Evidence map›Paper›PMID 26112148›Full record

Trial reportTrials2015

Effect of heating and cooling combination therapy on patients with chronic low back pain: study protocol for a randomized controlled trial.

Eun-Jung Kim, Young-Doo Choi, Chi-Yeon Lim, Kyung-Ho Kim, Seung-Deok Lee

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02289170 (A Randomized, Double-blind, Multicenter, Parallel Designed Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT02289170 naunknown statusnot on this map

A Randomized, Double-blind, Multicenter, Parallel Designed Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100) in Patients With Chronic Low Back Pain

TypeinterventionalSponsorEun Jung KimRan2014 to 2015Enrolled80ConditionsChronic Low Back PainArmsHeating and cooling combination therapy, Sham heating and cooling therapy
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
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

5 authors.

Eun-Jung KimCollege of Korean Medicine, Dongguk University, Gyeongju, South Korea. hanijjung@naver.com.
Young-Doo ChoiCollege of Korean Medicine, Dongguk University, Gyeongju, South Korea. ydseeker@naver.com.
Chi-Yeon LimDepartment of Medicine, Dongguk University, Gyeongju, South Korea. rachun@hanmail.net.
Kyung-Ho KimCollege of Korean Medicine, Dongguk University, Gyeongju, South Korea. omdkkh@hanmail.net.
Seung-Deok LeeCollege of Korean Medicine, Dongguk University, Gyeongju, South Korea. chuckman100@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinicians often apply heating or cooling stimulation for treatment of musculoskeletal pain. However, scalding, frostbite and skin ulcers may occur from the excessive use of either therapy alone. Heating and cooling combination therapy may be a suitable alternative for treatment of musculoskeletal diseases, although insufficient research has documented the safety and efficacy of such therapy. The purpose of this clinical trial is to determine the efficacy and safety of heating and cooling combination therapy for treatment of chronic low back pain. METHODS/

designThis is a multicenter, parallel-group, double-blinded, randomized controlled trial to evaluate the efficacy and safety of a heating and cooling combination therapeutic device (OCH-S100) in patients with chronic low back pain. Eighty participants with chronic low back pain will be recruited from two hospitals in South Korea (Dongguk University Ilsan Oriental Hospital and Dongguk University Bundang Oriental Hospital). Enrolled patients will be randomly divided into a treatment group and a sham group. Patients in both groups will be given 10 treatments (15 min per treatment) over 4 weeks. The protocol will consist of five cycles of heating/cooling therapy (maximum: 45 °C, minimum: 15 °C) in the treatment group, and five cycles of sham therapy (maximum: 1 °C above skin temperature, minimum: 1 °C below skin temperature) in the sham group. The primary outcome measure is change from baseline in the 100 mm Visual Analogue Scale (VAS) for pain after 4 weeks. There are six secondary outcome measures that consider disability or range of motion (ROM). DISCUSSION: This research will determine the efficacy and safety of heating and cooling combination therapy on chronic low back pain. The results of this trial may have important implications for the more widespread use of heating and cooling combination therapy for treatment of musculoskeletal pain.

trial registrationNCT02289170 (14 October 2014).

Indexed as

Clinical ProtocolsCryotherapyAdultAgedChronic PainDouble-Blind MethodHot TemperatureHumansLow Back PainMiddle Aged

Identifiers

PMID26112148
PMCPMC4494172

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Registered trials

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.