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

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ClinicalTrials.gov Identifier: NCT03337607
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
First Affiliated Hospital of Zhejiang University

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Device: rESWT Drug: Celecoxib Drug: Eperisone Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled, Single Centre Trial to Assess the Efficacy and Safety of Radial Extracorporeal Shock Wave Therapy in Patients With Chronic Non-specific Low Back Pain
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain Shock

Arm Intervention/treatment
Active Comparator: rESWT plus C-E drugs
Patients will receive rESWT, Celecoxib and Eperisone
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
Other Name: non-steroidal anti-inflammatory drug

Drug: Eperisone
3 x 50 mg per day for four weeks
Other Name: antispasmodic drug

Active Comparator: rESWT alone
Patients will receive rESWT
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

Active Comparator: C-E drugs alone
Patients will receive Celecoxib and Eperisone
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
Other Name: non-steroidal anti-inflammatory drug

Drug: Eperisone
3 x 50 mg per day for four weeks
Other Name: antispasmodic drug




Primary Outcome Measures :
  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) [ Time Frame: Change from baseline PSEQ score at 12 weeks ]

    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.


Secondary Outcome Measures :
  1. Change in Numerical Rating Scale (NRS) score [ Time Frame: Change from baseline NRS score at 2 weeks, 4 weeks, 12 weeks and 24 weeks ]
    The NRS will ask patients to rate their pain intensity on an 11-point scale where 0 indicates no pain and 10 indicates worst imaginable pain.

  2. Change in Oswestry Low Back Pain Disability Questionnaire (OLDPDQ) score [ Time Frame: Change from baseline OLDPDQ score at 2 weeks, 4 weeks, 12 weeks and 24 weeks ]
    The OLDPDQ score is considered the 'gold standard' of low back functional outcome tools. The questionnaire is composed of ten sections (addressing pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling); for each section the possible score is 5 and, thus, the total possible score is 50. The final score is calculated as [(sum of individual scores) / 50] *100 (%), and is interpreted as minimal disability (0% to 20%), moderate disability (21% to 40%), severe disability (41% to 60%), crippled (61% to 80%) or patients are either bed-bound or exaggerating their symptoms (81% to 100%).

  3. Change in Patient Health Questionnaire 9 (PHQ-9) score [ Time Frame: Change from baseline PHQ-9 score at 2 weeks, 4 weeks, 12 weeks and 24 weeks ]
    The PHQ-9 will be used to assess depression. Patients will be asked how often, over the last two weeks, they had been bothered by the following problems: (i) little interest or pleasure in doing things; (ii) feeling down, depressed or hopeless; (iii) trouble falling or staying asleep, or sleeping too much; (iv) feeling tired or having little energy; (v) poor appetite or overeating; (vi) feeling bad about themselves, or that they are a failure or have let themselves or their family down; (vii) trouble concentrating on things, such as reading the newspaper or watching television; (viii) moving or speaking so slowly that other people could have noticed? Or the opposite - being so fidgety or restless that they have been movin around a lot more than usual; and (ix) thoughts that they would be better of dead or of hurting themselves in some way.

  4. Change in lumbar curvature measurements performed on lateral lumbosacral spine radiographs [ Time Frame: Change from baseline at 12 weeks ]
    There is a strong relationship between non-specific low back pain and decreased lumbar lordotic curvature. Lateral X-rays of the lumbar spine will be taken in the standing position according to standard protocols in the literature, and analyzed using Cobb's angle, vertebral body and intervertebral disc wedging, and facet joint angle.

  5. Change in Pain Self-Efficacy Questionnaire (PSEQ) score (Nicholas, 1989) [ Time Frame: Change from baseline PSEQ score at 2 weeks, 4 weeks and 24 weeks ]

    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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]).
  • Participation in any other clinical trial in the time period of 12 weeks before potential inclusion in the proposed study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337607


Contacts
Contact: Zyiying Feng, MD +86-13989881666 13989881666@163.com

Locations
China, Zhejiang
Department of Pain Medicine, First Affiliated Hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Zyiying Feng, MD    +86-13989881666    13989881666@163.com   
Sponsors and Collaborators
First Affiliated Hospital of Zhejiang University
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Zyiying Feng, MD Department of Pain Medicine, First Affiliated Hospital of Zhejiang University, Hangzhou, China
  Study Documents (Full-Text)

Documents provided by First Affiliated Hospital of Zhejiang University:

Responsible Party: First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier: NCT03337607     History of Changes
Other Study ID Numbers: FengDolorClastLowBackPain
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data (IPD) will not be shared with other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by First Affiliated Hospital of Zhejiang University:
Extracorporeal shock wave therapy
ESWT
Radial extracorporeal shock wave therapy
rESWT
Chronic non-specific low back pain
Non-steroidal anti-inflammatory drug

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Celecoxib
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Eperisone
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Muscle Relaxants, Central
Neuromuscular Agents
Parasympatholytics
Autonomic Agents
Vasodilator Agents