Muscle Energy Techniques and Sacral Manipulation on Pain, Functional Disability and Quality of Life

NCT05018780 | Completed

• 1 other identifier: IRB-UOL-FAHS/885/2021
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

• The study will be randomized clinical trial. This study will be conducted in University of Lahore Teaching Hospital, Lahore, Pakistan. A sample size of 84 will be randomly allocated into two experimental groups, (42 participants in each group), by lottery method. The participants, randomly allocated to the experimental group A, will receive Muscle Energy Technique (METs), Post isometric relaxation technique specifically, in addition with routine physical therapy as TENS, Hot pack, and strengthening exercises. METs will be performed on piriformis, iliopsoas, erector spine muscles, 1 set of 5 repetitions and 10 seconds hold.
• Participants in experimental group B, will get Sacroiliac joint manipulations with routine physical therapy by principal investigator.
• Both experimental groups will receive twelve treatment sessions and those will be given over a period of six weeks (2 sessions per week, each session of 30-40 minutes).
• Assessor will take outcome measures at baseline and at the end of 6th treatment week through Short Form McGill Pain Questionnaire, Roland-Morris Low Back Pain \& Disability Questionnaire and Short Form Survey; SF-20.

Conditions

Sacroiliac Joint Dysfunction

Keywords

Sacroilitis

Outcome Measures

Primary Outcomes (3)

• Short Form McGill Pain Questionnaire

  Short form McGill Pain questionnaire (SF-MPQ 2) is 22-items, revised, short version and self-reported measure of pain. It assesses both the quality and intensity of subjective pain. It was initially developed by Dr. Melzack at McGill University in Montreal Canada. The four SF-MPQ-2 score ranges between 0 to 22 where o indicate no pain and 22 indicate worst possible pain.

  6 weeks

• Roland Morris disability and low back pain questionnaire

  he Roland-Morris Questionnaire (RMQ) is a 24-items self-administered disability measure. Items would be scored 0 if left blank or 1 if endorsed, for a total RMQ score ranging from 0 to 24; higher scores will be represented as higher levels of pain-related disability.

  6 weeks

• Short Form Survey, SF-20

  The SF-20 is short version of SF-36 which is generic patient-reported outcome that qualifies health status and measures health related quality of life. The 20-Item Short Form Health Survey (SF-20) was developed in 1988 for the Medical Outcomes Study (MOS). In this scale, scores across each of its domains would be reported on a 0% to 100% scale, with 0% representing the worst possible score in that domain and 100% the best possible score. The exception to this scoring pattern would be the pain score, for which 0% will represent the best possible score and 100% the worst possible.

  6 weeks

Study Arms (2)

Muscle Energy Technique

EXPERIMENTAL

Post isometric relaxation: Patient will perform isometrics on piriformis, iliopsoas and erector spinae muscles one by one. Each isometric contraction will be held for 10 seconds and than participants will be asked to relax the contraction with an exhalation. This will be repeated five times in one session. \- Routine physical therapy including TENS, Hot pack and strengthening exercises will also be delivered along with Muscle Energy Technique.

Other: Muscle Energy Technique

Sacral Manipulation

EXPERIMENTAL

* To manipulate an iliac anterior rotation displacement sacroiliac joint dysfunction and to restore posterior rotation of the ilium, participant will be positioned in side lying. Therapist will place one hand at Anterior superior iliac supine (ASIS) and the other at Ischial tuberosity. A quick thrust will be applied and ASIS will be pushed posteriorly while Ischial tberosity anteriorly. This will be maintained for 10 to 30 seconds. * To manipulate an iliac posterior rotation displacement sacroiliac joint dysfunction and to restore anterior rotation of the ilium, participant will be in prone position. One hand of therapist will be at Posterior superior iliac supine (PSIS) and the other one at pubic rami. A quick thrust will be delivered and PSIS will be moved anteriorly while pubic rami posteriorly. This will be maintained for 10 to 30 seconds. * Routine physical therapy including TENS, Hot pack and strengthening exercises will also be delivered along with Sacral Manipulation.

Other: Sacral Manipulation

Interventions

Muscle Energy Technique OTHER

Post isometric relaxation: Patient will be asked to perform isometrics on piriformis, iliopsoas and erector spinae muscles one by one. Each isometric contraction will be held for 10 seconds. After 10 seconds, contraction will be released with an exhalation. These contractions will be repeated for 5 times in one session. Routine physical therapy including TENS, Hot pack and strengthening exercises will also be delivered along with Muscle Energy Technique.

Muscle Energy Technique

Sacral Manipulation OTHER

* To manipulate an iliac anterior rotation displacement sacroiliac joint dysfunction and to restore posterior rotation of the ilium, participant will be positioned in side lying. Therapist will place one hand at Anterior superior iliac supine (ASIS) and the other at Ischial tuberosity. A quick thrust will be applied and ASIS will be pushed posteriorly while Ischial tberosity anteriorly. This will be maintained for 10 to 30 seconds. * To manipulate an iliac posterior rotation displacement sacroiliac joint dysfunction and to restore anterior rotation of the ilium, participant will be in prone position. One hand of therapist will be at Posterior superior iliac supine (PSIS) and the other one at pubic rami. A quick thrust will be delivered and PSIS will be moved anteriorly while pubic rami posteriorly. This will be maintained for 10 to 30 seconds. * Routine physical therapy including TENS, Hot pack and strengthening exercises will also be delivered along with Sacral Manipulation.

Sacral Manipulation

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pre-diagnosed cases referred from orthopedic surgeon
• History of fall on buttock, lift and twist maneuver, overzealous kick
• Acute onset of sacral pain within period of 6 weeks
• FABER, Thigh thrust and Gillet sacral joint diagnostic tests must be positive to confirm the SI joint dysfunction before allocation

You may not qualify if:

• General low back pain, Sciatic pain, piriformis syndrome, Hip joint pathology
• SI joint spondylosis or ankylosing spondylitis
• Red flag signs positive (constant pain without movement, sudden weight loss with pain in time, lower limbs' undefined weakness, neurological signs)
• Structural leg length discrepancy and recent pregnancy
• Participants with other spinal pathologies (e.g. Osteomyelitis, Pott's disease, Cauda equine syndrome, spondylolisthesis or spondyloptosis, Lumbar disc herniation etc.)
• Participants with other systemic illnesses (e.g. cardiovascular disorders, gastrointestinal disorders, renal function disorders, Liver function disorders etc.)
• Participants with traumatic injuries (e.g. fractures, dislocations, sports injuries, road traffic accidents)

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

University of Lahore Teaching Hospital

Lahore, Punjab Province, 55150, Pakistan

Location

Related Publications (9)

• Telli H, Huner B, Kuru O. Determination of the Prevalence From Clinical Diagnosis of Sacroiliac Joint Dysfunction in Patients With Lumbar Disc Hernia and an Evaluation of the Effect of This Combination on Pain and Quality of Life. Spine (Phila Pa 1976). 2020 Apr 15;45(8):549-554. doi: 10.1097/BRS.0000000000003309.

  PMID: 31842104 BACKGROUND

• Thawrani DP, Agabegi SS, Asghar F. Diagnosing Sacroiliac Joint Pain. J Am Acad Orthop Surg. 2019 Feb 1;27(3):85-93. doi: 10.5435/JAAOS-D-17-00132.

  PMID: 30278010 BACKGROUND

• Orakifar N, Kamali F, Pirouzi S, Jamshidi F. Sacroiliac joint manipulation attenuates alpha-motoneuron activity in healthy women: a quasi-experimental study. Arch Phys Med Rehabil. 2012 Jan;93(1):56-61. doi: 10.1016/j.apmr.2011.05.027.

  PMID: 22200384 BACKGROUND

• Garcia-Penalver UJ, Palop-Montoro MV, Manzano-Sanchez D. Effectiveness of the Muscle Energy Technique versus Osteopathic Manipulation in the Treatment of Sacroiliac Joint Dysfunction in Athletes. Int J Environ Res Public Health. 2020 Jun 22;17(12):4490. doi: 10.3390/ijerph17124490.

  PMID: 32580480 BACKGROUND

• Zaidi F, Ahmed I. Effectiveness of muscle energy technique as compared to Maitland mobilisation for the treatment of chronic sacroiliac joint dysfunction. J Pak Med Assoc. 2020 Oct;70(10):1693-1697. doi: 10.5455/JPMA.43722.

  PMID: 33159735 BACKGROUND

• de Toledo DFA, Kochem FB, Silva JG. High-velocity, low-amplitude manipulation (HVLA) does not alter three-dimensional position of sacroiliac joint in healthy men: A quasi-experimental study. J Bodyw Mov Ther. 2020 Jan;24(1):190-193. doi: 10.1016/j.jbmt.2019.05.020. Epub 2019 May 22.

  PMID: 31987543 BACKGROUND

• Stratford PW, Riddle DL. A Roland Morris Disability Questionnaire Target Value to Distinguish between Functional and Dysfunctional States in People with Low Back Pain. Physiother Can. 2016;68(1):29-35. doi: 10.3138/ptc.2014-85.

  PMID: 27504045 BACKGROUND

• Dworkin RH, Turk DC, Trudeau JJ, Benson C, Biondi DM, Katz NP, Kim M. Validation of the Short-form McGill Pain Questionnaire-2 (SF-MPQ-2) in acute low back pain. J Pain. 2015 Apr;16(4):357-66. doi: 10.1016/j.jpain.2015.01.012. Epub 2015 Jan 29.

  PMID: 25640290 BACKGROUND

• Nejati P, Sartaj E, Imani F, Moeineddin R, Nejati L, Safavi M. Accuracy of the Diagnostic Tests of Sacroiliac Joint Dysfunction. J Chiropr Med. 2020 Mar;19(1):28-37. doi: 10.1016/j.jcm.2019.12.002. Epub 2020 Sep 12.

  PMID: 33192189 BACKGROUND

Study Officials

• Hafiza Sana Ashraf, MS-MSK*

  University of Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study will be single and assessor blinded. Participants will be masked about other groups but they will know what treatment they will be receiving or what exercises they will be doing. Principal investigator would also not be masked or blinded because investigator would be applying the techniques on participants of both group. So participant and and principal investigator cannot be blinded. Only assessor will be blinded and he will take outcome measures without knowing the problem and treatment techniques.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 24, 2021
• Study Start: July 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: October 2, 2025

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)