Chronic Low-back PainNCT03987971
Acupuncture on GB26 to Treat Chronic Low Back Pain
A study testing acupuncture in people with Chronic Low-back Pain, run by Wenzhou Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
About this study
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
- Being tested
- acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
Acupuncture on GB26, every other day, 3 times a week, 2 weeks in total.
| Study group | Role | What they receive |
|---|---|---|
| Deep acupuncture on GB26 | Experimental | Not described Receives: Other: acupuncture |
| Superficial acupuncture on GB26 | Sham comparator | Not described Receives: Other: acupuncture |
| waiting list | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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%).
Measured: Change from baseline NRS score at 1 weeks, 2 weeks, 4 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study startJan 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Qingtian People's hospital
- Responsible party
- Principal investigator, Tang Lewei, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987971
- Sponsor's protocol ID
- GB264LBP
- Status last verified
- Jun 2019
- First submitted
- 13 Jun 2019
- Last updated
- 17 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture on GB26 to Treat Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03987971
- Acronym / sponsor ID
- GB264LBP
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Qingtian People's hospital
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Deep acupuncture on GB26 | Experimental | Other: acupuncture |
| Superficial acupuncture on GB26 | Sham comparator | Other: acupuncture |
| waiting list | No intervention | – |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureAcupuncture on GB26, every other day, 3 times a week, 2 weeks in total. | Other | Deep acupuncture on GB26, Superficial acupuncture on GB26 |
Primary outcome
Change in Numerical Rating Scale (NRS) score
Time frame: Change from baseline NRS score at 1 weeks, 2 weeks, 4 weeks and 12 weeks
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
Time frame: Change from baseline NRS score at 1 weeks, 2 weeks, 4 weeks and 12 weeks
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%).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Chronic Low-back Pain, run by Wenzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numerical Rating Scale (NRS) score (time frame: Change from baseline NRS score at 1 weeks, 2 weeks, 4 weeks and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.