Sacroiliac Joint Dysfunction Clinical Trial
Official title:
Immediate and Long Term Effects of Muscle Energy Techniques and Sacral Manipulation on Pain, Functional Disability and Quality of Life in Patients With Sacroiliac Joint Dysfunction: A Randomized Clinical Trial
Verified date | December 2021 |
Source | University of Lahore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
- 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.
Status | Completed |
Enrollment | 76 |
Est. completion date | October 11, 2021 |
Est. primary completion date | October 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 40 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Pakistan | University of Lahore Teaching Hospital | Lahore | Punjab |
Lead Sponsor | Collaborator |
---|---|
University of Lahore |
Pakistan,
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. — View Citation
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. — View Citation
García-Peñalver UJ, Palop-Montoro MV, Manzano-Sánchez 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). pii: E4490. doi: 10.3390/ijerph17124490. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Telli H, Hüner B, Kuru Ö. 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. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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