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Acupuncture on GB26 to Treat Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT03987971
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Collaborator:
Qingtian People's hospital
Information provided by (Responsible Party):
Tang Lewei, Wenzhou Medical University

Brief Summary:
This study evaluates the effecacy of acupoint GB26 based acupuncture treatment in patients with chronic low back pain. Half of the participants will partake in a 2-week acupuncture intervention, while the other half will receive a placebo treatment. The investigators hypothesize that acupuncture on GB26 reduces disability and pain more than the control intervention.

Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Other: acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture on GB26 to Treat Chronic Low Back Pain
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Deep acupuncture on GB26 Other: acupuncture
Acupuncture on GB26, every other day, 3 times a week, 2 weeks in total.

Sham Comparator: Superficial acupuncture on GB26 Other: acupuncture
Acupuncture on GB26, every other day, 3 times a week, 2 weeks in total.

No Intervention: waiting list



Primary Outcome Measures :
  1. Change in Numerical Rating Scale (NRS) score [ Time Frame: Change from baseline NRS score at 1 weeks, 2 weeks, 4 weeks and 12 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 NRS score at 1 weeks, 2 weeks, 4 weeks and 12 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%).



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (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 20 and 60 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.

Exclusion Criteria:

  • Age less than 20 or greater than 60 years
  • Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections)
  • Complicated back problems (e.g., prior back surgery, medico-legal issues)
  • Possible contraindications for acupuncture (e.g., coagulation disorders, cardiac pacemakers, pregnancy, seizure disorder), and conditions that might confound treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis)
  • Conditions making treatment difficult (e.g., paralysis, psychoses, or other severe psychiatric problems based on the judgment of a physician investigator and/or a T score >60 on the psychological assessments performed during Session 1)
  • Prior acupuncture treatment for back pain; 1 year minimum for any other condition.
  • The intent to undergo surgery during the time of involvement in the study.
  • History of cardiac, respiratory, or nervous system disease that, in the judgment of a physician investigator, precludes participation in the study because of a heightened potential for adverse outcome (e.g., asthma, claustrophobia)
  • Presence of any contraindications to MRI scanning (e.g., cardiac pacemaker, metal implants, fear of closed spaces, pregnancy)
  • Active substance abuse disorders within the last 24 months, based on subject self-report
  • Radicular knee pain extending below the knee

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Responsible Party: Tang Lewei, Principal Investigator, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT03987971     History of Changes
Other Study ID Numbers: GB264LBP
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms