Effectiveness of Instrument Assisted Soft Tissue Mobilization in Management of Piriformis Syndrome

Not Applicable

Recruiting

• Conditions: Piriformis Syndrome
• Interventions: Other: Conventional treatment; Other: Instrument assisted soft tissue mobilization

• Registration Number: NCT06406023
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study Start: 2024-01-10
• Study First Submitted: 2024-04-18
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-06
• Last Update Submitted: 2024-05-06
• Study First Posted: 2024-05-09
• Last Update Posted: 2024-05-09
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 38

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Instrument assisted soft tissue mobilization	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. 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).
Instrument assisted soft tissue mobilization	Conventional treatment	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).
Conventional Treatment	Conventional treatment	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).

Primary Outcome Measures

Name	Time	Method
Lower Extremity Functional Scale (LEFS)	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
ROM of Hip Abduction	4th week	Changes from baseline, 2nd week and 4th week Hip abduction will be taken with goniometer.
ROM of Hip Internal Rotation	4th week	Changes from baseline, 2nd week and 4th week Hip internal rotation will be taken with goniometer.
NPRS	4th week	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.
ROM of Hip Flexion	4th week	Changes from baseline, 2nd week and 4th week Hip flexion will be taken with goniometer.

Trial Locations

Locations (1)

Railway General Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan