Piriformis SyndromeNCT04603703
Sacroiliac Joint Manipulation Effect in Chronic Piriformis Syndrome.
A study testing HVLAT Manipulation and Conventional Physical Therapy in people with Piriformis Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
The objective of the study was to determine the effects of sacroiliac joint thrust manipulation on pain, pain pressure threshold, piriformis length and straight leg raise, in chronic piriformis syndrome. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Piriformis Syndrome
- What is being tested?
- HVLAT Manipulation and Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 9 May 2020to 18 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients having alteast 3 months chronic Piriformis syndrome
- FAIR test positive
- Unilateral or bilateral Piriformis Syndrome
Who cannot join
- Lumber Prolapsed Intervertebral Disc (PIVD)
- Patients having hip osteoarthritis
- Sacroiliatis (FABER test, Mennell's test, Sacral Thrust Test, Compression test, Distraction test, thigh thrust test)
- Lumbosacral instability
- Patients having any joint replacement in lumbosacral and hip regions.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Max Rehab & Physical Therapy Centre G-8 Markaz
Islamabad, Federal, 46000
About this study
Official title: Effects of Thrust Joint Manipulation of Sacroiliac Joint in Chronic Piriformis Syndrome
The objective of the study was to determine the effects of sacroiliac joint thrust manipulation on pain, pain pressure threshold, piriformis length and straight leg raise, in chronic piriformis syndrome.
Read the detailed description
In 2017, a systematic review was conducted to measure the effectiveness of physical therapy approach for relieving the SIJ pain linked with PS. Participants were administered with conservative physical therapy, Kinesiology taping and sacroiliac joint manipulation in group A, group B and group C respectively. They have concluded that Sacroiliac joint manipulation was more effective as compare to the rest of the physiotherapy approach in lowering the SIJ pain associated with piriformis syndrome.
In 2014, an experimental study was conducted to compare the effects of nerve mobilization technique with conventional physical therapy approach. Pre and post treatment data was taken from the respective participants. The results of this study concluded that there is a significant differences in the outcome measures of both groups and nerve MOBS were proven to be more effective in relieving the sciatic nerve radiating pain associated with inflamed piriformis muscle in PS.
A study in July, 2012 was conducted to compare the effects of two possible physical therapy treatments in lowering the low back pain threshold associated with piriformis syndrome. These two techniques were METs and SCS. Their results concluded that both Muscle energy technique and Strain counter strain were proved to be equally effective in the management of functional disability and pain in low back associated with chronic PS.
An RCT was conducted in 2011, to measure the effectiveness of two possible manipulation methods which can be applied in patients with chronic piriformis syndrome. According to this study, manipulating the of SIJ along with lumber manipulation is more effective as compare to the SIJ manipulation alone to regain the total piriformis length for patients with Chronic PS.
Another study was conducted by Gopal Nambi and colleagues in Saudi Arabia. It was concluded that Program comprises of Post Isometric Relaxation is more effective as compare to conservative physical therapy in alleviating the pain, improving hip ROM and functional improvement in participants with PS.
- Conditions
- Piriformis Syndrome
- Being tested
- HVLAT Manipulation, Conventional Physical Therapy
- Keywords
- High Velocity Low Amplitude Thrust, Piriformis Syndrome, Sacroiliac joint manipulation
- 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.
HVLAT ManipulationOther
Ultrasound for 10 mins/1 set/ (3 days/ week), Moist hot pack for 10 mins/1 set/ (3 days/ week), Piriformis stretching for 7 sec hold/ 7 repititions/ 1 set/ (3 days/ week), Myofascial release of lumbosacral paraspinal muscles for 3 mins/ 1 set/ (3 days/ week), Gluteal muscles strengthening for 10 sec hold/ 5 reps/ 1 set/ (3 days/ week), Sciatic Neurodynamics with 10 oscillations/ 3 sets/(3 days/ week), HVLAT manipulation/ 1 rep/ 1set/ (3 days/ week),
A total of 2 weeks (6 sessions, 3 sessions/ week) were given each consisting of 30 mins.
Conventional Physical TherapyOther
Ultrasound for 10 mins/1 set/ (3 days/ week), Moist hot pack for 10 mins/1 set/ (3 days/ week), Piriformis stretching for 7 sec hold/ 7 repititions/ 1 set/ (3 days/ week), Myofascial release of lumbosacral paraspinal muscles for 3 mins/ 1 set/ (3 days/ week), Gluteal muscles strengthening for 10 sec hold/ 5 reps/ 1 set/ (3 days/ week), Sciatic Neurodynamics with 10 oscillations/ 3 sets/(3 days/ week),
A total of 2 weeks (6 sessions, 3 sessions/ week) were given each consisting of 30 mins.
| Study group | Role | What they receive |
|---|---|---|
| HVLAT Manipulation | Experimental | Ultrasound, moist hot pack, piriformis stretching, myofascial release, gluteal muscles strengthening, sciatic neurodynamics, HVLAT Receives: Other: HVLAT Manipulation |
| Conventional physical therapy | Active comparator | Ultrasound, moist hot pack, piriformis stretching, myofascial release, gluteal muscles strengthening, sciatic neurodynamics Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
Changes from baseline, Numeric Pain Rating Scale is a scale for pain starting from 0 to 10 where 0 indicates no pain and 10 indicates severe pain.
Measured: 6th Day
Secondary outcomes (3)
Pressure Pain Threshold
Changes from baseline, pressure pain Threshold were taken with the help of Algometer.
Measured: 6th Day
Piriformis Length
Changes from the baseline, Piriformis Length were taken with the help of Goniometer.
Measured: 6th Day
Straight Leg Raise
Changes from baseline, Straight Leg Raise were taken with the help of Inclinometer.
Measured: 6th Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start9 May 2020
- Primary completion8 Sep 2020
- Study completion18 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
- NCT04603703
- Sponsor's protocol ID
- REC/00693 Benish Shahzadi
- Status last verified
- Oct 2020
- First submitted
- 13 Oct 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Subahi M, Alayat M, Alshehri MA, Helal O, Alhasan H, Alalawi A, Takrouni A, Alfaqeh A. The effectiveness of physiotherapy interventions for sacroiliac joint dysfunction: a systematic review. J Phys Ther Sci. 2017 Sep;29(9):1689-1694. doi: 10.1589/jpts.29.1689. Epub 2017 Sep 15.
PubMed 28932014Kutty RK, Gebrekidan HG, Lerebo WT, Gebretsadik MA. Neural mobilization a therapeutic efficacy in a piriformis syndrome model: an experimental study. International journal of physiotherapy and research. 2014;2(3):577-83.
Ellythy MA. Efficacy of muscle energy technique versus strain counter strain on low back dysfunction. Bulletin of Faculty of Physical Therapy. 2012;17(2).
Rodrigue T, Hardy RW. Diagnosis and treatment of piriformis syndrome. Neurosurg Clin N Am. 2001 Apr;12(2):311-9.
PubMed 11525209Bose GNSC, Dusad G. EFFECT OF RECIPROCAL INHIBITION AND POST ISOMETRIC RELAXATION; TYPES OF MUSCLE ENERGY TECHNIQUE IN PIRIFORMIS SYNDROME-A COMPARATIVE STUDY.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thrust Joint Manipulation of Sacroiliac Joint in Chronic Piriformis Syndrome
- ClinicalTrials.gov ID
- NCT04603703
- Acronym / sponsor ID
- REC/00693 Benish Shahzadi
- Conditions
- Piriformis Syndrome
- Keywords
- High Velocity Low Amplitude Thrust, Piriformis Syndrome, Sacroiliac joint manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 9 May 2020 (actual)
- Primary completion
- 8 Sep 2020 (actual)
- Study completion
- 18 Sep 2020 (actual)
- First posted
- 27 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 the study was to determine the effects of sacroiliac joint thrust manipulation on pain, pain pressure threshold, piriformis length and straight leg raise, in chronic piriformis syndrome.
Detailed description
In 2017, a systematic review was conducted to measure the effectiveness of physical therapy approach for relieving the SIJ pain linked with PS. Participants were administered with conservative physical therapy, Kinesiology taping and sacroiliac joint manipulation in group A, group B and group C respectively. They have concluded that Sacroiliac joint manipulation was more effective as compare to the rest of the physiotherapy approach in lowering the SIJ pain associated with piriformis syndrome.
In 2014, an experimental study was conducted to compare the effects of nerve mobilization technique with conventional physical therapy approach. Pre and post treatment data was taken from the respective participants. The results of this study concluded that there is a significant differences in the outcome measures of both groups and nerve MOBS were proven to be more effective in relieving the sciatic nerve radiating pain associated with inflamed piriformis muscle in PS.
A study in July, 2012 was conducted to compare the effects of two possible physical therapy treatments in lowering the low back pain threshold associated with piriformis syndrome. These two techniques were METs and SCS. Their results concluded that both Muscle energy technique and Strain counter strain were proved to be equally effective in the management of functional disability and pain in low back associated with chronic PS.
An RCT was conducted in 2011, to measure the effectiveness of two possible manipulation methods which can be applied in patients with chronic piriformis syndrome. According to this study, manipulating the of SIJ along with lumber manipulation is more effective as compare to the SIJ manipulation alone to regain the total piriformis length for patients with Chronic PS.
Another study was conducted by Gopal Nambi and colleagues in Saudi Arabia. It was concluded that Program comprises of Post Isometric Relaxation is more effective as compare to conservative physical therapy in alleviating the pain, improving hip ROM and functional improvement in participants with PS.
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 |
|---|---|---|
| HVLAT Manipulation | Experimental | Other: HVLAT ManipulationUltrasound, moist hot pack, piriformis stretching, myofascial release, gluteal muscles strengthening, sciatic neurodynamics, HVLAT |
| Conventional physical therapy | Active comparator | Other: Conventional Physical TherapyUltrasound, moist hot pack, piriformis stretching, myofascial release, gluteal muscles strengthening, sciatic neurodynamics |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients having alteast 3 months chronic Piriformis syndrome
- FAIR test positive
- Unilateral or bilateral Piriformis Syndrome
Key exclusion criteria (5 listed)
- Lumber Prolapsed Intervertebral Disc (PIVD)
- Patients having hip osteoarthritis
- Sacroiliatis (FABER test, Mennell's test, Sacral Thrust Test, Compression test, Distraction test, thigh thrust test)
- Lumbosacral instability
- Patients having any joint replacement in lumbosacral and hip regions.
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 |
|---|---|---|
| HVLAT ManipulationUltrasound for 10 mins/1 set/ (3 days/ week), Moist hot pack for 10 mins/1 set/ (3 days/ week), Piriformis stretching for 7 sec hold/ 7 repititions/ 1 set/ (3 days/ week), Myofascial release of lumbosacral paraspinal muscles for 3 mins/ 1 set/ (3 days/ week), Gluteal muscles strengthening for 10 sec hold/ 5 reps/ 1 set/ (3 days/ week), Sciatic Neurodynamics with 10 oscillations/ 3 sets/(3 days/ week), HVLAT manipulation/ 1 rep/ 1set/ (3 days/ week), A total of 2 weeks (6 sessions, 3 sessions/ week) were given each consisting of 30 mins. | Other | HVLAT Manipulation |
| Conventional Physical TherapyUltrasound for 10 mins/1 set/ (3 days/ week), Moist hot pack for 10 mins/1 set/ (3 days/ week), Piriformis stretching for 7 sec hold/ 7 repititions/ 1 set/ (3 days/ week), Myofascial release of lumbosacral paraspinal muscles for 3 mins/ 1 set/ (3 days/ week), Gluteal muscles strengthening for 10 sec hold/ 5 reps/ 1 set/ (3 days/ week), Sciatic Neurodynamics with 10 oscillations/ 3 sets/(3 days/ week), A total of 2 weeks (6 sessions, 3 sessions/ week) were given each consisting of 30 mins. | Other | Conventional physical therapy |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 6th Day
Changes from baseline, Numeric Pain Rating Scale is a scale for pain starting from 0 to 10 where 0 indicates no pain and 10 indicates severe pain.
3 secondary outcomes
Pressure Pain Threshold
Time frame: 6th Day
Piriformis Length
Time frame: 6th Day
Straight Leg Raise
Time frame: 6th 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 27 Oct 2020.
- Background: PubMed 28932014Al-Subahi M, Alayat M, Alshehri MA, Helal O, Alhasan H, Alalawi A, Takrouni A, Alfaqeh A. The effectiveness of physiotherapy interventions for sacroiliac joint dysfunction: a systematic review. J Phys Ther Sci. 2017 Sep;29(9):1689-1694. doi: 10.1589/jpts.29.1689. Epub 2017 Sep 15.
- BackgroundKutty RK, Gebrekidan HG, Lerebo WT, Gebretsadik MA. Neural mobilization a therapeutic efficacy in a piriformis syndrome model: an experimental study. International journal of physiotherapy and research. 2014;2(3):577-83.
- BackgroundEllythy MA. Efficacy of muscle energy technique versus strain counter strain on low back dysfunction. Bulletin of Faculty of Physical Therapy. 2012;17(2).
- Background: PubMed 11525209Rodrigue T, Hardy RW. Diagnosis and treatment of piriformis syndrome. Neurosurg Clin N Am. 2001 Apr;12(2):311-9.
- BackgroundBose GNSC, Dusad G. EFFECT OF RECIPROCAL INHIBITION AND POST ISOMETRIC RELAXATION; TYPES OF MUSCLE ENERGY TECHNIQUE IN PIRIFORMIS SYNDROME-A COMPARATIVE STUDY.
- 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 HVLAT Manipulation and Conventional Physical Therapy 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 3 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 27 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 (NPRS) (time frame: 6th Day). 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 NCT04603703, 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 27 Oct 2020.