NCT05356390

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

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

First Submitted

Initial submission to the registry

April 28, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

May 2, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2022

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

April 28, 2022

Last Update Submit

November 8, 2022

Conditions

Keywords

paindisability physicalmuscle strength

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Stabilization exercises

EXPERIMENTAL

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.

Other: Stabilization exercises

Muscle energy techniques

ACTIVE COMPARATOR

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.

Other: Muscle energy techniques

Interventions

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.

Stabilization exercises

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.

Muscle energy techniques

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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:
  • Sacroiliac Distraction (Gapping) Test
  • Thigh Thrust Test
  • Sacroiliac Compression (Squish) Test
  • 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.

You may not qualify if:

  • Trochanteric bursitis
  • Pelvic bone fracture
  • Pelvic implants
  • Pregnancy
  • Lumbosacral disc herniation
  • Sacroiliac joint inflammation
  • Inflammatory bowel disease
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakhtawar Amin hospital Multan

Multan Khurd, Punjab Province, 60650, Pakistan

Location

Related Publications (10)

  • 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.

    PMID: 33256545BACKGROUND
  • 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.

    PMID: 34539068BACKGROUND
  • 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.

    PMID: 26889985BACKGROUND
  • Barros G, McGrath L, Gelfenbeyn M. Sacroiliac Joint Dysfunction in Patients With Low Back Pain. Fed Pract. 2019 Aug;36(8):370-375.

    PMID: 31456628BACKGROUND
  • 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.

    PMID: 23253394BACKGROUND
  • 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.

    PMID: 33641272BACKGROUND
  • 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.

    PMID: 33654504BACKGROUND
  • 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: 32580480BACKGROUND
  • 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.

    PMID: 31992024BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • samrood Akram, MPhil

    Riphah International University,Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 2, 2022

Study Start

May 2, 2022

Primary Completion

September 30, 2022

Study Completion

October 5, 2022

Last Updated

November 9, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations