Piriformis SyndromeNCT04588779
Graston vs Manual Myofascial Release Technique in Piriformis Syndrome.
A study testing Graston and Manual myofascial release in people with Piriformis Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Piriformis Syndrome
- What is being tested?
- Graston and Manual myofascial release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Jan 2020to 24 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pain more than 1 month.
- Piriformis syndrome diagnosed through screening test (FAIR test, Beatty test, Freiberg test, Sign of Pace)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Federal government polyclinic hospital
Islamabad, Fedral, 46000
About this study
Official title: Comparison of Graston and Manual Myofacial Release Technique in Patients With Piriformis Syndrome.
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.
Read the 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.
- Conditions
- Piriformis Syndrome
- Being tested
- Graston, Manual myofascial release
- Keywords
- Graston technique, Myofascial release, Lower extremity functional scale, Piriformis syndrome
- Medical subject headings
- Piriformis Muscle Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrastonOther
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.
Manual myofascial releaseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Graston | Experimental | Ultrasound, Graston technique, piriformis stretching, home plan (hip abductor and extensor strengthening) Receives: Other: Graston |
| Manual myofascial release | Active comparator | Ultrasound, Manual myofascial release, piriformis stretching, home plan (hip abductor and extensor strengthening) Receives: Other: Manual myofascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9th day
Piriformis muscle length
Changes from baseline and after 1st session, in prone lying range of internal rotation is measured for piriformis muscle length
Measured: 9th day
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.
Measured: 9th day
Secondary outcomes (1)
Straight leg raise
Changes from baseline and after 1st session, goniometer is used to measure the straight leg raise range.
Measured: 9th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start11 Jan 2020
- Primary completion17 Sep 2020
- Study completion24 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Piriformis SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Both groups were treated simultaneously with their specified treatment techniques within given duration.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asghar Khan, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588779
- Sponsor's protocol ID
- REC/00689 Sonia Wali
- Status last verified
- Oct 2020
- First submitted
- 9 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 29373060Lee 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.
PubMed 27390432Kim 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.
Awan WA, Babur MN. EFFECTIVENESS OF DEEP FRICTION MASSAGE & STRETCHING EXERCISES IN PIRIFORMIS SYNDROME. IJCRB. 2011:378.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Graston and Manual Myofacial Release Technique in Patients With Piriformis Syndrome.
- ClinicalTrials.gov ID
- NCT04588779
- Acronym / sponsor ID
- REC/00689 Sonia Wali
- Conditions
- Piriformis Syndrome
- Keywords
- Graston technique, Myofascial release, Lower extremity functional scale, Piriformis syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 11 Jan 2020 (actual)
- Primary completion
- 17 Sep 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Both groups were treated simultaneously with their specified treatment techniques within given duration.
| Arm | Type | Receives |
|---|---|---|
| Graston | Experimental | Other: GrastonUltrasound, Graston technique, piriformis stretching, home plan (hip abductor and extensor strengthening) |
| Manual myofascial release | Active comparator | Other: Manual myofascial releaseUltrasound, Manual myofascial release, piriformis stretching, home plan (hip abductor and extensor strengthening) |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pain more than 1 month.
- Piriformis syndrome diagnosed through screening test (FAIR test, Beatty test, Freiberg test, Sign of Pace)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GrastonUltrasound 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. | Other | Graston |
| Manual myofascial releaseUltrasound 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. | Other | Manual myofascial release |
Primary outcome
Numeric Pain Rating Scale
Time frame: 9th day
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
Time frame: 9th day
Changes from baseline and after 1st session, in prone lying range of internal rotation is measured for piriformis muscle length
Lower extremity functional scale
Time frame: 9th day
Changes from baseline and after 1st session, lower extremity functional scale is used to measure the functional status of patients with piriformis syndrome.
1 secondary outcome
Straight leg raise
Time frame: 9th day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- BackgroundKukadia 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.
- Background: PubMed 29373060Stanek 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.
- Background: PubMed 27390432Lee 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.
- BackgroundKim 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.
- BackgroundAwan WA, Babur MN. EFFECTIVENESS OF DEEP FRICTION MASSAGE & STRETCHING EXERCISES IN PIRIFORMIS SYNDROME. IJCRB. 2011:378.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asghar Khan, Phd principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graston and Manual myofascial release in people with Piriformis Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 9th day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04588779, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.