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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02609412
Other study ID # SpM2015-002
Secondary ID
Status Completed
Phase N/A
First received October 2, 2015
Last updated May 10, 2016
Start date May 2015
Est. completion date May 2016

Study information

Verified date May 2016
Source Goethe University
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Static compression of LMTRP
Static compression of most sensitive Triggerpoint with a foam roller (Blackroll Inc., Germany).
Dynamic self-myofascial release of calf
Dynamic self-massage of the calf with a foam roller (Blackroll Inc., Germany).
Device:
Placebo laser acupuncture of LMTRP
Used device: Laserneedle System (Laserneedle Systems GmbH, Glienicke/Nordbahn, Germany). Electrodes positioned on skin but device remains switched off.

Locations

Country Name City State
Germany Goethe University Frankfurt/Main Frankfurt/Main

Sponsors (1)

Lead Sponsor Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in pressure pain threshold [kg/cm²] assessed by pressure algometer Baseline (M1) - 3 minutes (M2) No
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