- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05660005
Self Myofascial Release in Individuals With Piriformis Syndrome
The Effect of Self Myofascial Release and Stretching Exercises in Individuals With Piriformis Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Piriformis syndrome (PS) is a condition caused by compression of the sciatic nerve, causing pain, tingling, and numbness. Although conservative treatment includes hip muscle strengthening and stretching, there is no proven treatment method in the literature.
This study will be conducted to investigate the effect of stretching and myofascial release added to standard physiotherapy treatment in piriformis syndrome.
This prospective, randomized controlled study will be planned to completed with 64 individuals between the ages of 20-40. Participants will be randomized into the Piriformis Muscle Stretch Group (PiM-S) and Piriformis Muscle Self Myofascial Release Group (PiM-SMR). Both groups will be included in a home program of muscle strengthening exercises for 4 weeks. And groups will be subjected to perform stretching and self-myofascial relaxation exercises, respectively, in addition to the home exercise program. The primary outcome of the study is pain intensity, and the secondary outcome is determined as the range of motion (ROM) of the hip.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beykoz
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Istanbul, Beykoz, Turkey, 34810
- Gizem Ergezen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female participants
- Aged 20 to 40 years
- Presented leg or hip posterior compartment pain
- Diagnosed with chronic PS and without any other source of pain
Exclusion Criteria:
- Any pathology or acute injury around the hip, sacroiliac joint, or lumbar spine;
- Limb length discrepancy,
- Recent buttock trauma,
- Deep gluteal syndrome,
- Extrapelvic compression of the sciatic nerve or sacral plexus ischiogluteal/ischiofemoral bursitis or impingement, Upper hamstring tendinitis,
- Fibromyalgia, myofascial pain syndrome
- Pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Piriformis Muscle Stretching
Stretching based on the FAIR (flexion, adduction and internal rotation) position, which provides the most effective stretching on the piriformis muscle, was demonstrated, and a illustrated brochure containing the explanatory information of the application was given to the group participants.
With the ipsilateral hip flexion, adduction and internal rotation, the foot is positioned to the lateral side of the contralateral knee, thus long-term passive stretching is targeted in this position.
Individuals were asked to leave a 2-days gap between the two stretching exercise sessions by performing 10 repetitions (minimum duration of 15 s stretching, 30 s rest period between repetitions) 3 sets and 3 days of a week.
|
Stretching based on the FAIR (flexion, adduction and internal rotation) position, which provides the most effective stretching on the piriformis muscle, was demonstrated, and a illustrated brochure containing the explanatory information of the application was given to the group participants.
With the ipsilateral hip flexion, adduction and internal rotation, the foot is positioned to the lateral side of the contralateral knee, thus long-term passive stretching is targeted in this position.
Individuals were asked to leave a 2-days gap between the two stretching exercise sessions by performing 10 repetitions (minimum duration of 15 s stretching, 30 s rest period between repetitions) 3 sets and 3 days of a week.
Other Names:
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|
Active Comparator: Piriformis Muscle Self Myofascial Release
The patient was presented with the anatomically localized area of the PiM on a visual anatomy map and they were encouraged to find this area on their body.
They were asked to verify the trigger points along the PiM and then sat on the trigger points with the help of a tennis ball.
Individuals were taught the PiM-SMR exercise, in which they would make forward-backward, right-left, diagonal and circular movements on the ball using their body weight.
There was a continuation of the application with an interval of 2 days; 3 times a day with 10 repetitions (the application was for 1 min and 30s rest period between repetitions).
|
The patient was presented with the anatomically localized area of the PiM on a visual anatomy map and they were encouraged to find this area on their body.
They were asked to verify the trigger points along the PiM and then sat on the trigger points with the help of a tennis ball.
Individuals were taught the PiM-SMR exercise, in which they would make forward-backward, right-left, diagonal and circular movements on the ball using their body weight.
There was a continuation of the application with an interval of 2 days; 3 times a day with 10 repetitions (the application was for 1 min and 30s rest period between repetitions).
|
|
Experimental: Control Group
The individuals who refused to apply stretching or releasing included to the control group.
They perform only home exercises of hip strengthening
|
The exercise brochure consists of 5 different exercises that include isometric and isotonic strengthening of the hip and surrounding muscles.
Isometric contraction of gluteus maximus, hip march, external/internal rotation of hips with theraband, 4 sided straight leg raises were the exercises and prescribed 5 days a week, 10 repetitions, 3 sets.
All participants were advised to use analgesics determined by the physician in case of unbearable pain and to apply a hot pack for 10-20 minutes before sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: 4 weeks
|
The severity of sciatic pain extending along the hip and leg was questioned with the Visual Analog Scale (VAS).
The assessment was based on a horizontal 10 cm scale from 1 (least pain) to 10 (the worst pain ever)
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Extension Range of motion of the hip angle
Time Frame: 4 weeks
|
Extension ROM was measured while the individual was in the pronee position, the pivot point of the goniometer at the trochanter major, the moving arm aligned on the lateral midline of the femur, and the stable arm aligned parallel to the ground.
|
4 weeks
|
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Flexion Range of motion of the hip angle
Time Frame: 4 weeks
|
Flexion ROM was measured while the individual was in the supine position, the pivot point of the goniometer at the trochanter major, the moving arm aligned on the lateral midline of the femur, and the stable arm aligned parallel to the ground.
|
4 weeks
|
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Adduction Range of motion of the hip angle
Time Frame: 4 weeks
|
Adduction ROM were evaluated in the supine position, with the pivot point on the anterior projection of the trochanter major, the stable arm parallel to the anterior superior of the spina iliaca, and the moving arm on the anterior midline of the femur.
Femur approached to the midline
|
4 weeks
|
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Abduction Range of motion of the hip angle
Time Frame: 4 weeks
|
Abduction and adduction ROM were evaluated in the supine position, with the pivot point on the anterior projection of the trochanter major, the stable arm parallel to the anterior superior of the spina iliaca, and the moving arm on the anterior midline of the femur.
During the evaluation of abduction, attention was paid to the absence of external rotation of the hip and the absence of internal rotation of the hip in adduction.
|
4 weeks
|
|
External Rotation Range of motion of the hip angle
Time Frame: 4 weeks
|
The measurement was taken in a prone position, with the knees flexed to 90°, pivot point on the tibial tubercle, with the stable arm perpendicular to the ground and the mobile arm following the tibial crista.
During the evaluation, attention was paid to the absence of hip adduction and abduction movement.
Knee turned externally
|
4 weeks
|
|
Internal Rotation Range of motion of the hip angle
Time Frame: 4 weeks
|
The measurement was taken in a prone position, with the knees flexed to 90°, pivot point on the tibial tubercle, with the stable arm perpendicular to the ground and the mobile arm following the tibial crista.
During the evaluation, attention was paid to the absence of hip adduction and abduction movement.
Knee turned internally
|
4 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gizem Ergezen, PhD, Medipol University
- Study Director: Mustafa Sahin, PhD, Medipol University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E.10304 / 29.03.2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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