NCT04193683

Brief Summary

The aim of this study was to investigate the effect of myofascial release technique on rib cage mobility, respiratory function, respiratory muscle strength and endurance in patients with hamstring muscle shortness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

December 15, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

December 3, 2019

Last Update Submit

December 26, 2021

Conditions

Keywords

Hamstring MuscleHamstring ShortnessHamstring StiffnessMyofascial Release TechniqueRespiratory FunctionsRespiratory Muscle StrengthRespiratory Muscle Endurance

Outcome Measures

Primary Outcomes (8)

  • Change from baseline Forced Vital Capacity (FVC) at 60 minutes

    Respiratory Function Test

    60 minutes

  • Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 60 minutes

    Respiratory Function Test

    60 minutes

  • Change from baseline FEV1/FVC at 60 minutes

    Respiratory Function Test

    60 minutes

  • Change from baseline Peak Expiratory Flow (PEF) at 60 minutes

    Respiratory Function Test

    60 minutes

  • Change from baseline Forced expiratory flow over the middle one half of the FVC (FEF25-75%) at 60 minutes

    Respiratory Function Test

    60 minutes

  • Change from baseline maximum inspiratory pressure (MIP) at 60 minutes

    Respiratory Muscle Strength Test

    60 minutes

  • Change from baseline maximum expiratory pressure (MEP) at 60 minutes

    Respiratory Muscle Strength Test

    60 minutes

  • Change from baseline constant inspiratory threshold load test at 60 minutes

    Respiratory Muscle Endurance Test

    60 minutes

Secondary Outcomes (9)

  • Change from baseline axillary region chest circumference measurement during inspiration at 60 minutes

    60 minutes

  • Change from baseline axillary region chest circumference measurement during expiration at 60 minutes

    60 minutes

  • Change from baseline xiphoid region chest circumference measurement during inspiration at 60 minutes

    60 minutes

  • Change from baseline xiphoid region chest circumference measurement during expiration at 60 minutes

    60 minutes

  • Change from baseline subcostal region chest circumference measurement during inspiration at 60 minutes

    60 minutes

  • +4 more secondary outcomes

Study Arms (2)

Sham-Ultrasound

SHAM COMPARATOR

Intervention will include one session sham-ultrasound application to both lower extremities of participant. The total time will be 15 minutes.

Other: Sham-Ultrasound

Myofascial Release Technique+Sham-Ultrasound

EXPERIMENTAL

In addition to one session sham-ultrasound, the intervention will include one session myofascial release technique to both lower extremities of participant. The total time will be 30 minutes.

Other: Myofascial Release TechniqueOther: Sham-Ultrasound

Interventions

Myofascial release technique will bi applied bottom of the feet, back of the legs and hamstrings in both extremities. The practitioner will decide how long she should stay in a region according to the feeling of releasing in the tissue. The technique will be applied to a region at least 3 times.

Myofascial Release Technique+Sham-Ultrasound

Sham-ultrasound will be applied to back of legs and thighs in both extremities without pressure and all parameters of the ultrasound device except the timer will be closed.

Myofascial Release Technique+Sham-UltrasoundSham-Ultrasound

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • more than 15 degrees knee flexion angle during popliteal angle test,
  • no generalized joint laxity according to Beighton Criteria, and
  • no musculoskeletal problems of lower extremities.

You may not qualify if:

  • history of lower extremity and/or axial skeletal fracture;
  • recent muscle, tendon injury in lower extremity;
  • history of lumbal disc herniation, arthritic and/or inflammatory disease;
  • obesity, diabetes and/or metabolic syndrome;
  • history of surgery in the last month,
  • using muscle relaxant medication in the last month;
  • received manual therapy in the last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Myofascial Release Therapy

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Betül Çınar

    Bezmialem Vakif University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2019

First Posted

December 10, 2019

Study Start

December 15, 2019

Primary Completion

February 18, 2020

Study Completion

February 28, 2020

Last Updated

December 28, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations