascial Exercise and Trigger Point Therapy for Non-Specific Low Back Pain
Non-specific Low Back Pain
Not yet recruiting
Trigger Point Injection and Myofascial Release for Cervicogenic Headache
Cervicogenic Headache
Recruiting
Myo-Electrical and Nerve Root Function Response to Focused Extracorpeal Shock Wave in Cervical Radiculopathy
Cervical Radiculopathy
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
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.
Winfried Banzer, MD, PhD principal investigator
Department of Sports Medicine, Goethe University Frankfurt/Main
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static compression of LMTRP and Dynamic self-myofascial release of calf in people with Trigger Points, run by Goethe University at 1 site in Germany.
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 5 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 11 May 2016. 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 Germany. 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?
Change in pressure pain threshold [kg/cm²] assessed by pressure algometer (time frame: Baseline (M1) - 3 minutes (M2)). 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 11 May 2016.