Extracorporeal Shock Wave Therapy, Low Back Pain, Physical Therapy
Conditions
Keywords
low back pain,, Extracorporeal shock wave therapy, Conventional physical therapy
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.
Interventions
OTHERextracorporeal 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
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual analog scale(VAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| oswestry disability score(ODI), | 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. |
| hospital anxiety and depression scale(HADS) | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed