ESWT for Low Back Pain

NCT ID: NCT07245498

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-08-01

Brief Summary

The goal of this interventional study is to compare the effects of ESWT in women and men between the age 18-65 with non radicular non specific low back pain . The main question it aims to answer is:

Is intervention ESWT more effective than conventional physical therapy agents. Patients were divided into 2 groups; Group 1 ESWT+conventional physical therapy and group 2: sham ESWT+conventional physical therapy. Study follow up time before treatment, 0 week after treatment, and 1 month after treatment.

Conditions

Low Back Pain; Physical Therapy; Extracorporeal Shock Wave Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ekstra corporeal shock wave therapy(ESWT)

Ekstra corporeal shock wave therapy + conventional physical therapy +exercise

Group Type: ACTIVE_COMPARATOR

extracorporeal shock wave therapy

Intervention Type: OTHER

Shock wave probe applied perpendicularly to the quadratus lumborum, the sacroiliac joint, and the regions of the patient's lumbar area where pain is localized, following the application of coupling gel to facilitate the transmission of pressure waves generated by the device through the skin via its metallic applicator head

sham Ekstra corporeal shock wave therapy

sham Ekstra corporeal shock wave therapy+ conventional physical therapy +exercise

Group Type: SHAM_COMPARATOR

extracorporeal shock wave therapy

Intervention Type: OTHER

Shock wave probe applied perpendicularly to the quadratus lumborum, the sacroiliac joint, and the regions of the patient's lumbar area where pain is localized, following the application of coupling gel to facilitate the transmission of pressure waves generated by the device through the skin via its metallic applicator head

Interventions

extracorporeal shock wave therapy

Shock wave probe applied perpendicularly to the quadratus lumborum, the sacroiliac joint, and the regions of the patient's lumbar area where pain is localized, following the application of coupling gel to facilitate the transmission of pressure waves generated by the device through the skin via its metallic applicator head

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male and female patients between the ages of 18 and 65 who have had low back pain for at least three months and have been diagnosed with chronic low back pain.
• Patients who consent to participate in the study according to the informed consent form will be included in the study.

Exclusion Criteria

• Diagnosis of spondylolisthesis, spondylolysis, spinal tumors, intervertebral disc infections, severe osteoporosis, or lumbar vertebral fractures and patients with a history of prior spine surgery,
• Currently using anti-inflammatory drugs or analgesics in last four weeks,
• Local skin infection or damage at the treatment site,
• Inflammatory rheumatic diseases,
• Pregnancy
• Concomitant mental diseases.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ankara City Hospital

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TABED 2-24-246

Identifier Type: -

Identifier Source: org_study_id