- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02609412
Immediate Effects of Self-myofascial Release on Latent Trigger Point Sensitivity
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Frankfurt/Main, Germany, 60488
- Goethe University Frankfurt/Main
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- at least one diagnosed latent myofascial trigger point in the calf
- age 18 to 65 years
- written informed consent
Exclusion Criteria:
- 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
Study Plan
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: Static compression of LMTRP
static compression of most sensitive LMTRP with the foam roll for 90 seconds
|
Static compression of most sensitive Triggerpoint with a foam roller (Blackroll Inc., Germany).
|
|
Experimental: Dynamic self-myofascial release of calf
dynamic self-myofascial release rolling back and forth on the entire calf for 90 seconds with the foam roll
|
Dynamic self-massage of the calf with a foam roller (Blackroll Inc., Germany).
|
|
Placebo Comparator: Placebo laser acupuncture of LMTRP
placebo laser acupuncture applied on most sensitive LMTRP of the calf, light and acoustic sounds provided, but laser remains switched off, 90 seconds
|
Used device: Laserneedle System (Laserneedle Systems GmbH, Glienicke/Nordbahn, Germany).
Electrodes positioned on skin but device remains switched off.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in pressure pain threshold [kg/cm²] assessed by pressure algometer
Time Frame: Baseline (M1) - 3 minutes (M2)
|
Baseline (M1) - 3 minutes (M2)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Winfried Banzer, MD, PhD, Department of Sports Medicine, Goethe University Frankfurt/Main
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SpM2015-002
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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