Evidence map›Paper›PMID 29794761›Full record

Trial reportMedicine2018

Efficacy and safety of thread embedding acupuncture combined with conventional acupuncture for chronic low back pain: A study protocol for a randomized, controlled, assessor-blinded, multicenter clinical trial.

Jungtae Leem, Hyunho Kim, Hee-Geun Jo, Sae-Rom Jeon, Yejin Hong, Yeoncheol Park, Byungkwan Seo, Yeeun Cho, Jung Won Kang, Eun-Jung Kim and 5 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 6 institutions in 2 countries.

Jungtae LeemDongshin Korean Medicine Hospital, Seoul Chung-Yeon Medical Institute Chung-Yeon Korean Medicine Hospital, Gwangju Department of Clinical Korean Medicine Department of Acupuncture & Moxibustion, Graduate School Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Gyeonggi-do Department of Acupuncture & Moxibustion, College of Korean Medicine, Daegu Haany University, Gyeongsangbuk-do Department of Clinical Research of Korean Medicine, Kyung Hee University, Seoul, South Korea.
Hyunho Kim
Hee-Geun Jo
Sae-Rom Jeon
Yejin Hong
Yeoncheol Park
Byungkwan Seo
Yeeun Cho
Jung Won Kang
Eun-Jung Kim
Ga Young Han
Jae Soo Kim
Hyun-Jong Lee
Tae-Hun Kim
Dongwoo Nam
Kyung Hee University · KRDaegu Haany University · KRDongshin University · KRChina Association of Acupuncture-Moxibustion · CNChungwoon University · KRDongguk University · KR

Funding

HSRD VA SDR 10-012NIEHS NIH HHS 27301C0040
6 · The paper itself

Abstract

backgroundBack pain is one of the most common diseases, and many patients with recurrent pain seek alternative treatment strategies. Thread embedding acupuncture involves thread insertion at the acupuncture point for continuous physical and chemical stimulation. Although thread embedding is widely used in clinical practice, there is no sound evidence of its efficacy for chronic back pain. We describe the protocol for a randomized controlled trial for investigation of the efficacy and safety of thread embedding acupuncture combined with conventional acupuncture for chronic low back pain.

methodsThis randomized, controlled, assessor-blinded, 2-armed, parallel, multicenter clinical trial will include 38 outpatients with chronic low back pain recruited from 4 traditional Korean Medicine hospitals. The patients will be randomly allocated to a treatment group (conventional acupuncture + thread embedding acupuncture) and a control group (only conventional acupuncture) in a 1:1 ratio. The treatment group patients will receive thread embedding acupuncture treatment at 10 acupuncture points (multifidus muscle, 4 points; spinal erector muscles, four points; lumbar quadrate muscle, 2 points) once a week for 8 weeks (8 sessions). In addition, all patients will receive conventional acupuncture treatment at 14 acupuncture points (GV3, EX-B5, and bilateral BL23, BL24, BL25, BL26, BL40, and BL60) twice a week for 8 weeks (16 sessions). The primary outcome will be the change in the visual analog scale score from visit 1 to visit 16, analyzed by independent t tests, in both groups. The groups will also be compared with regard to the clinical relevance (minimal clinically important difference), quality of life (3-level version of Euroqol-5D), disability level (Roland and Morris Disability Questionnaire), global assessment (patient global impression of change), and safety. Cost data for cost-benefit and cost-effectiveness analyses will be collected. DISCUSSION: Our study results will provide evidence of the efficacy and safety of thread embedding acupuncture combined with conventional acupuncture for the management of chronic low back pain. Even though the assessors will be blinded, the patients will not be blinded to treatment because of the lack of a sham embedding acupuncture group; this is a limitation of our study.

trial registrationClinical Research Information Service: KCT0002666.

Indexed as

Acupuncture TherapyAdultAgedChronic PainCost-Benefit AnalysisDisability EvaluationFemaleHumansLow Back PainMaleMiddle AgedPain MeasurementQuality of LifeRepublic of KoreaResearch DesignTreatment Outcome

Identifiers

PMID29794761
PMCPMC6392913
OpenAlexW2804832760

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.