The Effect Of Myofascial Release Technique On Respiratory Parameters in Subjects With Short Hamstring Muscle
Primary Purpose
Hamstring Contractures
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Myofascial Release Technique
Sham-Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Hamstring Contractures focused on measuring Hamstring Muscle, Hamstring Shortness, Hamstring Stiffness, Myofascial Release Technique, Respiratory Functions, Respiratory Muscle Strength, Respiratory Muscle Endurance
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Bezmialem Vakıf University
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Sham-Ultrasound
Myofascial Release Technique+Sham-Ultrasound
Arm Description
Intervention will include one session sham-ultrasound application to both lower extremities of participant. The total time will be 15 minutes.
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.
Outcomes
Primary Outcome Measures
Change from baseline Forced Vital Capacity (FVC) at 60 minutes
Respiratory Function Test
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 60 minutes
Respiratory Function Test
Change from baseline FEV1/FVC at 60 minutes
Respiratory Function Test
Change from baseline Peak Expiratory Flow (PEF) at 60 minutes
Respiratory Function Test
Change from baseline Forced expiratory flow over the middle one half of the FVC (FEF25-75%) at 60 minutes
Respiratory Function Test
Change from baseline maximum inspiratory pressure (MIP) at 60 minutes
Respiratory Muscle Strength Test
Change from baseline maximum expiratory pressure (MEP) at 60 minutes
Respiratory Muscle Strength Test
Change from baseline constant inspiratory threshold load test at 60 minutes
Respiratory Muscle Endurance Test
Secondary Outcome Measures
Change from baseline axillary region chest circumference measurement during inspiration at 60 minutes
Chest Circumference Measurement
Change from baseline axillary region chest circumference measurement during expiration at 60 minutes
Chest Circumference Measurement
Change from baseline xiphoid region chest circumference measurement during inspiration at 60 minutes
Chest Circumference Measurement
Change from baseline xiphoid region chest circumference measurement during expiration at 60 minutes
Chest Circumference Measurement
Change from baseline subcostal region chest circumference measurement during inspiration at 60 minutes
Chest Circumference Measurement
Change from baseline subcostal region chest circumference measurement during expiration at 60 minutes
Chest Circumference Measurement
Change from baseline axillary region chest expansion test at 60 minutes
Chest Circumference Measurement
Change from baseline xiphoid region chest expansion test at 60 minutes
Chest Circumference Measurement
Change from baseline subcostal region chest expansion test at 60 minutes
Chest Circumference Measurement
Full Information
NCT ID
NCT04193683
First Posted
December 3, 2019
Last Updated
December 26, 2021
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT04193683
Brief Title
The Effect Of Myofascial Release Technique On Respiratory Parameters in Subjects With Short Hamstring Muscle
Official Title
The Effect Of Myofascial Release Technique On Respiratory Functions, Respiratory Muscle Strength and Endurance in Subjects With Short Hamstring Muscle
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 15, 2019 (Actual)
Primary Completion Date
February 18, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Hamstring flexibility is important to maintain activities such as walking and running in daily life. Hamstring muscle shortness, commonly seen in the community, is a risk factor for many musculoskeletal pathologies. Clinical observations have shown that the shortness of the Hamstring muscle causes spinal malalignment. This deterioration of the spine alignment may adversely affect the rib cage expansion. Moreover, considering that the optimal length of the muscles provides optimal contraction, it was found that the spinal malalignment adversely affected the effective contraction of the diaphragm by changing the position of diaphragm. A different view is that, because the fascia functions as a single tissue surrounding the entire body, a restriction in the hamstring muscle can also cause a restriction in distal muscles such as diaphragm through the fascia.
There are many treatment methods used to increase the flexibility of the hamstring muscle. One of these methods is the myofascial release technique. In this technique, which targets both muscle and fascia, applying light and prolonged pressure provides the myo-fascial complex to reach its optimal length, resulting in the optimal function of the muscle. In our best knowledge, no study has evaluated the effect of myofascial release technique on respiratory parameters in patients with hamstring muscle shortness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hamstring Contractures
Keywords
Hamstring Muscle, Hamstring Shortness, Hamstring Stiffness, Myofascial Release Technique, Respiratory Functions, Respiratory Muscle Strength, Respiratory Muscle Endurance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham-Ultrasound
Arm Type
Sham Comparator
Arm Description
Intervention will include one session sham-ultrasound application to both lower extremities of participant. The total time will be 15 minutes.
Arm Title
Myofascial Release Technique+Sham-Ultrasound
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Myofascial Release Technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham-Ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Forced Vital Capacity (FVC) at 60 minutes
Description
Respiratory Function Test
Time Frame
60 minutes
Title
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 60 minutes
Description
Respiratory Function Test
Time Frame
60 minutes
Title
Change from baseline FEV1/FVC at 60 minutes
Description
Respiratory Function Test
Time Frame
60 minutes
Title
Change from baseline Peak Expiratory Flow (PEF) at 60 minutes
Description
Respiratory Function Test
Time Frame
60 minutes
Title
Change from baseline Forced expiratory flow over the middle one half of the FVC (FEF25-75%) at 60 minutes
Description
Respiratory Function Test
Time Frame
60 minutes
Title
Change from baseline maximum inspiratory pressure (MIP) at 60 minutes
Description
Respiratory Muscle Strength Test
Time Frame
60 minutes
Title
Change from baseline maximum expiratory pressure (MEP) at 60 minutes
Description
Respiratory Muscle Strength Test
Time Frame
60 minutes
Title
Change from baseline constant inspiratory threshold load test at 60 minutes
Description
Respiratory Muscle Endurance Test
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Change from baseline axillary region chest circumference measurement during inspiration at 60 minutes
Description
Chest Circumference Measurement
Time Frame
60 minutes
Title
Change from baseline axillary region chest circumference measurement during expiration at 60 minutes
Description
Chest Circumference Measurement
Time Frame
60 minutes
Title
Change from baseline xiphoid region chest circumference measurement during inspiration at 60 minutes
Description
Chest Circumference Measurement
Time Frame
60 minutes
Title
Change from baseline xiphoid region chest circumference measurement during expiration at 60 minutes
Description
Chest Circumference Measurement
Time Frame
60 minutes
Title
Change from baseline subcostal region chest circumference measurement during inspiration at 60 minutes
Description
Chest Circumference Measurement
Time Frame
60 minutes
Title
Change from baseline subcostal region chest circumference measurement during expiration at 60 minutes
Description
Chest Circumference Measurement
Time Frame
60 minutes
Title
Change from baseline axillary region chest expansion test at 60 minutes
Description
Chest Circumference Measurement
Time Frame
60 minutes
Title
Change from baseline xiphoid region chest expansion test at 60 minutes
Description
Chest Circumference Measurement
Time Frame
60 minutes
Title
Change from baseline subcostal region chest expansion test at 60 minutes
Description
Chest Circumference Measurement
Time Frame
60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betül Çınar
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Study Chair
Facility Information:
Facility Name
Bezmialem Vakıf University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect Of Myofascial Release Technique On Respiratory Parameters in Subjects With Short Hamstring Muscle
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