NCT02564081

Brief Summary

Recent research suggests that the skeletal muscles and the fibrous connective tissue form a body-wide network of myofascial chains. A systematic analysis of dissection studies suggests that fascia links at least a variety of muscles to myofascial chains (Wilke et al. 2015). As fascia can modify its stiffness, strain transmission along these meridians is supposable (Norton-Old et al. 2013). Tensile transmission along myofascial chains might contribute to the proper functioning of the movement system. However, despite solid evidence from in vitro studies, scarce data is available concerning the in vivo behavior of the meridians. The present study is conducted to resolve this research deficit and to elucidate whether stretching of the lower limb muscles increases neck mobility. Healthy subjects (n = 3 x 20) participate in the randomized controlled trial. One group performs three 30 s bouts of static stretching for the gastrocnemius and the hamstrings respectively. A control group remains inactive for the same time. Participants of the third group perform 6x30 s bouts of static stretching of the cervical spine in zhe sagittal plane (flexion only). Pre and post intervention as well as 5 min after the intervention, maximal cervical range of motion (ROM) in flexion/extension, lateral flexion and rotation was assessed using an ultrasonic movement analysis system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 2, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

September 29, 2015

Last Update Submit

February 1, 2016

Conditions

FasciaRandomized Controlled TrialStretchingMyofascial

Outcome Measures

Primary Outcomes (1)

  • Maximal cervical range of motion in flexion/extension

    2 min.

Secondary Outcomes (2)

  • Maximal cervical range of motion in lateral flexion

    2 min.

  • Maximal cervical range of motion in rotation

    2 min.

Study Arms (3)

Static Stretching lower limb

EXPERIMENTAL

Three 30 s bouts of static stretching for the gastrocnemius and the hamstrings respectively

Other: Static Stretching lower limb

Static stretching Cervical

ACTIVE COMPARATOR

Six 30 s bouts of static stretching of the cervical spine in the sagittal plane (flexion only)

Other: Static stretching Cervical

Ctrl

NO INTERVENTION

No intervention

Interventions

Static Stretching lower limbOTHER
Static Stretching lower limb
Static stretching CervicalOTHER
Static stretching Cervical

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy participants after subscribing informed consent

You may not qualify if:

  • severe orthopedic, cardiovascular, neurological, psychiatric or endocrine diseases, not completely healed traumata, drug intake in the past 48 hours, pregnancy and presence of muscle soreness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Sports Medicine, Goethe University Frankfurt/Main

Frankfurt am Main, Hesse, 60487, Germany

Location

Related Publications (2)

  • Wilke J, Krause F, Vogt L, Banzer W. What Is Evidence-Based About Myofascial Chains: A Systematic Review. Arch Phys Med Rehabil. 2016 Mar;97(3):454-61. doi: 10.1016/j.apmr.2015.07.023. Epub 2015 Aug 14.

    PMID: 26281953BACKGROUND

  • Norton-Old KJ, Schache AG, Barker PJ, Clark RA, Harrison SM, Briggs CA. Anatomical and mechanical relationship between the proximal attachment of adductor longus and the distal rectus sheath. Clin Anat. 2013 May;26(4):522-30. doi: 10.1002/ca.22116. Epub 2012 Jun 14.

    PMID: 23553712BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

September 29, 2015

First Posted

September 30, 2015

Study Start

August 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

February 2, 2016

Record last verified: 2016-02

Locations

DE(1)