NCT02609412

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

October 2, 2015

Last Update Submit

May 10, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in pressure pain threshold [kg/cm²] assessed by pressure algometer

    Baseline (M1) - 3 minutes (M2)

Study Arms (3)

Static compression of LMTRP

EXPERIMENTAL

static compression of most sensitive LMTRP with the foam roll for 90 seconds

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

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

Device: Placebo laser acupuncture of LMTRP

Interventions

Static compression of most sensitive Triggerpoint with a foam roller (Blackroll Inc., Germany).

Static compression of LMTRP

Dynamic self-massage of the calf with a foam roller (Blackroll Inc., Germany).

Dynamic self-myofascial release of calf

Used device: Laserneedle System (Laserneedle Systems GmbH, Glienicke/Nordbahn, Germany). Electrodes positioned on skin but device remains switched off.

Placebo laser acupuncture of LMTRP

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least one diagnosed latent myofascial trigger point in the calf
  • age 18 to 65 years
  • written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goethe University Frankfurt/Main

Frankfurt am Main, 60488, Germany

Location

Study Officials

  • Winfried Banzer, MD, PhD

    Department of Sports Medicine, Goethe University Frankfurt/Main

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

October 2, 2015

First Posted

November 20, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 11, 2016

Record last verified: 2016-05

Locations