ESWT for Low Back Pain

Efficacy of Extracorporeal Shock Wave Therapy in Chronic Non-radicular Low Back Pain

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Physical Therapy; Extracorporeal Shock Wave Therapy
• Intervention / Treatment: Other: extracorporeal shock wave therapy

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Çankaya
    • Ankara, Çankaya, Turkey (Türkiye), 06800
      • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ekstra corporeal shock wave therapy(ESWT); Ekstra corporeal shock wave therapy + conventional physical therapy +exercise	Other: 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
Sham Comparator: sham Ekstra corporeal shock wave therapy; sham Ekstra corporeal shock wave therapy+ conventional physical therapy +exercise	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
oswestry disability score(ODI),	The ODI is a widely used, validated questionnaire designed to measure disability related to low back pain. It consists of 10 sections covering domains such as pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment/homemaking. Each section is scored from 0 to 5, with higher scores indicating greater disability. The total score is expressed as a percentage, with 0% representing no disability and 100% representing maximum disability.	Before treatment, Baseline, 1st month after treatment
hospital anxiety and depression scale(HADS)	The HADS is a self-administered questionnaire developed to detect states of anxiety and depression in patients with physical health problems. It consists of 14 items, divided into two subscales: anxiety (HADS-A, 7 items) and depression (HADS-D, 7 items). Each item is scored on a 4-point scale (0-3), giving a maximum score of 21 for each subscale. Higher scores indicate greater levels of anxiety or depression, with established cutoffs used to classify symptom severity.	Before treatment, Baseline, 1st month after treatment

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: October 1, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Conventional physical therapy; Extracorporeal shock wave therapy; low back pain,
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain; Therapeutics; Physical Therapy Modalities; Rehabilitation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Extracorporeal Shockwave Therapy
• Other Study ID Numbers: TABED 2-24-246

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No