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

NCT03337607 | Completed

• 1 other identifier: FengDolorClastLowBackPain
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Extracorporeal shock wave therapy; ESWT; Radial extracorporeal shock wave therapy; rESWT; Chronic non-specific low back pain; Non-steroidal anti-inflammatory drug

Outcome Measures

Primary Outcomes (1)

• Change in Pain Self-Efficacy Questionnaire (PSEQ) score (Nicholas, 1989; paper presented at the annual conference of the British Psychological Society, St. Andrews, 1989)

  Patients will be asked to rate how confident they are at the time of examination despite the presence of their pain in performing the following activities: * I can enjoy things, despite the pain. * I can do most of the household chores (e.g. tidying-up, washing dishes, etc.), despite the pain. * I can socialize with my friends or family members as often as I used to do, despite the pain. * I can cope with my pain in most situations. * I can do some form of work, despite the pain. * I can still do many of the things I enjoy doing, such as hobbies or leisure activities, despite the pain. * I can cope with my pain without additional medication (next to rESWT plus C-E drugs, rESWT alone or C-E drugs alone, respectively). * I can still accomplish most of my goals in life, despite the pain. * I can live a normal lifestyle, despite the pain. * I can gradually become more active, despite the pain.

  Change from baseline PSEQ score at 12 weeks

Secondary Outcomes (5)

• Change in Numerical Rating Scale (NRS) score

  Change from baseline NRS score at 2 weeks, 4 weeks, 12 weeks and 24 weeks

• Change in Oswestry Low Back Pain Disability Questionnaire (OLDPDQ) score

  Change from baseline OLDPDQ score at 2 weeks, 4 weeks, 12 weeks and 24 weeks

• Change in Patient Health Questionnaire 9 (PHQ-9) score

  Change from baseline PHQ-9 score at 2 weeks, 4 weeks, 12 weeks and 24 weeks

• Change in lumbar curvature measurements performed on lateral lumbosacral spine radiographs

  Change from baseline at 12 weeks

• Change in Pain Self-Efficacy Questionnaire (PSEQ) score (Nicholas, 1989)

  Change from baseline PSEQ score at 2 weeks, 4 weeks and 24 weeks

Study Arms (3)

rESWT plus C-E drugs

ACTIVE COMPARATOR

Patients will receive rESWT, Celecoxib and Eperisone

Device: rESWT; Drug: Celecoxib; Drug: Eperisone

rESWT alone

ACTIVE COMPARATOR

Patients will receive rESWT

Device: rESWT

C-E drugs alone

ACTIVE COMPARATOR

Patients will receive Celecoxib and Eperisone

Drug: Celecoxib; Drug: Eperisone

Interventions

rESWT DEVICE

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

rESWT alone; rESWT plus C-E drugs

Celecoxib DRUG

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

Also known as: non-steroidal anti-inflammatory drug

C-E drugs alone; rESWT plus C-E drugs

Eperisone DRUG

3 x 50 mg per day for four weeks

Also known as: antispasmodic drug

C-E drugs alone; rESWT plus C-E drugs

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (both male and female) with non-specific low back pain for more than three months.
• Age range: between 18 and 80 years.
• Willingness of the patient to participate in the study, and written informed consent signed and personally dated by the patient.
• Chronic non-specific low back pain clinically diagnosed as repeated lumbar sourness and swelling pain or a chronic progressive process, accompanied by (i) X-ray examination to exclude lumbar vertebrate fractures, spondylolysis, spondylolisthesis and severe osteoporosis, and/or (ii) MRI with normal signal or low nucleus pulposus signal.
• No contraindications for rESWT.

You may not qualify if:

• Children and teenagers below the age of 18.
• Elderly aged \>80 years old
• No willingness of the patient to participate in the study, and/or written informed consent not signed and not personally dated by the patient.
• Previous spinal fracture or spinal surgery.
• Protrusion of a lumbar intervertebral disk, ankylosing spondylitis, scoliosis, lumbar spondylolisthesis and lumbar spondylolysis.
• Systemic disorders and psychiatric disorders.
• Contraindications of C-E drug treatment (treatment of patients allergy to celecoxib, eperisone or sulfonamides, patients with gastrointestinal bleeding or bleeding history, patients with renal dysfunction, patients with severe heart failure, and lactating women).
• Contraindications of rESWT ( pregnant patients, patients with blood-clotting disorders \[including local thrombosis\], patients treated with oral anticoagulants, patients with local tumors, patients with local bacterial and/or viral infections \[including lumbar vertebral tuberculosis\], and patients treated with local corticosteroid applications in the time period of six weeks before the first rESWT session \[if applicable\]).

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (1)

Department of Pain Medicine, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (1)

• Guo X, Li L, Yan Z, Li Y, Peng Z, Yang Y, Zhang Y, Schmitz C, Feng Z. Efficacy and safety of treating chronic nonspecific low back pain with radial extracorporeal shock wave therapy (rESWT), rESWT combined with celecoxib and eperisone (C + E) or C + E alone: a prospective, randomized trial. J Orthop Surg Res. 2021 Dec 4;16(1):705. doi: 10.1186/s13018-021-02848-x.

  PMID: 34863239 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Celecoxib; Anti-Inflammatory Agents, Non-Steroidal; eperisone; Parasympatholytics

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Autonomic Agents

Study Officials

• Zyiying Feng, MD

  Department of Pain Medicine, First Affiliated Hospital of Zhejiang University, Hangzhou, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A medical assistant at the Department of Pain Medicine at the First Affiliated Hospital of Zhejiang University will allocate interventions by means of opaque sealed envelopes that will be marked according to the allocation schedule. The medical assistant will be unaware of the size of the blocks. The randomized intervention assignment as outlined above will be concealed from both patients and health care staff until recruitment will be complete and irrevocable. Neither patients nor therapists will be blinded in the proposed study. The therapist will be the person who will administer rEWST to the patient. The assessor will be blinded in the proposed study. The assessor is the person who will assess treatment success during follow up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 9, 2017
• Study Start: November 13, 2017
• Primary Completion: April 5, 2019
• Study Completion: August 1, 2019
• Last Updated: January 8, 2025

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)