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)

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.DiscussionThis 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1756-8) contains supplementary material, which is available to authorized users.

Comparative Effectiveness of Chuna Manipulative Therapy for Non-Acute Lower Back Pain: A Multi-Center, Pragmatic, Randomized Controlled Trial

“…Cases receiving injections such as steroid nerve blocks were monitored and regarded as dropouts. Details on the Chuna techniques and UC used in the previous trial and detailed instruction materials utilized in this subsequent full-scale study can be found in the pilot protocol [13], and pilot trial [11].…”

“…CMT focuses on meridian theory and meridian muscle concepts, and CMT clinicians also focus the breathing of patients during the treatment procedure. CMT adopted a semi-standardized treatment plan established by selecting Chuna technique based on CMT expert opinions on LBP collected via surveys of Chuna clinical experts (total n = 20) [13]. A survey for standardization was conducted to find the validity of the duration of treatment session and adequate technique.…”

“…The physicians administering CMT in this trial were Korean medical doctors with more than three years of clinical experience using CMT, and received CMT protocol training sessions (two sessions, 4 h/session) for standardized applications. The CMT techniques utilized in this study were divided into lumbar and pelvic regions, and mandatory or selective techniques were performed following physician judgement [13]. CMT sessions were administered over a period of 6 weeks.…”

“…The time duration of one CMT session consisted of approximately 5 min of diagnosis and 10 min of treatment. The modalities we utilized were shown in a previous pilot protocol, and this gave additional information [13].…”

Can a Traditional Korean Manual Therapy Be a Complementary and Alternative Strategy for Cervicogenic Dizziness? A Study Protocol for a Randomized Controlled Trial

“…It is a therapeutic technique for modulating both orthopedic and functional balances simultaneously [ 15 ]. CMT usually involves high-velocity and low-amplitude thrusts to the joints and applies manual force to joints in the passive range of motion [ 16 ]. It is widely used in clinical practice for patients with musculoskeletal pain, such as low back pain, neck pain, or temporomandibular joint disorders [ 15 ].…”