Clinical trial NCT06406023: Effectiveness of Instrument Assisted Soft Tissue Mobilization in Management of Piriformis Syndrome
Official title: Effectiveness of Instrument Assisted Soft Tissue Mobilization in Management of Piriformis Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Piriformis Syndrome
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 38
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: 4th week
measure: 12 item Short Form Survey (SF-12)
timeFrame: 4th week
measure: Sciatica Bothersomeness Index (SBI)
timeFrame: 4th week
Secondary outcomes:
measure: NPRS
timeFrame: 4th week
measure: ROM of Hip Flexion
timeFrame: 4th week
measure: ROM of Hip Abduction
timeFrame: 4th week
measure: ROM of Hip Internal Rotation
timeFrame: 4th week
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Railway General Hospital
state: Punjab
Study officials:
affiliation: Senior Lecturer
name: Ramsha Tariq, Masters
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cass SP. Piriformis syndrome: a cause of nondiscogenic sciatica. Curr Sports Med Rep. 2015 Jan;14(1):41-4. doi: 10.1249/JSR.0000000000000110.
citation: Kim 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.
citation: Seffrin 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.
citation: Burke 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.
citation: Ahmad 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.
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citation: Binkley 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.
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