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Immediate Effects of Self-myofascial Release on Latent Trigger Point Sensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609412
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Dr. Winfried Banzer, Goethe University

Tracking Information
First Submitted Date  ICMJE October 2, 2015
First Posted Date  ICMJE November 20, 2015
Last Update Posted Date May 11, 2016
Study Start Date  ICMJE May 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
Change in pressure pain threshold [kg/cm²] assessed by pressure algometer [ Time Frame: Baseline (M1) - 3 minutes (M2) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immediate Effects of Self-myofascial Release on Latent Trigger Point Sensitivity
Official Title  ICMJE Not Provided
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Trigger Points
Intervention  ICMJE
  • Other: Static compression of LMTRP
    Static compression of most sensitive Triggerpoint with a foam roller (Blackroll Inc., Germany).
  • Other: 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.
Study Arms  ICMJE
  • Experimental: Static compression of LMTRP
    static compression of most sensitive LMTRP with the foam roll for 90 seconds
    Intervention: Other: Static compression of LMTRP
  • 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
    Intervention: Other: Dynamic self-myofascial release of calf
  • 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
    Intervention: Device: Placebo laser acupuncture of LMTRP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2015)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02609412
Other Study ID Numbers  ICMJE SpM2015-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. Dr. Winfried Banzer, Goethe University
Study Sponsor  ICMJE Goethe University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Winfried Banzer, MD, PhD Department of Sports Medicine, Goethe University Frankfurt/Main
PRS Account Goethe University
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP