Sacroiliac Joint Manipulation Effect in Chronic Piriformis Syndrome.
Primary Purpose
Piriformis Syndrome
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
HVLAT Manipulation
Conventional Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Piriformis Syndrome focused on measuring High Velocity Low Amplitude Thrust, Piriformis Syndrome, Sacroiliac joint manipulation
Eligibility Criteria
Inclusion Criteria:
- Patients having alteast 3 months chronic Piriformis syndrome
- FAIR test positive
- Unilateral or bilateral Piriformis Syndrome
Exclusion Criteria:
- 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.
Sites / Locations
- Max Rehab & Physical Therapy Centre G-8 Markaz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HVLAT Manipulation
Conventional physical therapy
Arm Description
Ultrasound, moist hot pack, piriformis stretching, myofascial release, gluteal muscles strengthening, sciatic neurodynamics, HVLAT
Ultrasound, moist hot pack, piriformis stretching, myofascial release, gluteal muscles strengthening, sciatic neurodynamics
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pressure Pain Threshold
Changes from baseline, pressure pain Threshold were taken with the help of Algometer.
Piriformis Length
Changes from the baseline, Piriformis Length were taken with the help of Goniometer.
Straight Leg Raise
Changes from baseline, Straight Leg Raise were taken with the help of Inclinometer.
Full Information
NCT ID
NCT04603703
First Posted
October 13, 2020
Last Updated
October 26, 2020
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04603703
Brief Title
Sacroiliac Joint Manipulation Effect in Chronic Piriformis Syndrome.
Official Title
Effects of Thrust Joint Manipulation of Sacroiliac Joint in Chronic Piriformis Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 9, 2020 (Actual)
Primary Completion Date
September 8, 2020 (Actual)
Study Completion Date
September 18, 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Piriformis Syndrome
Keywords
High Velocity Low Amplitude Thrust, Piriformis Syndrome, Sacroiliac joint manipulation
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
HVLAT Manipulation
Arm Type
Experimental
Arm Description
Ultrasound, moist hot pack, piriformis stretching, myofascial release, gluteal muscles strengthening, sciatic neurodynamics, HVLAT
Arm Title
Conventional physical therapy
Arm Type
Active Comparator
Arm Description
Ultrasound, moist hot pack, piriformis stretching, myofascial release, gluteal muscles strengthening, sciatic neurodynamics
Intervention Type
Other
Intervention Name(s)
HVLAT Manipulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
6th Day
Secondary Outcome Measure Information:
Title
Pressure Pain Threshold
Description
Changes from baseline, pressure pain Threshold were taken with the help of Algometer.
Time Frame
6th Day
Title
Piriformis Length
Description
Changes from the baseline, Piriformis Length were taken with the help of Goniometer.
Time Frame
6th Day
Title
Straight Leg Raise
Description
Changes from baseline, Straight Leg Raise were taken with the help of Inclinometer.
Time Frame
6th Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients having alteast 3 months chronic Piriformis syndrome
FAIR test positive
Unilateral or bilateral Piriformis Syndrome
Exclusion Criteria:
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.
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
Max Rehab & Physical Therapy Centre G-8 Markaz
City
Islamabad
State/Province
Federal
ZIP/Postal Code
46000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28932014
Citation
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.
Results Reference
background
Citation
Kutty 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.
Results Reference
background
Citation
Ellythy MA. Efficacy of muscle energy technique versus strain counter strain on low back dysfunction. Bulletin of Faculty of Physical Therapy. 2012;17(2).
Results Reference
background
PubMed Identifier
11525209
Citation
Rodrigue T, Hardy RW. Diagnosis and treatment of piriformis syndrome. Neurosurg Clin N Am. 2001 Apr;12(2):311-9.
Results Reference
background
Citation
Bose GNSC, Dusad G. EFFECT OF RECIPROCAL INHIBITION AND POST ISOMETRIC RELAXATION; TYPES OF MUSCLE ENERGY TECHNIQUE IN PIRIFORMIS SYNDROME-A COMPARATIVE STUDY.
Results Reference
background
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Sacroiliac Joint Manipulation Effect in Chronic Piriformis Syndrome.
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