Acupuncture on GB26 to Treat Chronic Low Back Pain

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Other: acupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 114
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Numerical Rating Scale (NRS) score	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	Change from baseline NRS score at 1 weeks, 2 weeks, 4 weeks and 12 weeks
Change in Oswestry Low Back Pain Disability Questionnaire (OLDPDQ) score	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%).	Change from baseline NRS score at 1 weeks, 2 weeks, 4 weeks and 12 weeks

Collaborators and Investigators

• Sponsor: Wenzhou Medical University
• Collaborators: Qingtian People's hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: June 13, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: GB264LBP

Drug and device information, study documents

• 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