Graston vs Manual Myofascial Release Technique in Piriformis Syndrome.
Primary Purpose
Piriformis Syndrome
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Graston
Manual myofascial release
Sponsored by
About this trial
This is an interventional treatment trial for Piriformis Syndrome focused on measuring Graston technique, Myofascial release, Lower extremity functional scale, Piriformis syndrome
Eligibility Criteria
Inclusion Criteria:•
- Pain more than 1 month.
- Piriformis syndrome diagnosed through screening test (FAIR test, Beatty test, Freiberg test, Sign of Pace)
Exclusion Criteria:
- Leg pain due to causes other than piriformis syndrome.
- Congenital spinal deformity.
- History of fracture.
- History of back or hip surgery.
- Any systemic illness like metastatic or infective disorders.
Sites / Locations
- Federal government polyclinic hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Graston
Manual myofascial release
Arm Description
Ultrasound, Graston technique, piriformis stretching, home plan (hip abductor and extensor strengthening)
Ultrasound, Manual myofascial release, piriformis stretching, home plan (hip abductor and extensor strengthening)
Outcomes
Primary Outcome Measures
Numeric Pain Rating Scale
Changes from baseline and after 1st session, Numeric pain rating scale is a scale from 0 to 10. 0 indicating no pain and 10 indicating worse pain.
Piriformis muscle length
Changes from baseline and after 1st session, in prone lying range of internal rotation is measured for piriformis muscle length
Lower extremity functional scale
Changes from baseline and after 1st session, lower extremity functional scale is used to measure the functional status of patients with piriformis syndrome.
Secondary Outcome Measures
Straight leg raise
Changes from baseline and after 1st session, goniometer is used to measure the straight leg raise range.
Full Information
NCT ID
NCT04588779
First Posted
October 9, 2020
Last Updated
October 9, 2020
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04588779
Brief Title
Graston vs Manual Myofascial Release Technique in Piriformis Syndrome.
Official Title
Comparison of Graston and Manual Myofacial Release Technique in Patients With Piriformis Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 11, 2020 (Actual)
Primary Completion Date
September 17, 2020 (Actual)
Study Completion Date
September 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International 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 objective of our study is to compare the effects of Graston and manual myofascial release technique on pain, muscle length and functional status in patients with Piriformis syndrome.
Detailed Description
In 2019, a study was conducted to conclude the effectiveness of Passive stretching v/s Myofascial release in improving Piriformis flexibility in females. They reported that myofascial release was more valuable than passive stretching exercises in enhancing piriformis flexibility in patients with piriformis tightness.
According to another study in 2018, after a single treatment, compressive myofascial release showed more improvement in ankle dorsiflexion than Graston technique, in participants with decrease dorsiflexion range.
In 2016, a study reported the effects of the Graston technique and general exercise in patients with chronic low back pain. Graston group showed greater improvement in pain and range of motion in patients with chronic low back pain.
According to a study conducted in 2014, self-myofascial release was more effective than Graston technique in improving knee joint flexibility, hamstring, and quadriceps strength.
In 2011, a study evaluated the effectiveness of deep soft tissue mobilization techniques and stretching exercises in piriformis syndrome and found that the deep soft tissue mobilization techniques along with stretching exercises significantly improved the piriformis syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Piriformis Syndrome
Keywords
Graston technique, Myofascial release, Lower extremity functional scale, Piriformis syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Both groups were treated simultaneously with their specified treatment techniques within given duration.
Masking
Participant
Masking Description
Participants did not know which treatment techniques are given in the specified groups.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Graston
Arm Type
Experimental
Arm Description
Ultrasound, Graston technique, piriformis stretching, home plan (hip abductor and extensor strengthening)
Arm Title
Manual myofascial release
Arm Type
Active Comparator
Arm Description
Ultrasound, Manual myofascial release, piriformis stretching, home plan (hip abductor and extensor strengthening)
Intervention Type
Other
Intervention Name(s)
Graston
Intervention Description
Ultrasound for 10 mins/1 set/ (3 sessions/week), Graston for 5 mins/1 set/ (3 sessions/week), Piriformis stretching exercises/ 10 reps with 30 sec hold/ 1 set/(3 sessions/week), Hip abductor strengthening/10 reps/1 set/(3 weeks), Hip extensor strengthening/10 reps/1 set/(3 weeks),
A total of 9 sessions for 3 weeks (3 sessions/week) were given each consisting of 20 mins.
Intervention Type
Other
Intervention Name(s)
Manual myofascial release
Intervention Description
Ultrasound for 10 mins/1 set/ (3 sessions/week), Manual myofascial release for 5 mins/1 set/ (3 sessions/week), Piriformis stretching exercises/ 10 reps with 30 sec hold/ 1 set/(3 sessions/week), Hip abductor strengthening/10 reps/1 set/(3 weeks), Hip extensor strengthening/10 reps/1 set/(3 weeks),
A total of 9 sessions for 3 weeks (3 sessions/week) were given each consisting of 20 mins.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
Changes from baseline and after 1st session, Numeric pain rating scale is a scale from 0 to 10. 0 indicating no pain and 10 indicating worse pain.
Time Frame
9th day
Title
Piriformis muscle length
Description
Changes from baseline and after 1st session, in prone lying range of internal rotation is measured for piriformis muscle length
Time Frame
9th day
Title
Lower extremity functional scale
Description
Changes from baseline and after 1st session, lower extremity functional scale is used to measure the functional status of patients with piriformis syndrome.
Time Frame
9th day
Secondary Outcome Measure Information:
Title
Straight leg raise
Description
Changes from baseline and after 1st session, goniometer is used to measure the straight leg raise range.
Time Frame
9th day
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
According to the feasibility of patients and examiner for assessment, only female patients were included in the study.
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:•
Pain more than 1 month.
Piriformis syndrome diagnosed through screening test (FAIR test, Beatty test, Freiberg test, Sign of Pace)
Exclusion Criteria:
Leg pain due to causes other than piriformis syndrome.
Congenital spinal deformity.
History of fracture.
History of back or hip surgery.
Any systemic illness like metastatic or infective disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asghar Khan, Phd
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal government polyclinic hospital
City
Islamabad
State/Province
Fedral
ZIP/Postal Code
46000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Kukadia HA, Malshikare A, Palekar TJ. Effect of Passive Stretching v/s Myofascial Release in Improving Piriformis Flexibility in Females-A Comparative Study. Indian Journal of Physiotherapy and Occupational Therapy-An International Journal. 2019;13(4):57-61.
Results Reference
background
PubMed Identifier
29373060
Citation
Stanek J, Sullivan T, Davis S. Comparison of Compressive Myofascial Release and the Graston Technique for Improving Ankle-Dorsiflexion Range of Motion. J Athl Train. 2018 Feb;53(2):160-167. doi: 10.4085/1062-6050-386-16. Epub 2018 Jan 26.
Results Reference
background
PubMed Identifier
27390432
Citation
Lee JH, Lee DK, Oh JS. The effect of Graston technique on the pain and range of motion in patients with chronic low back pain. J Phys Ther Sci. 2016 Jun;28(6):1852-5. doi: 10.1589/jpts.28.1852. Epub 2016 Jun 28.
Results Reference
background
Citation
Kim D-H, Ms T-HK, Jung D-Y, Weon J-H. Effects of the graston technique and self-myofascial release on the range of motion of a knee joint. Journal of Korean Society of Physical Medicine. 2014;9(4):455-63.
Results Reference
background
Citation
Awan WA, Babur MN. EFFECTIVENESS OF DEEP FRICTION MASSAGE & STRETCHING EXERCISES IN PIRIFORMIS SYNDROME. IJCRB. 2011:378.
Results Reference
background
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Graston vs Manual Myofascial Release Technique in Piriformis Syndrome.
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