Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05356390
Other study ID # REC/Lhr/22/0107 Sana
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2, 2022
Est. completion date October 5, 2022

Study information

Verified date November 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Sacroiliac joint is in pelvis. It links the iliac bone (pelvic) bone to the sacrum. This joint pain is due to hyper mobility or instability of the joint, it may also cause by damage to joint between the spine and hip. This pain is typically felt in the lower back, or hip and may radiate to groin area. The aim of this study will be to compare the effects of stabilization exercises and muscle energy techniques on pain and disability in patients with sacroiliac joint pain.


Description:

A randomized clinical trial will be conducted at Ibn- e- Siena hospital and research institute Multan and in Bakhtawar Amin hospital Multan through convenience sampling technique on 30 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. After giving common treatment of hot pack and transcutaneous electrical stimulation and assessing pre-treatment patient's condition Group A will be treated with stabilization exercises in which iliopsoas, gluteal and hamstring muscles will be stabilized. Total twelve sessions will be given as three sets three times per week for four weeks. Group B will be treated with muscle energy technique, this is active form of manual therapy in which patient will exert force against physiotherapist force through autogenic inhibition and reciprocal inhibition. (20% patient force against that applied by the physiotherapist and hold contractions for 10 seconds over 5 to 12 repetitions, 3 times per week for 4 weeks). Post-treatment assessment will be done after one month. Outcome measure will be conducted through pain and disability questionnaire after 6 weeks. Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro -Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. Stabilization exercises and muscle energy techniques will be applied for comparing their effectiveness in patients with sacroiliac joint pain.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date October 5, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 30 Years to 50 Years
Eligibility Inclusion Criteria: - Both men and women age between 30-50 with positive Laslett's criteria. The Cluster of Laslett is a group of four test used for sacroiliac joint pain, the four tests are: 1. Sacroiliac Distraction (Gapping) Test 2. Thigh Thrust Test 3. Sacroiliac Compression (Squish) Test 4. Sacral Thrust test - If a patient has three or more positive pain provocation tests, and then there is a 59% chance that the patient will have Sacroiliac joint pain. Exclusion Criteria: - Trochanteric bursitis - Pelvic bone fracture - Pelvic implants - Pregnancy - Lumbosacral disc herniation - Sacroiliac joint inflammation - Inflammatory bowel disease - Malignancy

Study Design


Related Conditions & MeSH terms

  • Sacroiliac Joint Somatic Dysfunction

Intervention

Other:
Stabilization exercises
Stabilization training is an active form of physical therapy designed to strengthen muscles to support the spine and help prevent lower back pain. Group A performed stabilization exercises for 4 weeks. In stabilization exercises, floor bridging, heel prop and alternate arm and leg exercises were administered in iliopsoas, gluteal and hamstring groups. On eligible participants baseline assessment was done,3 sessions were given 3days per week, post intervention assessment was taken at 4th week.
Muscle energy techniques
Muscle Energy Technique (MET) is a is a form of manual therapy, widely used in Osteopathy, that uses a muscle's own energy in the form of gentle isometric contractions to relax the muscles via autogenic or reciprocal inhibition and lengthen the muscle. Muscle energy techniques were given to group B. These techniques are active form of manual therapy in which patient uses its own energy on request to aid in treatment. On eligible participants baseline assessment was done,3 sessions were given 3days per week, post intervention assessment was taken at 4th week.

Locations

Country Name City State
Pakistan Bakhtawar Amin hospital Multan Multan Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

Ahmed UA, Maharaj SS, Van Oosterwijck J. Effects of dynamic stabilization exercises and muscle energy technique on selected biopsychosocial outcomes for patients with chronic non-specific low back pain: a double-blind randomized controlled trial. Scand J Pain. 2021 Feb 24;21(3):495-511. doi: 10.1515/sjpain-2020-0133. Print 2021 Jul 27. — View Citation

Barros G, McGrath L, Gelfenbeyn M. Sacroiliac Joint Dysfunction in Patients With Low Back Pain. Fed Pract. 2019 Aug;36(8):370-375. — View Citation

Cho HJ, Kwak DS. Movement of the sacroiliac joint: Anatomy, systematic review, and biomechanical considerations. Proc Inst Mech Eng H. 2021 Mar;235(3):357-364. doi: 10.1177/0954411920978021. Epub 2020 Nov 30. — View Citation

Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99-116. doi: 10.1586/ern.12.148. Review. — 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

Rashbaum RF, Ohnmeiss DD, Lindley EM, Kitchel SH, Patel VV. Sacroiliac Joint Pain and Its Treatment. Clin Spine Surg. 2016 Mar;29(2):42-8. doi: 10.1097/BSD.0000000000000359. Review. — View Citation

Sanika V, Prem V, Karvannan H. Comparison of Glutues Maximus Activation to Flexion Bias Exercises Along with MET Technique in Subjects with Anterior Rotated Sacroiliac Joint Dysfunction-a Randomised Controlled Trial. Int J Ther Massage Bodywork. 2021 Mar 1;14(1):30-38. eCollection 2021 Mar. — View Citation

Sarkar M, Goyal M, Samuel AJ. Comparing the Effectiveness of the Muscle Energy Technique and Kinesiotaping in Mechanical Sacroiliac Joint Dysfunction: A Non-blinded, Two-Group, Pretest-Posttest Randomized Clinical Trial Protocol. Asian Spine J. 2021 Feb;15(1):54-63. doi: 10.31616/asj.2019.0300. Epub 2020 Jan 30. — View Citation

Sasaki T, Kurosawa D, Murakami E, Watanabe T. Physical therapeutic options for residual sacrotuberous ligament pain after treatment of sacroiliac joint dysfunction. J Phys Ther Sci. 2021 Sep;33(9):646-652. doi: 10.1589/jpts.33.646. Epub 2021 Sep 1. — View Citation

Vaseghnia A, Shadmehr A, Attarbashi Moghadam B, Olyaei G, Hadian Rasanani DM-R, Khazaeipour Z. Effects of Muscle Energy Technique on Daily Activities and Lumbar Stiffness in Women With Sacroiliac Joint Dysfunction: A Randomized Controlled Clinical Trial Study. Journal of Modern Rehabilitation. 2019;13:23-30.

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Pain Rating Scale (NPRS) The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults, including those with chronic pain.
The NPRS is a segmented numeric version in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain.
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
The NPRS takes <1 minute to complete The NPRS is a valid and reliable scale to measure pain intensity;
High test-retest reliability has been (r = 0.96 and 0.95, respectively)
For construct validity, the NPRS was shown to be highly correlated: correlations range from 0.86 to 0.95.
follow up at 4th week
Primary Modified Oswestry disability index This questionnaire has been designed to give us information as to how your back or leg pain is affecting your ability to manage in everyday life. Please answer by checking ONE box in each section for the statement which best applies to you. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5.
follow up at 4th week
See also
  Status Clinical Trial Phase
Completed NCT05181579 - Efficacy of Manual Therapy and Sacroiliac Joint Injection in Sacroiliac Joint Dysfunction N/A
Withdrawn NCT03230279 - Sacroiliac Joint Fusion Comparison Study N/A
Recruiting NCT01311479 - Osteopathic Manipulation for Female Interstitial Cystitis Patients With Sacroiliac Joint Dysfunction N/A
Recruiting NCT05432453 - The Relationship Between Functional Constipation and Sacroiliac Joint Dysfunction
Active, not recruiting NCT03507049 - Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain N/A
Not yet recruiting NCT05404451 - Comparison of Mulligan Mobilization Technique and Mckenzie Exercises Among Patient With Sacroilliac Joint Dysfunction N/A
Withdrawn NCT04534829 - Fluoroscopic vs Ultrasound Guided Sacroiliac (SI) Joint Radiofrequency Ablation Phase 3
Completed NCT04519840 - Diastasis Recti Abdominis Association With Sacroiliac Joint and Pelvic Floor Dysfunction in Postpartum C-section Women
Recruiting NCT04829513 - Exercise and Two Different Kinesiotape Applications in Patients With Sacroiliac Joint Dysfunction
Completed NCT04717401 - Comparison Between Strain-counterstrain and Muscle Energy Technique in Sacroiliac Joint Dysfunction N/A
Terminated NCT04218838 - Comparison of CornerLoc SI Joint Stabilization and Steroid Injections for Sacroiliac Joint Dysfunction N/A
Completed NCT05347537 - Effects of Mulligan's Mobilization With and Without Clamshell Exercises in Sacroiliac Joint Dysfunction N/A
Recruiting NCT04381208 - Medical Record, Physical and Neurological Data That Orient to the Diagnosis of Sacroiliac Joint Dysfunction
Recruiting NCT05944861 - Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections N/A