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

NCT05181579 | Completed

• 1 other identifier: 25
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Sacroiliac Joint Somatic Dysfunction

Keywords

Sacroiliac joint dysfunction; Manuel therapy; Sacroiliac joint injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Oswestry Disability index

  Baseline, Month 1, Month 3, Month 6

Study Arms (2)

Manuel therapy and exercise group

EXPERIMENTAL

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

Sacroiliac injection and exercise group

EXPERIMENTAL

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

Interventions

Manuel therapy OTHER

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.

Manuel therapy and exercise group

Sacroiliac joint injection OTHER

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.

Sacroiliac injection and exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

Location

Study Officials

• Umut Guzelkucuk, MD

  SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: January 6, 2022
• Study Start: September 29, 2021
• Primary Completion: March 15, 2022
• Study Completion: September 15, 2022
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)