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Completed

NCT Number: NCT07245498

ESWT for 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. visual analog scale(VAS)

    Time frame: Before treatment, Baseline and 1month after treatment

    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.

Secondary outcomes

  1. oswestry disability score(ODI),

    Time frame: Before treatment, Baseline, 1st month after treatment

    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.

  2. hospital anxiety and depression scale(HADS)

    Time frame: Before treatment, Baseline, 1st month after treatment

    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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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