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

NCT06406023 | Recruiting

• 1 other identifier: 01795
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Piriformis Syndrome

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  4th week

Secondary Outcomes (4)

• NPRS

  4th week

• ROM of Hip Flexion

  4th week

• ROM of Hip Abduction

  4th week

• ROM of Hip Internal Rotation

  4th week

Study Arms (2)

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).

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).

Other: Conventional treatment

Interventions

Conventional treatment OTHER

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.

Conventional Treatment; Instrument assisted soft tissue mobilization

Instrument assisted soft tissue mobilization OTHER

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.

Instrument assisted soft tissue mobilization

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Tool will be applied on Piriformis, Hamstrings and Gluteus medius muscles. Considering ethical values only female participants will be included in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

RECRUITING

Related Publications (10)

• Cass SP. Piriformis syndrome: a cause of nondiscogenic sciatica. Curr Sports Med Rep. 2015 Jan;14(1):41-4. doi: 10.1249/JSR.0000000000000110.

  PMID: 25574881 BACKGROUND

• 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.

  PMID: 28349028 BACKGROUND

• 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.

  PMID: 31322903 BACKGROUND

• 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.

  PMID: 17224356 BACKGROUND

• 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.

  PMID: 36712711 BACKGROUND

• Cheatham 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.

  PMID: 30662071 BACKGROUND

• Jones 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.

  PMID: 24666408 BACKGROUND

• Grovle 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.

  PMID: 19488793 BACKGROUND

• 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.

  PMID: 10201543 BACKGROUND

• Webster 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.

  PMID: 26821809 BACKGROUND

MeSH Terms

Conditions

Piriformis Muscle Syndrome

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Study Officials

• Ramsha Tariq, Masters

  Senior Lecturer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neha Noor, Masters

CONTACT

0334-5828241; nehanoor197@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: May 9, 2024
• Study Start: January 10, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)