Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Low-back Pain | Other: acupuncture | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 114 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Acupuncture on GB26 to Treat Chronic Low Back Pain |
Estimated Study Start Date : | January 2020 |
Estimated Primary Completion Date : | January 2021 |
Estimated Study Completion Date : | July 2021 |
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 |
Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
No Contacts or Locations Provided
Tracking Information | |||||
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First Submitted Date ICMJE | June 13, 2019 | ||||
First Posted Date ICMJE | June 17, 2019 | ||||
Last Update Posted Date | June 17, 2019 | ||||
Estimated Study Start Date ICMJE | January 2020 | ||||
Estimated Primary Completion Date | January 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Acupuncture on GB26 to Treat Chronic Low Back Pain | ||||
Official Title ICMJE | Acupuncture on GB26 to Treat Chronic Low Back Pain | ||||
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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Low-back Pain | ||||
Intervention ICMJE | Other: acupuncture
Acupuncture on GB26, every other day, 3 times a week, 2 weeks in total.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
114 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 2021 | ||||
Estimated Primary Completion Date | January 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
|
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Ages ICMJE | 20 Years to 60 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | |||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03987971 | ||||
Other Study ID Numbers ICMJE | GB264LBP | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Tang Lewei, Wenzhou Medical University | ||||
Study Sponsor ICMJE | Wenzhou Medical University | ||||
Collaborators ICMJE | Qingtian People's hospital | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Wenzhou Medical University | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |