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Self Myofascial Release in Individuals With Piriformis Syndrome

Primary Purpose

Piriformis Muscle Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Muscle Stretching
Self Myofascial Release
home exercises
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Piriformis Muscle Syndrome focused on measuring Piriformis syndrome, Pain, hip, range of motion, sciatica

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gizem Ergezen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Piriformis Muscle Stretching

Piriformis Muscle Self Myofascial Release

Control Group

Arm Description

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.

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 individuals who refused to apply stretching or releasing included to the control group. They perform only home exercises of hip strengthening

Outcomes

Primary Outcome Measures

Pain Intensity
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)

Secondary Outcome Measures

Extension Range of motion of the hip angle
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.
Flexion Range of motion of the hip angle
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.
Adduction Range of motion of the hip angle
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
Abduction Range of motion of the hip angle
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.
External Rotation Range of motion of the hip angle
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
Internal Rotation Range of motion of the hip angle
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

Full Information

First Posted
December 5, 2022
Last Updated
December 13, 2022
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05660005
Brief Title
Self Myofascial Release in Individuals With Piriformis Syndrome
Official Title
The Effect of Self Myofascial Release and Stretching Exercises in Individuals With Piriformis Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 8, 2019 (Actual)
Primary Completion Date
May 7, 2022 (Actual)
Study Completion Date
December 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Piriformis syndrome is pain that extends from the hip to the knee, caused by the pressure of the piriformis muscle in the hip on the sciatic nerve. There is no valid protocol for the treatment of this syndrome. Physiotherapists generally use hip strengthening exercises and modalities for pain. In this study, in addition to the classical treatment, we will give two different programs consisting of self-myofascial relaxation and stretching exercises to two different groups for 4 weeks as home exercise. We will question the level of pain that people felt in the hip before starting the exercises and at the 4th week after starting the exercises and measured the hip joint range of motion.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Piriformis Muscle Syndrome
Keywords
Piriformis syndrome, Pain, hip, range of motion, sciatica

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel group study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Piriformis Muscle Stretching
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Piriformis Muscle Self Myofascial Release
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Control Group
Arm Type
Experimental
Arm Description
The individuals who refused to apply stretching or releasing included to the control group. They perform only home exercises of hip strengthening
Intervention Type
Other
Intervention Name(s)
Muscle Stretching
Other Intervention Name(s)
Piriformis Muscle Stretching
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Self Myofascial Release
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
home exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
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)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Extension Range of motion of the hip angle
Description
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.
Time Frame
4 weeks
Title
Flexion Range of motion of the hip angle
Description
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.
Time Frame
4 weeks
Title
Adduction Range of motion of the hip angle
Description
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
Time Frame
4 weeks
Title
Abduction Range of motion of the hip angle
Description
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.
Time Frame
4 weeks
Title
External Rotation Range of motion of the hip angle
Description
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
Time Frame
4 weeks
Title
Internal Rotation Range of motion of the hip angle
Description
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
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gizem Ergezen, PhD
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mustafa Sahin, PhD
Organizational Affiliation
Medipol University
Official's Role
Study Director
Facility Information:
Facility Name
Gizem Ergezen
City
Istanbul
State/Province
Beykoz
ZIP/Postal Code
34810
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Self Myofascial Release in Individuals With Piriformis Syndrome

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