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

Sacroiliac Joint Somatic Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05181579
• Other study ID #: 25
• Status: Completed
• Phase: N/A
• Start date: September 29, 2021
• Est. completion date: September 15, 2022

Study information

• Verified date: July 2023
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Joint Diseases
• Sacroiliac Joint Somatic Dysfunction

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital	Ankara	Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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