| 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 | |||||
|---|---|---|---|---|---|
| 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 |
|
||||
| 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 |
||||
| 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 |
|
||||
| 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 |
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