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Radial Extracorporeal Shock Wave Therapy for Chronic Non-specific Low Back Pain

NCT03337607 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-01-08

No results posted yet for this study

Summary

This study tests the hypothesis that radial extracorporeal shock wave therapy (rESWT) in combination with the non-steroidal anti-inflammatory drug Celecoxib and the antispasmodic drug Eperisone (hereafter, "C-E drug therapy") is statistically significantly more effective than either rESWT or C-E drug therapy alone in the treatment of chronic non-specific low back pain.

Conditions

  • Low Back Pain

Interventions

DEVICE

rESWT

rESWT will be performed as follows: * Four rESWT sessions * One rESWT session per week * 4 × 1000 radial extracorporeal shock waves (rESWs) per session (1000 rESWs each applied to the left and the right paravertebral muscles above L3 to S1 using the 36-mm applicator, plus 1000 rESWs each applied to the left and the right sacroiliac joint using the 15-mm convex applicator, in prone position of the patient. * rESWs applied at 15 Hz * Air pressure of the rESWT device gradually increased during the first 200 rESWs each until the maximum discomfort the patient can tolerate will be reached, followed by 800 rESWs at this air pressure / energy flux density. * No application of local anaesthetics

DRUG

Celecoxib

1 x 200 mg per day for moderate pain (Numerical Rating Scale score 4-6 on an 11-point scale where 0 indicates no pain and 10 indicates worst imaginable pain), or 2 x 200 mg per day (Numerical Rating Scale 7-10), respectively, for four weeks

DRUG

Eperisone

3 x 50 mg per day for four weeks

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Zyiying Feng, MD · Department of Pain Medicine, First Affiliated Hospital of Zhejiang University, Hangzhou, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-13
Primary Completion
2019-04-05
Completion
2019-08-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03337607 on ClinicalTrials.gov