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

NCT ID: NCT06406023

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-10

Study Completion Date

2024-06-30

Brief Summary

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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

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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

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Piriformis Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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).

Group Type EXPERIMENTAL

Conventional treatment

Intervention Type 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.

Instrument assisted soft tissue mobilization

Intervention Type 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.

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).

Group Type OTHER

Conventional treatment

Intervention Type 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.

Interventions

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Conventional treatment

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ramsha Tariq, Masters

Role: PRINCIPAL_INVESTIGATOR

Senior Lecturer

Locations

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Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Neha Noor, Masters

Role: CONTACT

0334-5828241

Facility Contacts

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Ramsha Tariq, Masters

Role: primary

0331-5251422

References

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

Reference Type BACKGROUND
PMID: 25574881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28349028 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31322903 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17224356 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36712711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30662071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24666408 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19488793 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10201543 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26821809 (View on PubMed)

Other Identifiers

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01795

Identifier Type: -

Identifier Source: org_study_id

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