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

Not Applicable

Completed

• Conditions: Sacroiliac Joint Somatic Dysfunction
• Interventions: Other: Manuel therapy; Other: Sacroiliac joint injection

• Registration Number: NCT05181579
• Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-29
• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2021-12-20
• Study First Posted: 2022-01-06
• Primary Completion: 2022-03-15
• Study Completion: 2022-09-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manuel therapy and exercise group	Manuel therapy	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.
Sacroiliac injection and exercise group	Sacroiliac joint injection	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.

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale, NRS	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 Outcome Measures

Name	Time	Method
Oswestry Disability index	Baseline, Month 1, Month 3, Month 6	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.

Trial Locations

Locations (1)

SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital; 🇹🇷 Ankara, Cankaya, Turkey