ESWT for Low Back Pain

Ankara City Hospital Bilkent69 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Low Back Pain Physical Therapy Extracorporeal Shock Wave Therapy

Interventions

extracorporeal shock wave therapyOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ankara City Hospital

Ankara, Çankaya, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: 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.

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

Data from ClinicalTrials.gov

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