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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06460675
Other study ID # REC/RCR & AHS/23/01114
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date November 10, 2024

Study information

Verified date June 2024
Source Riphah International University
Contact Mateen Asghar, MS-DPT
Phone 03046368317
Email mateen04443@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the effects of Autogenic Inhibition and Reciprocal Inhibition Muscle Energy Techniques (METS) in Piriformis Syndrome


Description:

Piriformis syndrome is when the piriformis muscle, located in the buttock region, spasms and causes buttock pain. The piriformis muscle also can irritate the nearby sciatic nerve and cause pain, numbness, and tingling along the back of the leg and into the foot (similar to sciatic pain). The functional limitations experienced by hip pain patients in the lower limb profoundly impact their quality of life. This study aims to investigate the effectiveness of an integrated approach that compares the Effects of Autogenic Inhibition versus Reciprocal Inhibition Muscle Energy Techniques on Pain, Range of motion, and Disability in patients with Piriformis Syndrome. This randomized clinical trial will be conducted at DHQ Hospital Jhang over six months. The sample size will consist of 32 participants. Participants who meet the inclusion criteria will be taken through a non-probability convenience sampling technique, that will be randomized through a sealed envelope method. 16 Participants will be assigned to Group A that will be treated with the Autogenic Inhibition Muscle Energy Technique, 16 Participants will be assigned to Group B and will be treated with Reciprocal Inhibition Muscle Energy Technique at the frequency of 1 set and 3 repetitions per session for two sessions per week and total six sessions for three weeks with follow up at one month. The duration of contraction is 7-10 seconds. Pre and post-intervention values will be taken on the 1st day in the 3rd week and at one-month follow-up. Data will be collected using various assessment tools, including the FAIR test, Freiberg test, Lasegue test, Beatty test, Pace sign, Numeric Pain Rating Scale (NPRS), and Universal Goniometer. Pre-intervention assessments will be conducted for all two groups. The effects of the interventions will be measured either by parametric or non-parametric tests after assessing the normality of data by the Shapiro-Wilk test Independent t-test. Data analysis will be performed by using SPSS 25 software.


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date November 10, 2024
Est. primary completion date October 10, 2024
Accepts healthy volunteers No
Gender All
Age group 25 Years to 45 Years
Eligibility Inclusion Criteria: - Both genders with ages between 25-45 years. - Patients diagnosed with Piriformis syndrome using the Piriformis FAIR test, Freiberg test, Lasegue test, Beaty test, and pace sign. - Hip pain with a threshold of NPRS 3-6. - Limited ROM of Hip Internal Rotation and Abduction measured using a goniometer. - Buttock pain = 3 months. - Pain with prolonged sitting (more than 20 minutes) Exclusion Criteria: - Hip Degenerative changes. - History of Trauma or Fracture - Other Systemic Conditions - Postural abnormality/deformity - Diagnosed Psychological Disorders - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Autogenic Inhibition Muscle Energy Technique
No of repetitions: 1 set with 3 repetitions No of Sessions per week: 2 per weeks for 3 weeks (40 Min per Session)
Reciprocal Inhibition Muscle Energy Technique
No of repetitions: 1 set with 3 repetitions No of Sessions per week: 2 per week for 3 weeks (40 Min per Session)

Locations

Country Name City State
Pakistan IIMCT Railway General Hospital Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

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. — View Citation

Chang C, Jeno SH, Varacallo M. Anatomy, Bony Pelvis and Lower Limb: Piriformis Muscle. 2023 Nov 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK519497/ — View Citation

Hopayian K, Danielyan A. Four symptoms define the piriformis syndrome: an updated systematic review of its clinical features. Eur J Orthop Surg Traumatol. 2018 Feb;28(2):155-164. doi: 10.1007/s00590-017-2031-8. Epub 2017 Aug 23. — View Citation

Islam F, Mansha H, Gulzar K, Raza A, Raffique A, Haider S. Prevalence Of Piriformis Muscle Syndrome Among Individuals with Low Back Pain: Piriformis Muscle Syndrome Among Individuals with Low Back Pain. Pakistan Journal of Health Sciences. 2022:48-52.

Probst D, Stout A, Hunt D. Piriformis Syndrome: A Narrative Review of the Anatomy, Diagnosis, and Treatment. PM R. 2019 Aug;11 Suppl 1:S54-S63. doi: 10.1002/pmrj.12189. Epub 2019 Jul 22. — View Citation

Sadiq M, Hussain SA, Meganath P. 'Hand on hip'sign: A novel screening test and diagnostic tool in piriformis syndrome. Journal of Orthopaedics, Trauma and Rehabilitation. 2020:2210491720961113.

Siahaan YMT, Ketaren RJ, Hartoyo V, Tiffani P. The predisposing factors of piriformis syndrome: Study in a referral hospital. MNJ (Malang Neurology Journal). 2019;5(2):76-9.

Siahaan YMT, Tiffani P, Tanasia A. Ultrasound-Guided Measurement of Piriformis Muscle Thickness to Diagnose Piriformis Syndrome. Front Neurol. 2021 Sep 7;12:721966. doi: 10.3389/fneur.2021.721966. eCollection 2021. — View Citation

Tanveer F, Shahid S. Frequency of Piriformis tightness in professionals middle aged women. Rawal Medical Journal. 2018;43(4):685-.

Wu YY, Guo XY, Chen K, He FD, Quan JR. Feasibility and Reliability of an Ultrasound Examination to Diagnose Piriformis Syndrome. World Neurosurg. 2020 Feb;134:e1085-e1092. doi: 10.1016/j.wneu.2019.11.098. Epub 2019 Nov 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain : Numeric Pain Rating Scale (NPRS) Patients' overall assessment of pain will be provided using the numeric pain rating scale 3 Weeks
Primary Range of Motion : Universal Goniometer It is frequently employed as a benchmark technique for the assessment of Range of Motion 3 Weeks
Primary Lower Extremity Functional Scale (LEFS) The LEFS is a self-report questionnaire intended to assess functional status in patients with disability of the lower extremity (e.g., hip, thigh, ankle) containing 20 questions about a person's ability to perform everyday tasks 3 Weeks
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