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Acupuncture on GB26 to Treat Chronic Low Back Pain

W

Wenzhou Medical University

Status

Unknown

Conditions

Chronic Low-back Pain

Treatments

Other: acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT03987971
GB264LBP

Details and patient eligibility

About

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.

Enrollment

114 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

114 participants in 3 patient groups

Deep acupuncture on GB26
Experimental group
Treatment:
Other: acupuncture
Superficial acupuncture on GB26
Sham Comparator group
Treatment:
Other: acupuncture
waiting list
No Intervention group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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