Acupuncture on GB26 to Treat Chronic Low Back Pain

NCT ID: NCT03987971

Last Updated: 2019-06-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2021-07-31

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.

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Deep acupuncture on GB26

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

Acupuncture on GB26, every other day, 3 times a week, 2 weeks in total.

Superficial acupuncture on GB26

Group Type: SHAM_COMPARATOR

acupuncture

Intervention Type: OTHER

Acupuncture on GB26, every other day, 3 times a week, 2 weeks in total.

waiting list

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

acupuncture

Acupuncture on GB26, every other day, 3 times a week, 2 weeks in total.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qingtian People's hospital

UNKNOWN

Sponsor Role: collaborator

Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Tang Lewei

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

GB264LBP

Identifier Type: -

Identifier Source: org_study_id