Efficacy of Manual Therapy and Sacroiliac Joint Injection in Sacroiliac Joint Dysfunction

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of manual therapy and sacroiliac joint injections in patients with sacroiliac joint dysfunction

Official Title
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Efficacy of Manual Therapy and Sacroiliac Joint Injection in the Treatment of Patients With Sacroiliac Joint Dysfunction

Conditions
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Sacroiliac Joint Somatic Dysfunction

Intervention / Treatment
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* Other: Manuel therapy
* Other: Sacroiliac joint injection


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manuel therapy and exercise group<br>Patients in the manual therapy group will receive 5 sessions of sacroiliac joint manipulation once a week. And home exercises will be given and told. Each patient will do exercise 4 days a week for 4 weeks. | Other: Manuel therapy<br>* Some sacroiliac manipulation and mobilization techniques will be applied to patients by an experienced physiatrist. Patients in the manual therapy group will receive 5 sessions of sacroiliac joint manipulation once a week.<br>|
| Experimental: Sacroiliac injection and exercise group<br>To patients in the injection group corticosteroid (1 ml 40 mg methylprednisolone) and local anesthetic (1 ml 1% lidocaine)will be injected into the sacroiliac joint using a 22 G spinal needle, guided by fluoroscopy (C-arm fluoroscopy). And home exercises will be given and told. Each patient will do exercise 4 days a week for 4 weeks. | Other: Sacroiliac joint injection<br>* Corticosteroid (1 ml 40 mg methylprednisolone) and local anesthetic (1 ml 1% lidocaine) will be injected into the sacroiliac joint using a 22 G spinal needle, guided by fluoroscopy (C-arm fluoroscopy) by an experienced physiatrist. It will be applied just one time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale, NRS | 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) | Change from baseline NRS at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability index | The Oswestry disability index will be used to evaluate how much the patients' low back pain limits their activities in daily life. This index was first created in 1980 . The questionnaire consists of 10 sections, each assessing limitations in different daily activities and functions. Each section is scored from 0 to 5. A score of 0 indicates that there is no restriction while doing that activity, while a score of 5 represents the highest level of restriction in that activity. The maximum score is 50. As the total score increases, the disability level of the individual increases. In 2004, Turkish validity study was carried out by Yakut et al. | Baseline, Month 1, Month 3, Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sacroiliac joint dysfunction, Manuel therapy, Sacroiliac joint injection