Back to resultsAcupuncture on GB26 to Treat Chronic Low Back Pain
Primary Purpose
Chronic Low-back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low-back Pain
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
No Intervention
Arm Label
Deep acupuncture on GB26
Superficial acupuncture on GB26
waiting list
Arm Description
Outcomes
Primary Outcome Measures
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 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%).
Secondary Outcome Measures
Full Information
NCT ID
NCT03987971
First Posted
June 13, 2019
Last Updated
June 13, 2019
Sponsor
Wenzhou Medical University
Collaborators
Qingtian People's hospital
1. Study Identification
Unique Protocol Identification Number
NCT03987971
Brief Title
Acupuncture on GB26 to Treat Chronic Low Back Pain
Official Title
Acupuncture on GB26 to Treat Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University
Collaborators
Qingtian People's hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Deep acupuncture on GB26
Arm Type
Experimental
Arm Title
Superficial acupuncture on GB26
Arm Type
Sham Comparator
Arm Title
waiting list
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
Acupuncture on GB26, every other day, 3 times a week, 2 weeks in total.
Primary Outcome Measure Information:
Title
Change in Numerical Rating Scale (NRS) score
Description
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
Time Frame
Change from baseline NRS score at 1 weeks, 2 weeks, 4 weeks and 12 weeks
Title
Change in Oswestry Low Back Pain Disability Questionnaire (OLDPDQ) score
Description
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%).
Time Frame
Change from baseline NRS score at 1 weeks, 2 weeks, 4 weeks and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Acupuncture on GB26 to Treat Chronic Low Back Pain
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