NCT04842656

Brief Summary

The purpose of the study is to compare the effects of active release technique and post isometric relaxation in patients with piriformis syndrome on pain, hip internal rotation range of motion and functional disability. A randomized clinical trial was conducted at Shifa Intl. Hospital, Islamabad. The sample size was 26 calculated through open-epi tool but were recruited 30. The participants were divided into two interventional groups each having 15 participants. The study duration was six months. Sampling technique applied was purposive sampling for recruitment and group randomization using sealed envelope method. Only 35 to 55 years participants with diagnosed piriformis syndrome were included in this study. Tools used in this study are Goniometer, Visual Analogue Scale and lower extremity functional scale. Data was collected at baseline, 3 weeks after sessions and after one month follow up. Data was analyzed through SPSS version 20.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
Last Updated

September 20, 2021

Status Verified

September 1, 2021

Enrollment Period

7 months

First QC Date

April 10, 2021

Last Update Submit

September 13, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Analogue Scale

    It is used to measure the intensity or frequency of pain. It ranges on a scale from 0 to 10.

    6 months

  • Goniometer

    Goniometer is an efficient tool to measure hip range of motion. It measures an angle from 0 to 180.

    6 months

  • Lower Extremity Functional Scale

    It is a questionnaire containing 20 questions about a persons ability to perform everyday tasks. It minimum score is 0 and maximum score is 80

    6 months

Study Arms (2)

Active release technique alongwith conventional treatment

EXPERIMENTAL

Patients in Group A will receive active release technique. ART will be applied with patient in prone lying, knee flexed at 90. The therapist will place his elbow tip on taut band of piriformis and direct pressure is applied, patient is then asked to do internal rotation of hip, in order to achieve lengthening of the muscle. This will be repeated 5-7 times(22).

Other: Active release technique alongwith conventional treatment

Post isometric relaxation alongwith conventional treatment

EXPERIMENTAL

Patients in group B will receive post isometric relaxation technique. Patient lying in supine position, with the treated leg is placed into flexion at the hip and knee, so that the foot rests on the table lateral to the contra lateral knee (the leg on the side to be treated is crossed over the other). Therapist places one hand on the contra lateral ASIS to prevent pelvic motion, while the other hand is placed against the lateral flexed knee as this is pushed into resisted abduction to contract piriformis (PIR MET). The starting position will be the 1st sign of resistance towards end range. Therapist Force will be same as patient's force. Initial effort is approximately 20% of patient's strength. Duration of contraction is 7-10 seconds with three repetitions(32)

Other: Post isometric relaxation

Interventions

Patients in group B will receive post isometric relaxation technique. Patient lying in supine position, with the treated leg is placed into flexion at the hip and knee, so that the foot rests on the table lateral to the contra lateral knee (the leg on the side to be treated is crossed over the other). Therapist places one hand on the contra lateral ASIS to prevent pelvic motion, while the other hand is placed against the lateral flexed knee as this is pushed into resisted abduction to contract piriformis (PIR MET). The starting position will be the 1st sign of resistance towards end range. Therapist Force will be same as patient's force. Initial effort is approximately 20% of patient's strength. Duration of contraction is 7-10 seconds with three repetitions

Post isometric relaxation alongwith conventional treatment

Patients in Group A will receive active release technique.ART will be applied with patient in prone lying, knee flexed at 90. The therapist will place his elbow tip on taut band of piriformisand direct pressure isapplied, patient is then asked to do internal rotation of hip, in order to achieve lengthening of the muscle. This will be repeated 5-7 times.

Active release technique alongwith conventional treatment

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic pain in the buttock and hip area
  • Tenderness to palpation over the sciatic notch
  • Positive FABER (flexion, abduction, external rotation),FAIR (flexion, adduction, internal rotation) maneuvers.

You may not qualify if:

  • Malignancies
  • History of steroid therapy
  • Rheumatoid arthritis/ Osteoarthritis
  • Pain medications/ muscle relaxants
  • Osteoporosis
  • Fracture of femur and hip joint dislocation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shifa International Hospital

Islamabad, 44000, Pakistan

Location

Related Publications (32)

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    PMID: 9001677BACKGROUND
  • Yeoman W. The Relation Of Arthritis Of The Sacro-Iliac Joint To Sciatica, With An Analysis Of 100 Cases. The Lancet. 1928;212(5492):1119-23.

    BACKGROUND
  • Hopayian K. Sciatica in the community--not always disc herniation. Int J Clin Pract. 1999 Apr-May;53(3):197-8.

    PMID: 10665132BACKGROUND
  • Reichel G, Gaerisch F Jr. [Piriformis syndrome. A contribution to the differential diagnosis of lumbago and coccygodynia]. Zentralbl Neurochir. 1988;49(3):178-84. German.

    PMID: 2977249BACKGROUND
  • Benson ER, Schutzer SF. Posttraumatic piriformis syndrome: diagnosis and results of operative treatment. J Bone Joint Surg Am. 1999 Jul;81(7):941-9.

    PMID: 10428125BACKGROUND
  • Papadopoulos EC, Khan SN. Piriformis syndrome and low back pain: a new classification and review of the literature. Orthop Clin North Am. 2004 Jan;35(1):65-71. doi: 10.1016/S0030-5898(03)00105-6.

    PMID: 15062719BACKGROUND
  • Kirkaldy-Willis WH, Hill RJ. A more precise diagnosis for low-back pain. Spine (Phila Pa 1976). 1979 Mar-Apr;4(2):102-9. doi: 10.1097/00007632-197903000-00003.

    PMID: 162546BACKGROUND
  • Steiner C, Staubs C, Ganon M, Buhlinger C. Piriformis syndrome: pathogenesis, diagnosis, and treatment. J Am Osteopath Assoc. 1987 Apr;87(4):318-23. No abstract available.

    PMID: 3583849BACKGROUND
  • Pace JB. Commonly overlooked pain syndromes responsive to simple therapy. Postgrad Med. 1975 Oct;58(4):107-13. doi: 10.1080/00325481.1975.11714172. No abstract available.

    PMID: 1099564BACKGROUND
  • Blaser-Sziede R. Piriformissyndrom-kritische Beurteilung der Literatur und Diskussion der klinischen Zusammenhänge. manuelletherapie. 2006;10(04):159-69

    BACKGROUND
  • Benzon HT, Katz JA, Benzon HA, Iqbal MS. Piriformis syndrome: anatomic considerations, a new injection technique, and a review of the literature. Anesthesiology. 2003 Jun;98(6):1442-8. doi: 10.1097/00000542-200306000-00022.

    PMID: 12766656BACKGROUND
  • Hopayian K, Song F, Riera R, Sambandan S. The clinical features of the piriformis syndrome: a systematic review. Eur Spine J. 2010 Dec;19(12):2095-109. doi: 10.1007/s00586-010-1504-9. Epub 2010 Jul 3.

    PMID: 20596735BACKGROUND
  • Durrani Z, Winnie AP. Piriformis muscle syndrome: an underdiagnosed cause of sciatica. J Pain Symptom Manage. 1991 Aug;6(6):374-9. doi: 10.1016/0885-3924(91)90029-4.

    PMID: 1880438BACKGROUND
  • Freiberg AH. Sciatic pain and its relief by operations on muscle and fascia. Archives of Surgery. 1937;34(2):337-50

    BACKGROUND
  • Fishman SM, Caneris OA, Bandman TB, Audette JF, Borsook D. Injection of the piriformis muscle by fluoroscopic and electromyographic guidance. Reg Anesth Pain Med. 1998 Nov-Dec;23(6):554-9. doi: 10.1016/s1098-7339(98)90080-3.

    PMID: 9840849BACKGROUND
  • Kirschner JS, Foye PM, Cole JL. Piriformis syndrome, diagnosis and treatment. Muscle Nerve. 2009 Jul;40(1):10-8. doi: 10.1002/mus.21318.

    PMID: 19466717BACKGROUND
  • Hughes SS, Goldstein MN, Hicks DG, Pellegrini VD Jr. Extrapelvic compression of the sciatic nerve. An unusual cause of pain about the hip: report of five cases. J Bone Joint Surg Am. 1992 Dec;74(10):1553-9. No abstract available.

    PMID: 1469018BACKGROUND
  • Rodrigue T, Hardy RW. Diagnosis and treatment of piriformis syndrome. Neurosurg Clin N Am. 2001 Apr;12(2):311-9.

    PMID: 11525209BACKGROUND
  • Dworkin RH, O'Connor AB, Backonja M, Farrar JT, Finnerup NB, Jensen TS, Kalso EA, Loeser JD, Miaskowski C, Nurmikko TJ, Portenoy RK, Rice ASC, Stacey BR, Treede RD, Turk DC, Wallace MS. Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain. 2007 Dec 5;132(3):237-251. doi: 10.1016/j.pain.2007.08.033. Epub 2007 Oct 24.

    PMID: 17920770BACKGROUND
  • Jankovic D, Peng P, van Zundert A. Brief review: piriformis syndrome: etiology, diagnosis, and management. Can J Anaesth. 2013 Oct;60(10):1003-12. doi: 10.1007/s12630-013-0009-5. Epub 2013 Jul 27.

    PMID: 23893704BACKGROUND
  • Mujawar JC, Chotai K, Kanase S, Jadhav A. Effectiveness of Neuromuscular Therapy and Active Release Technique in Young Adults with Piriformis Tightness. Indian Journal of Physiotherapy & Occupational Therapy. 2019;13(4):212-7

    BACKGROUND
  • Martin HD, Hatem M, Palmer IJ. Endoscopic sciatic nerve decompression: operative technique. Operative Techniques in Sports Medicine. 2012;20(4):325-32

    BACKGROUND
  • Kage V, Ratnam R. Immediate effect of active release technique versus mulligan bent leg raise in subjects with hamstring tightness: a randomized clinical trial. Int J Physiother Res. 2014;2(1):301-4

    BACKGROUND
  • Moore T. Active release technique for iliotibial band syndrome: A case report: Florida Gulf Coast University; 2014

    BACKGROUND
  • Fryer G, Ruszkowski W. The influence of contraction duration in muscle energy technique applied to the atlanto-axial joint. Journal of osteopathic medicine. 2004;7(2):79-84

    BACKGROUND
  • El Laithy M, Fouda K. Effect of post isometric relaxation technique in the treatment of mechanical neck pain. Physical Therapy and Rehabilitation. 2018;5(1):20

    BACKGROUND
  • Tak S, Lee Y, Choi W, Lee G. The effects of active release technique on the gluteus medius for pain relief in persons with chronic low back pain. Physical Therapy Rehabilitation Science. 2013;2(1):27-30

    BACKGROUND
  • Mahakul B. Effectiveness Of Post Isometric Relaxation Technique And Stretching In Functional Outcome On Piriformis Syndrome: A Randomized Experimental Study 2010

    BACKGROUND
  • Aleksiev A, Kraev T. Postisometric relaxation versus high velocity low amplitude techniques in low back pain. Journal of Orthopaedic Medicine. 2007;29(3):105-8

    BACKGROUND
  • Bose Gnsc, Dusad G. Effect Of Reciprocal Inhibition And Post Isometric Relaxation; Types Of Muscle Energy Technique In Piriformis Syndrome-A Comparative Study

    BACKGROUND
  • Kim JH, Lee HS, Park SW. Effects of the active release technique on pain and range of motion of patients with chronic neck pain. J Phys Ther Sci. 2015 Aug;27(8):2461-4. doi: 10.1589/jpts.27.2461. Epub 2015 Aug 21.

    PMID: 26357426BACKGROUND
  • 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: 10201543BACKGROUND

MeSH Terms

Conditions

Piriformis Muscle Syndrome

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic Pain

Study Officials

  • Lal Gul Khan, MScPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparison of Active Release Technique and Post Isometric Relaxation in patients with Piriformis Syndrome
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2021

First Posted

April 13, 2021

Study Start

June 30, 2020

Primary Completion

January 20, 2021

Study Completion

February 26, 2021

Last Updated

September 20, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations