Evidence map›Paper›PMID 28095892›Full record

Trial reportTrials2017

Comparative effectiveness and cost-effectiveness of Chuna manual therapy versus conventional usual care for nonacute low back pain: study protocol for a pilot multicenter, pragmatic randomized controlled trial (pCRN study).

Byung-Cheul Shin, Me-Riong Kim, Jae-Heung Cho, Jae-Young Jung, Koh-Woon Kim, Jun-Hwan Lee, Kibong Nam, Min Ho Lee, Eui-Hyoung Hwang, Kwang-Ho Heo and 2 more

Open access · goldAbstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.3field-weighted citation impact, top 21% 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, 11 citations in OpenAlex.

  1. Trial
  2. Article
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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

12 authors at 5 institutions in 1 country.

Byung-Cheul ShinSpine and Joint Center, Pusan National University Korean Medicine Hospital, Yangsan, Republic of Korea.
Me-Riong KimJaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 858 Eonju-ro, Gangnam-gu, Seoul, 135-896, Republic of Korea.
Jae-Heung ChoDepartment of Korean Rehabilitation Medicine, Kyung Hee University, Seoul, Republic of Korea.
Jae-Young JungDepartment of Korean Rehabilitation Medicine, Kyung Hee University, Seoul, Republic of Korea.
Koh-Woon KimDepartment of Korean Rehabilitation Medicine, Kyung Hee University, Seoul, Republic of Korea.
Jun-Hwan LeeClinical Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
Kibong NamMokhuri Neck and Back Hospital, Seoul, Republic of Korea.
Min Ho LeeMokhuri Neck and Back Hospital, Seoul, Republic of Korea.
Eui-Hyoung HwangSpine and Joint Center, Pusan National University Korean Medicine Hospital, Yangsan, Republic of Korea.
Kwang-Ho HeoSpine and Joint Center, Pusan National University Korean Medicine Hospital, Yangsan, Republic of Korea.
Namkwen KimCenter for Comparative Effectiveness Research and Economic Evaluation in Korean Medicine, Pusan National University, Yangsan, Republic of Korea.
In-Hyuk HaJaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 858 Eonju-ro, Gangnam-gu, Seoul, 135-896, Republic of Korea. hanihata@gmail.com.ORCID 0000-0002-5020-6723
Kyung Hee University · KRPusan National University Yangsan Hospital · KRJaseng Medical Foundation · KRKorea Institute of Oriental Medicine · KRPusan National University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhile Chuna manual therapy is a Korean manual therapy widely used primarily for low back pain (LBP)-related disorders in Korea, well-designed studies on the comparative effectiveness of Chuna manual therapy are scarce. METHODS/

designThis study is the protocol for a three-armed, multicenter, pragmatic randomized controlled pilot trial. Sixty severe nonacute LBP patients (pain duration of at least 3 weeks, Numeric Rating Scale (NRS) ≥5) will be recruited at four Korean medicine hospitals. Participants will be randomly allocated to the Chuna group (n = 20), usual care group (n = 20), or Chuna plus usual care group (n = 20) for 6 weeks of treatment. Usual care will consist of orally administered conventional medicine, physical therapy, and back pain care education. The trial will be conducted with outcome assessor and statistician blinding. The primary endpoint will be NRS of LBP at week 7 post randomization. Secondary outcomes include NRS of leg pain, the Oswestry Disability Index (ODI), the Patient Global Impression of Change (PGIC), the Credibility and Expectancy Questionnaire, lumbar range of motion (ROM), the EuroQol-5 Dimension (EQ-5D) health survey, the Health Utility Index III (HUI-III), and economic evaluation and safety data. Post-treatment follow-ups will be conducted at 1, 4, and 10 weeks after conclusion of treatment. DISCUSSION: This study will assess the comparative effectiveness of Chuna manual therapy compared to conventional usual care. Costs and effectiveness (utility) data will be analyzed for exploratory cost-effectiveness analysis. If this pilot study does not reach a definite conclusion due to its small sample size, these results will be used as preliminary results to calculate sample size for future large-scale clinical trials and contribute in the assessment of feasibility of a full-scale multicenter trial.

trial registrationClinical Research Information Service (CRIS), KCT0001850 . Registered on 17 March 2016.

Indexed as

Health Care CostsAdultAgedClinical ProtocolsComparative Effectiveness ResearchCost-Benefit AnalysisDisability EvaluationFemaleHumansLow Back PainMaleMiddle AgedMusculoskeletal ManipulationsPain MeasurementPilot ProjectsRecovery of FunctionComplementary therapiesCost-benefit analysisLow back painProtocolSpinal manipulation

Identifiers

PMID28095892
PMCPMC5240424
OpenAlexW2571555148

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Registered trials

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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.