NCT05181579CompletedNot Applicable
Efficacy of Manual Therapy and Sacroiliac Joint Injection in the Treatment of Patients With Sacroiliac Joint Dysfunction
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital2 sites in 2 countries30 target enrollmentStarted: September 29, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Numeric Rating Scale, NRS
Study Overview
Brief Summary
The purpose of this study is to compare the efficacy of manual therapy and sacroiliac joint injections in patients with sacroiliac joint dysfunction
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Low back and/or gluteal pain and/or groin pain without radicular extension below the L4 level for more than 3 months
- •Pain score greater than 3 according to NRS
- •Unresponsiveness to conservative treatment (such as exercise, NSAID)
- •At least 3 of the five sacroiliac provocation tests (FABER (Patrick), thigh thrust, Gaenslen, sacroiliac compression, and sacroiliac distraction tests) are positive
Exclusion Criteria
- •Refusing to participate in the study
- •Pregnancy
- •History of inflammatory disease (ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, etc.)
- •Infective sacroiliitis
- •Malignancy
- •Osteoporosis
- •Mechanical lumbosacral pathologies (spondylolisthesis, scoliosis, stenosis, etc.)
- •Neurological finding in the lower extremity
- •Pain spreading below the knee
- •History of spinal surgery
- •History of allergy to drugs to be injected (local anesthetic, contrast material, steroid allergy)
Outcomes
Primary Outcomes
Numeric Rating Scale, NRS
Time Frame: Change from baseline NRS at 3 months
NRS is an 11-grade scale that evaluates the severity of pain in adults .NRS is one of the most commonly used scales in the assessment of pain severity. Possible scores ranges from 0( no pain) to 10 ( worst pain)
Secondary Outcomes
- Oswestry Disability index(Baseline, Month 1, Month 3, Month 6)
Investigators
Yasin Demir
Associate professor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study Sites (2)
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