Clinical trial NCT03987971: Acupuncture on GB26 to Treat Chronic Low Back Pain
Official title: Acupuncture on GB26 to Treat Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: Qingtian People's hospital
First posted: 2019-06-17
Enrollment: 114
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Numerical Rating Scale (NRS) score
timeFrame: Change from baseline NRS score at 1 weeks, 2 weeks, 4 weeks and 12 weeks
measure: Change in Oswestry Low Back Pain Disability Questionnaire (OLDPDQ) score
timeFrame: Change from baseline NRS score at 1 weeks, 2 weeks, 4 weeks and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: