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

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

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

Study Overview

• Status: Completed
• Conditions: Sacroiliac Joint Somatic Dysfunction
• Intervention / Treatment: Other: Sacroiliac joint injection; Other: Manuel therapy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Cankaya
    • Ankara, Cankaya, Turkey, 06800
      • SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sacroiliac injection and exercise group; 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; 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.
Experimental: Manuel therapy and exercise group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Investigators: Study Director: Umut Guzelkucuk, MD, SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Sacroiliac joint dysfunction; Manuel therapy; Sacroiliac joint injection
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No