Piriformis SyndromeNCT06406023
Effectiveness of Instrument Assisted Soft Tissue Mobilization in Management of Piriformis Syndrome
A study testing Conventional treatment and Instrument assisted soft tissue mobilization in people with Piriformis Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study aims to assess the effectiveness of IASTM on pain, ROM, Disability and Quality of life among Piriformis Syndrome patients. This study will add to the growing body of knowledge as there are very limited researches done in Pakistan using IASTM in patients with Piriformis Syndrome. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Piriformis Syndrome
- What is being tested?
- Conventional treatment and Instrument assisted soft tissue mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2024to 30 Jun 2024
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed patients of Piriformis syndrome.
- Only females will be included in this study.
- Participants aged 30-65 years.
- Pain due to non-discogenic sciatic nerve entrapment in sub gluteal space.
- Pain aggravated by prolonged sitting, lying, standing.
- Positive FAIR test, Pace sign, Laseque sign, Beatty maneuver and Freiberg test.
- Negative Kemp sign, Milgram's test, Bowstring test, Braggard test and Lasegue differential test.
Who cannot join
- Patients with any Intrinsic Etiology such as Haemarthrosis, rheumatoid arthritis or infection.
- Patients with any recent severe trauma, fractures, subluxation or ligament injury.
- Malignancy, Open wound Fracture, DVT, Compartment syndrome, Pregnancy.
- Patients with irreversible nerve damage.
- Patients with lumbar disc herniation or any disc pathology.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Railway General Hospital
Rawalpindi, Punjab Province
Ramsha Tariq, Masters, 0331-5251422, ramsha.tariq@riphah.edu.pk
Neha Noor, Masters
About this study
This study aims to assess the effectiveness of IASTM on pain, ROM, Disability and Quality of life among Piriformis Syndrome patients. This study will add to the growing body of knowledge as there are very limited researches done in Pakistan using IASTM in patients with Piriformis Syndrome.
Read the detailed description
Instrument assisted soft tissue mobilization (IASTM) is a skilled intervention that includes the use of specialized tools to manipulate the skin, myofascia, muscles, and tendons by various direct compressive stroke techniques. It has neurophysiological effect as it stimulates mechanosensitive neurons through skin deformation by using instrument. IASTM affects the vascular response to the injured soft tissue, through increasing the blood flow, reduce the stress and strain to the injured areas, decrease inflammation, increase muscle flexibility and strength, increase blood flow, break up scar tissue, promote proper tissue repair, enhance functional movements, accelerates fibroblast activity.
In 2022 there is a study that stated the overall Prevalence of piriformis muscle syndrome which is 18.3%. The Mean±SD of exact BMI were 27.43±6.859. Male and female Pace sign were 14.2% and 18.3% positive respectively.
Positive Prevalence of piriformis muscle syndrome in the general population in Age groups chi-square value is (47.753b) and P- Value (<0.001).
A 2018 study determined that Hip abductor and extensor strengthening along with neural mobilization and piriformis stretching have significant effect on improving hip abductor strength and lower extremity function when compared with neural mobilization and piriformis stretching alone in patients with Piriformis syndrome.
Another study conducted in 2022, showed the effects of IASTM in discogenic Sciatica along with neural mobilization and lumbar traction and concluded that IASTM alleviated pain and impairments in patients with sciatic nerve entrapment. Whereas, this study will assess the effectiveness of IASTM in non discogenic causes of piriformis syndrome.
A 2016 study showed the efficacy of manual therapy interventions for improving the signs and symptoms of carpal tunnel syndrome by comparing 2 manual therapy techniques: Graston Instrument-assisted soft tissue mobilization (GISTM) and soft tissue mobilization for mild to moderate cases of CTS. Results shows improvements in both groups with pain, nerve conduction latencies, wrist strength and ROM. This study will only assess the effectiveness of IASTM on pain, ROM, disability and quality of life among patients with piriformis syndrome.
Reference article showed efficacy by comparing 2 manual therapy techniques, GISTM and STM in management of carpal tunnel syndrome. There is significant improvement in wrist strength and ROM with IASTM application as it increases muscle flexibility and strength, improves blood flow, breaks up adhesions, reduce stress to injured area, enhance functional movements, increase fibroblastic activity and decreases inflammation. Current study will only assess effectiveness of IASTM on pain, ROM, functional disability and QOL among patients with piriformis syndrome. No evidence in previous studies shows efficacy of IASTM with Graston tool in management of piriformis syndrome. Hence, this study will show effectiveness of IASTM on pain, ROM, disability and quality of life in patients with piriformis syndrome.
- Conditions
- Piriformis Syndrome
- Being tested
- Conventional treatment, Instrument assisted soft tissue mobilization
- 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.
Conventional treatmentOther
Hot pack will be applied for 10 minutes. AROM's of Hip (5 reps x 2 sets each). Piriformis stretch 3 reps x 20 sec hold x 2 sets. SLR (5reps x 10 sec hold x 2 sets). Sciatic nerve stretch (5 reps x 10 sec hold x 2 sets) for 3 days/ week for 2 weeks.
Strengthening exercises will be performed after 2 weeks of previous intervention of Hip abductors (Hip abduction with band in sitting, standing, side-lying hip raise), and hip extensors (Gluteal bridges, Prone hip extension, Prone hams curl). (5 reps x 2 sets each).
SLR (5 reps x 10 sec hold x 2 sets) each exercise will be performed 3 days/ week for 2 weeks.
Total treatment protocol will be followed for 4 weeks. Each session will be of 30 minutes.
Instrument assisted soft tissue mobilizationOther
Instrument assisted soft tissue mobilization IASTM with Graston tool along with conventional treatment in first 6 sessions. Apply hot pack for 10 mins on low back as passive warm up then AROM's of Hip (5 reps x 2 sets each) will be performed. Apply Graston tool at 30-60 degrees angle along the length of following muscles Piriformis, Gluteus medius and Hamstrings after applying emollient for 40-120 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Instrument assisted soft tissue mobilization | Experimental | IASTM with Graston tool along with conventional treatment in first 6 sessions. Apply hot pack for 10 mins on low back as passive warm up then AROM's of Hip (5 reps x 2 sets each) will be performed. Apply Graston tool at 30-60 degrees angle along the length of following muscles Piriformis, Gluteus medius and Hamstrings after applying emollient for 40-120 seconds.
Piriformis stretch, SLR, Sciatic nerve stretch (3 reps x 20 sec hold x 2 sets/3 days/week for 2 weeks).
Only Conventional protocol will be followed for remaining 6 sessions. 3 days/ week for 2 weeks. Hot pack will be applied for 10 minutes on low back followed by Strengthening exercises of Hip abductors (Hip abduction with band in sitting, standing, side-lying hip raise), and hip extensors (Gluteal bridges, Prone hip extension, Prone hams curl). (5 reps x 2 sets each/3 days/week for 2 weeks). Receives: Other: Conventional treatment; Other: Instrument assisted soft tissue mobilization |
| Conventional Treatment | Other | Only conventional treatment will be given in this group. Stretching exercises for 6 sessions and strengthening exercises for remaining 6 sessions.
For first 6 sessions, hot pack will be applied for 10 minutes on low back. AROM's of Hip (5 reps x 2 sets each/ 3 days/week for 2 weeks). Piriformis stretch 3 reps x 20 sec hold x 2 sets/ 3 days/week for 2 weeks. SLR (5reps x 10 sec hold x 2 sets/ 3 days/ week for 2 weeks). Sciatic nerve stretch (5 reps x 10 sec hold x 2 sets/ 3 days/ week for 2 weeks).
In next 6 sessions, strengthening exercises will be performed after applying hot pack on low back for 10 minutes in each session. Hip abductors strengthening (Hip abduction with band in sitting, standing, side-lying hip raise) 5reps x 2 sets each/ 3 days/ week for 2 weeks, and hip extensors (Gluteal bridges, Prone hip extension, Prone hams curl). (5 reps x 2 sets each/ 3 days/ week for 2 weeks).
SLR (5 reps x 10 sec hold x 2 sets 3 days/ week for 2 weeks). Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Functional Scale (LEFS)
It is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals. The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities or to monitor the patient over time and to evaluate the effectiveness of an intervention. This scale scores ranges from 0-80 on a 5 point Likert scale. Changes from baseline, 2nd and 4th week LEFS will be taken.
Measured: 4th week
12 item Short Form Survey (SF-12)
It is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. The SF-12 is a shortened version of its predecessor, the SF-36. It consists of 12 item questions measuring quality of life. Changes from baseline, 2nd and 4th week SF-12 will be taken.
Measured: 4th week
Sciatica Bothersomeness Index (SBI)
It is used to measure the participants' level of sciatica. The scale's ratings range from 0 to 6, with higher levels indicating severe sciatica discomfort. Changes from baseline, 2nd and 4th week SBI will be taken.
Measured: 4th week
Secondary outcomes (4)
NPRS
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). NPRS is the most commonly used version which has good test-retest reliability. Changes from baseline, 2nd week and 4th week NPRS will be taken.
Measured: 4th week
ROM of Hip Flexion
Changes from baseline, 2nd week and 4th week Hip flexion will be taken with goniometer.
Measured: 4th week
ROM of Hip Abduction
Changes from baseline, 2nd week and 4th week Hip abduction will be taken with goniometer.
Measured: 4th week
ROM of Hip Internal Rotation
Changes from baseline, 2nd week and 4th week Hip internal rotation will be taken with goniometer.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start10 Jan 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramsha Tariq, Masters, Principal investigator, Senior Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406023
- Sponsor's protocol ID
- 01795
- Status last verified
- May 2024
- First submitted
- 18 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cass SP. Piriformis syndrome: a cause of nondiscogenic sciatica. Curr Sports Med Rep. 2015 Jan;14(1):41-4. doi: 10.1249/JSR.0000000000000110.
PubMed 25574881Kim J, Sung DJ, Lee J. Therapeutic effectiveness of instrument-assisted soft tissue mobilization for soft tissue injury: mechanisms and practical application. J Exerc Rehabil. 2017 Feb 28;13(1):12-22. doi: 10.12965/jer.1732824.412. eCollection 2017 Feb.
PubMed 28349028Seffrin CB, Cattano NM, Reed MA, Gardiner-Shires AM. Instrument-Assisted Soft Tissue Mobilization: A Systematic Review and Effect-Size Analysis. J Athl Train. 2019 Jul;54(7):808-821. doi: 10.4085/1062-6050-481-17. Epub 2019 Jul 19.
PubMed 31322903Burke J, Buchberger DJ, Carey-Loghmani MT, Dougherty PE, Greco DS, Dishman JD. A pilot study comparing two manual therapy interventions for carpal tunnel syndrome. J Manipulative Physiol Ther. 2007 Jan;30(1):50-61. doi: 10.1016/j.jmpt.2006.11.014.
PubMed 17224356Ahmad Siraj S, Dadgal R. Physiotherapy for Piriformis Syndrome Using Sciatic Nerve Mobilization and Piriformis Release. Cureus. 2022 Dec 26;14(12):e32952. doi: 10.7759/cureus.32952. eCollection 2022 Dec.
PubMed 36712711Cheatham SW, Stull KR, Kolber MJ. Roller massage: is the numeric pain rating scale a reliable measurement and can it direct individuals with no experience to a specific roller density? J Can Chiropr Assoc. 2018 Dec;62(3):161-169.
PubMed 30662071Jones A, Sealey R, Crowe M, Gordon S. Concurrent validity and reliability of the Simple Goniometer iPhone app compared with the Universal Goniometer. Physiother Theory Pract. 2014 Oct;30(7):512-6. doi: 10.3109/09593985.2014.900835. Epub 2014 Mar 25.
PubMed 24666408Grovle L, Haugen AJ, Keller A, Natvig B, Brox JI, Grotle M. The bothersomeness of sciatica: patients' self-report of paresthesia, weakness and leg pain. Eur Spine J. 2010 Feb;19(2):263-9. doi: 10.1007/s00586-009-1042-5. Epub 2009 Jun 2.
PubMed 19488793Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
PubMed 10201543Webster KE, Feller JA. Comparison of the short form-12 (SF-12) health status questionnaire with the SF-36 in patients with knee osteoarthritis who have replacement surgery. Knee Surg Sports Traumatol Arthrosc. 2016 Aug;24(8):2620-6. doi: 10.1007/s00167-015-3904-1. Epub 2016 Jan 28.
PubMed 26821809
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Instrument Assisted Soft Tissue Mobilization in Management of Piriformis Syndrome
- ClinicalTrials.gov ID
- NCT06406023
- Acronym / sponsor ID
- 01795
- Conditions
- Piriformis Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 9 May 2024 (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.
This study aims to assess the effectiveness of IASTM on pain, ROM, Disability and Quality of life among Piriformis Syndrome patients. This study will add to the growing body of knowledge as there are very limited researches done in Pakistan using IASTM in patients with Piriformis Syndrome.
Detailed description
Instrument assisted soft tissue mobilization (IASTM) is a skilled intervention that includes the use of specialized tools to manipulate the skin, myofascia, muscles, and tendons by various direct compressive stroke techniques. It has neurophysiological effect as it stimulates mechanosensitive neurons through skin deformation by using instrument. IASTM affects the vascular response to the injured soft tissue, through increasing the blood flow, reduce the stress and strain to the injured areas, decrease inflammation, increase muscle flexibility and strength, increase blood flow, break up scar tissue, promote proper tissue repair, enhance functional movements, accelerates fibroblast activity.
In 2022 there is a study that stated the overall Prevalence of piriformis muscle syndrome which is 18.3%. The Mean±SD of exact BMI were 27.43±6.859. Male and female Pace sign were 14.2% and 18.3% positive respectively.
Positive Prevalence of piriformis muscle syndrome in the general population in Age groups chi-square value is (47.753b) and P- Value (<0.001).
A 2018 study determined that Hip abductor and extensor strengthening along with neural mobilization and piriformis stretching have significant effect on improving hip abductor strength and lower extremity function when compared with neural mobilization and piriformis stretching alone in patients with Piriformis syndrome.
Another study conducted in 2022, showed the effects of IASTM in discogenic Sciatica along with neural mobilization and lumbar traction and concluded that IASTM alleviated pain and impairments in patients with sciatic nerve entrapment. Whereas, this study will assess the effectiveness of IASTM in non discogenic causes of piriformis syndrome.
A 2016 study showed the efficacy of manual therapy interventions for improving the signs and symptoms of carpal tunnel syndrome by comparing 2 manual therapy techniques: Graston Instrument-assisted soft tissue mobilization (GISTM) and soft tissue mobilization for mild to moderate cases of CTS. Results shows improvements in both groups with pain, nerve conduction latencies, wrist strength and ROM. This study will only assess the effectiveness of IASTM on pain, ROM, disability and quality of life among patients with piriformis syndrome.
Reference article showed efficacy by comparing 2 manual therapy techniques, GISTM and STM in management of carpal tunnel syndrome. There is significant improvement in wrist strength and ROM with IASTM application as it increases muscle flexibility and strength, improves blood flow, breaks up adhesions, reduce stress to injured area, enhance functional movements, increase fibroblastic activity and decreases inflammation. Current study will only assess effectiveness of IASTM on pain, ROM, functional disability and QOL among patients with piriformis syndrome. No evidence in previous studies shows efficacy of IASTM with Graston tool in management of piriformis syndrome. Hence, this study will show effectiveness of IASTM on pain, ROM, disability and quality of life in patients with piriformis syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instrument assisted soft tissue mobilization | Experimental | Other: Conventional treatment, Other: Instrument assisted soft tissue mobilizationIASTM with Graston tool along with conventional treatment in first 6 sessions. Apply hot pack for 10 mins on low back as passive warm up then AROM's of Hip (5 reps x 2 sets each) will be performed. Apply Graston tool at 30-60 degrees angle along the length of following muscles Piriformis, Gluteus medius and Hamstrings after applying emollient for 40-120 seconds. Piriformis stretch, SLR, Sciatic nerve stretch (3 reps x 20 sec hold x 2 sets/3 days/week for 2 weeks). Only Conventional protocol will be followed for remaining 6 sessions. 3 days/ week for 2 weeks. Hot pack will be applied for 10 minutes on low back followed by Strengthening exercises of Hip abductors (Hip abduction with band in sitting, standing, side-lying hip raise), and hip extensors (Gluteal bridges, Prone hip extension, Prone hams curl). (5 reps x 2 sets each/3 days/week for 2 weeks). |
| Conventional Treatment | Other | Other: Conventional treatmentOnly conventional treatment will be given in this group. Stretching exercises for 6 sessions and strengthening exercises for remaining 6 sessions. For first 6 sessions, hot pack will be applied for 10 minutes on low back. AROM's of Hip (5 reps x 2 sets each/ 3 days/week for 2 weeks). Piriformis stretch 3 reps x 20 sec hold x 2 sets/ 3 days/week for 2 weeks. SLR (5reps x 10 sec hold x 2 sets/ 3 days/ week for 2 weeks). Sciatic nerve stretch (5 reps x 10 sec hold x 2 sets/ 3 days/ week for 2 weeks). In next 6 sessions, strengthening exercises will be performed after applying hot pack on low back for 10 minutes in each session. Hip abductors strengthening (Hip abduction with band in sitting, standing, side-lying hip raise) 5reps x 2 sets each/ 3 days/ week for 2 weeks, and hip extensors (Gluteal bridges, Prone hip extension, Prone hams curl). (5 reps x 2 sets each/ 3 days/ week for 2 weeks). SLR (5 reps x 10 sec hold x 2 sets 3 days/ week for 2 weeks). |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed patients of Piriformis syndrome.
- Only females will be included in this study.
- Participants aged 30-65 years.
- Pain due to non-discogenic sciatic nerve entrapment in sub gluteal space.
- Pain aggravated by prolonged sitting, lying, standing.
Key exclusion criteria (5 listed)
- Patients with any Intrinsic Etiology such as Haemarthrosis, rheumatoid arthritis or infection.
- Patients with any recent severe trauma, fractures, subluxation or ligament injury.
- Malignancy, Open wound Fracture, DVT, Compartment syndrome, Pregnancy.
- Patients with irreversible nerve damage.
- Patients with lumbar disc herniation or any disc pathology.
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 |
|---|---|---|
| Conventional treatmentHot pack will be applied for 10 minutes. AROM's of Hip (5 reps x 2 sets each). Piriformis stretch 3 reps x 20 sec hold x 2 sets. SLR (5reps x 10 sec hold x 2 sets). Sciatic nerve stretch (5 reps x 10 sec hold x 2 sets) for 3 days/ week for 2 weeks. Strengthening exercises will be performed after 2 weeks of previous intervention of Hip abductors (Hip abduction with band in sitting, standing, side-lying hip raise), and hip extensors (Gluteal bridges, Prone hip extension, Prone hams curl). (5 reps x 2 sets each). SLR (5 reps x 10 sec hold x 2 sets) each exercise will be performed 3 days/ week for 2 weeks. Total treatment protocol will be followed for 4 weeks. Each session will be of 30 minutes. | Other | Conventional Treatment, Instrument assisted soft tissue mobilization |
| Instrument assisted soft tissue mobilizationInstrument assisted soft tissue mobilization IASTM with Graston tool along with conventional treatment in first 6 sessions. Apply hot pack for 10 mins on low back as passive warm up then AROM's of Hip (5 reps x 2 sets each) will be performed. Apply Graston tool at 30-60 degrees angle along the length of following muscles Piriformis, Gluteus medius and Hamstrings after applying emollient for 40-120 seconds. | Other | Instrument assisted soft tissue mobilization |
Primary outcome
Lower Extremity Functional Scale (LEFS)
Time frame: 4th week
It is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals. The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities or to monitor the patient over time and to evaluate the effectiveness of an intervention. This scale scores ranges from 0-80 on a 5 point Likert scale. Changes from baseline, 2nd and 4th week LEFS will be taken.
12 item Short Form Survey (SF-12)
Time frame: 4th week
It is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. The SF-12 is a shortened version of its predecessor, the SF-36. It consists of 12 item questions measuring quality of life. Changes from baseline, 2nd and 4th week SF-12 will be taken.
Sciatica Bothersomeness Index (SBI)
Time frame: 4th week
It is used to measure the participants' level of sciatica. The scale's ratings range from 0 to 6, with higher levels indicating severe sciatica discomfort. Changes from baseline, 2nd and 4th week SBI will be taken.
4 secondary outcomes
NPRS
Time frame: 4th week
ROM of Hip Flexion
Time frame: 4th week
ROM of Hip Abduction
Time frame: 4th week
ROM of Hip Internal Rotation
Time frame: 4th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 25574881Cass SP. Piriformis syndrome: a cause of nondiscogenic sciatica. Curr Sports Med Rep. 2015 Jan;14(1):41-4. doi: 10.1249/JSR.0000000000000110.
- Background: PubMed 28349028Kim J, Sung DJ, Lee J. Therapeutic effectiveness of instrument-assisted soft tissue mobilization for soft tissue injury: mechanisms and practical application. J Exerc Rehabil. 2017 Feb 28;13(1):12-22. doi: 10.12965/jer.1732824.412. eCollection 2017 Feb.
- Background: PubMed 31322903Seffrin CB, Cattano NM, Reed MA, Gardiner-Shires AM. Instrument-Assisted Soft Tissue Mobilization: A Systematic Review and Effect-Size Analysis. J Athl Train. 2019 Jul;54(7):808-821. doi: 10.4085/1062-6050-481-17. Epub 2019 Jul 19.
- Background: PubMed 17224356Burke J, Buchberger DJ, Carey-Loghmani MT, Dougherty PE, Greco DS, Dishman JD. A pilot study comparing two manual therapy interventions for carpal tunnel syndrome. J Manipulative Physiol Ther. 2007 Jan;30(1):50-61. doi: 10.1016/j.jmpt.2006.11.014.
- Background: PubMed 36712711Ahmad Siraj S, Dadgal R. Physiotherapy for Piriformis Syndrome Using Sciatic Nerve Mobilization and Piriformis Release. Cureus. 2022 Dec 26;14(12):e32952. doi: 10.7759/cureus.32952. eCollection 2022 Dec.
- Background: PubMed 30662071Cheatham SW, Stull KR, Kolber MJ. Roller massage: is the numeric pain rating scale a reliable measurement and can it direct individuals with no experience to a specific roller density? J Can Chiropr Assoc. 2018 Dec;62(3):161-169.
- Background: PubMed 24666408Jones A, Sealey R, Crowe M, Gordon S. Concurrent validity and reliability of the Simple Goniometer iPhone app compared with the Universal Goniometer. Physiother Theory Pract. 2014 Oct;30(7):512-6. doi: 10.3109/09593985.2014.900835. Epub 2014 Mar 25.
- Background: PubMed 19488793Grovle L, Haugen AJ, Keller A, Natvig B, Brox JI, Grotle M. The bothersomeness of sciatica: patients' self-report of paresthesia, weakness and leg pain. Eur Spine J. 2010 Feb;19(2):263-9. doi: 10.1007/s00586-009-1042-5. Epub 2009 Jun 2.
- Background: PubMed 10201543Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
- Background: PubMed 26821809Webster KE, Feller JA. Comparison of the short form-12 (SF-12) health status questionnaire with the SF-36 in patients with knee osteoarthritis who have replacement surgery. Knee Surg Sports Traumatol Arthrosc. 2016 Aug;24(8):2620-6. doi: 10.1007/s00167-015-3904-1. Epub 2016 Jan 28.
- 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.
Ramsha Tariq, Masters principal investigator
Senior Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional treatment and Instrument assisted soft tissue mobilization 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 7 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: status not confirmed, as of the sponsor's last update on 9 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neha Noor, Masters (0334-5828241, nehanoor197@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Extremity Functional Scale (LEFS) (time frame: 4th week). 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 NCT06406023, which also lists 10 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 9 May 2024.