ESWT for Low Back Pain

NCT07245498 | Completed

• 1 other identifier: TABED 2-24-246
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

Keywords

low back pain,; Extracorporeal shock wave therapy; Conventional physical therapy

Outcome Measures

Primary Outcomes (1)

• visual analog scale(VAS)

  The VAS is a validated tool for assessing pain intensity. It consists of a 10-cm horizontal line anchored by "no pain" (0) at the left end and "worst imaginable pain" (10) at the right end. Participants indicate their perceived pain level by marking a point on the line, which is then measured in centimeters to provide a continuous pain score from 0 to 10.

  Before treatment, Baseline and 1month after treatment

Secondary Outcomes (2)

• oswestry disability score(ODI),

  Before treatment, Baseline, 1st month after treatment

• hospital anxiety and depression scale(HADS)

  Before treatment, Baseline, 1st month after treatment

Study Arms (2)

Ekstra corporeal shock wave therapy(ESWT)

ACTIVE COMPARATOR

Ekstra corporeal shock wave therapy + conventional physical therapy +exercise

Other: extracorporeal shock wave therapy

sham Ekstra corporeal shock wave therapy

SHAM COMPARATOR

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

Other: extracorporeal shock wave therapy

Interventions

extracorporeal shock wave therapy 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

Ekstra corporeal shock wave therapy(ESWT); sham Ekstra corporeal shock wave therapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group 1: Radial ESWT+conventional physical therapy+exercise Group 2: sham ESWT+conventional physical therapy+exercise Assesments: before treatment, after treatment and 1th month after treatment primer outcome: VAS seconder outcomes: Oswestry disability index, hospital axiety and depression scale

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: November 24, 2025
• Study Start: September 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

TU (1)