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A multi-center, randomized controlled clinical trial, cost-effectiveness and qualitative research of electroacupuncture with usual care for patients with non-acute pain after back surgery: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Although pain after back surgery is known to be difficult to control, various treatment options are available to patients and physicians. A protocol for a confirmatory randomized controlled trial (RCT) on pain and function after back surgery was designed based on the results of a pilot trial. The aim of this study is to compare the effectiveness and safety of electroacupuncture (EA) with usual care (UC) versus UC alone on pain control and functional improvement after back surgery. METHODS/DESIGN:This study is a multi-center, randomized, assessor-blinded trial with an active control conducted in conjunction with a cost-effectiveness analysis and qualitative research. Participants with non-acute low back pain with or without leg pain after back surgery who have a Visual Analogue Scale (VAS) pain intensity score???50 mm will be randomly assigned to either the EA with UC group (n?=?54) or the UC group (n?=?54). Following randomization, participants in both groups will receive the same UC treatment twice a week for a four-week treatment period. Participants assigned to the EA with UC group will additionally receive EA twice a week for the same four-week period. The primary outcome measure will be assessed using a VAS pain intensity score for low back pain. The secondary outcomes will include the Oswestry Disability Index, EuroQol 5-Dimension score, and drug intake. The primary and secondary outcomes will be measured at one, four, and eight weeks post randomization. DISCUSSION:The results of this study will provide evidence of the effectiveness and cost-effectiveness of EA in managing postoperative pain following back surgery. In addition, the qualitative research results will help improve the quality of integrative medical interventions. TRIAL REGISTRATION:Clinical Research Information Service (CRIS), Republic of Korea, KCT0001939 . Registered on 8 June 2016.

SUBMITTER: Shin BC

PROVIDER: S-EPMC5784658 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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A multi-center, randomized controlled clinical trial, cost-effectiveness and qualitative research of electroacupuncture with usual care for patients with non-acute pain after back surgery: study protocol for a randomized controlled trial.

Shin Byung-Cheul BC Cho Jae-Heung JH Ha In-Hyuk IH Heo In I Lee Jun-Hwan JH Kim Koh-Woon KW Kim Me-Riong MR Jung So-Young SY Kwon Ojin O Kim Nam-Kwen NK Son Haeng-Mi HM Son Dong-Wuk DW Shin Kyung-Min KM

Trials 20180124 1

<h4>Background</h4>Although pain after back surgery is known to be difficult to control, various treatment options are available to patients and physicians. A protocol for a confirmatory randomized controlled trial (RCT) on pain and function after back surgery was designed based on the results of a pilot trial. The aim of this study is to compare the effectiveness and safety of electroacupuncture (EA) with usual care (UC) versus UC alone on pain control and functional improvement after back surg ...[more]

PMID: 29368636

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Project description:BackgroundAcupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain.MethodsA total of 638 adults with chronic mechanical low back pain were randomized to individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland-Morris Disability Questionnaire score; range, 0-23) and symptom bothersomeness (0-10 scale). Outcomes were assessed at baseline and after 8, 26, and 52 weeks.ResultsAt 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P < .001). Participants receiving real or simulated acupuncture were more likely than those receiving usual care to experience clinically meaningful improvements on the dysfunction scale (60% vs 39%; P < .001). Symptoms improved by 1.6 to 1.9 points in the treatment groups compared with 0.7 points in the usual care group (P < .001). After 1 year, participants in the treatment groups were more likely than those receiving usual care to experience clinically meaningful improvements in dysfunction (59% to 65% vs 50%, respectively; P = .02) but not in symptoms (P > .05).ConclusionsAlthough acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture's purported mechanisms of action. It remains unclear whether acupuncture or our simulated method of acupuncture provide physiologically important stimulation or represent placebo or nonspecific effects.

Project description:BackgroundTelerehabilitation can facilitate multidisciplinary management for people with nonspecific chronic low back pain (NCLBP). It provides health care access to individuals who are physically and economically disadvantaged.ObjectiveThis study aimed to evaluate the clinical and cost-effectiveness of telerehabilitation compared with a clinic-based intervention for people with NCLBP in Nigeria.MethodsA cost-utility analysis alongside a randomized controlled trial from a health care perspective was conducted. Patients with NCLBP were assigned to either telerehabilitation-based McKenzie therapy (TBMT) or clinic-based McKenzie therapy (CBMT). Interventions were carried out 3 times weekly for a period of 8 weeks. Patients' level of disability was measured using the Oswestry Disability Index (ODI) at baseline, week 4, and week 8. To estimate the health-related quality of life of the patients, the ODI was mapped to the short-form six dimensions instrument to generate quality-adjusted life years (QALYs). Health care resource use and costs were assessed based on the McKenzie extension protocol in Nigeria in 2019. Descriptive and inferential data analyses were also performed to assess the clinical effectiveness of the interventions. Bootstrapping was conducted to generate the point estimate of the incremental cost-effectiveness ratio (ICER).ResultsA total of 47 patients (TBMT, n=21 and CBMT, n=26), with a mean age of 47 (SD 11.6) years for telerehabilitation and 50 (SD 10.7) years for the clinic-based intervention, participated in this study. The mean cost estimates of TBMT and CBMT interventions per person were 22,200 naira (US $61.7) and 38,200 naira (US $106), respectively. QALY gained was 0.085 for TBMT and 0.084 for CBMT. The TBMT arm was associated with an additional 0.001 QALY (95% CI 0.001 to 0.002) per participant compared with the CBMT arm. Thus, the ICER showed that the TBMT arm was less costly and more effective than the CBMT arm.ConclusionsThe findings of the study suggested that telerehabilitation for people with NCLBP was cost saving. Given the small number of participants in this study, further examination of effects and costs of the interventions is needed within a larger sample size. In addition, future studies are required to assess the cost-effectiveness of this intervention in the long term from the patient and societal perspective.

Project description:Low back pain is among the leading causes of medical visits and lost duty days among members of the United States Armed Forces and represents the highest 5-year risk of permanent disability in the US Army. For certain elements of care, the timing may be just as important as the type of care. The purpose of this study is to assess the impact of the timing of access to a physical therapist by patients with low back pain, by looking at outcomes and low back pain-related healthcare utilization over a 1-year period.This trial will be a two-arm pragmatic randomized clinical trial occurring at two different clinical sites in the Military Health System. We will assess outcomes and related downstream costs for patients who access physical therapy at the primary care level compared to those that receive usual care only. There will be 220 consecutive patients randomized to receive care in either group (early physical therapy or usual care only) for the first 4 weeks, and these patients will then be allowed to receive any additional care dictated by their primary care provider for the following year. The primary outcome measure is the Oswestry Disability Index. Secondary outcome measures are the Global Rating of Change, Patient Satisfaction and 1-year healthcare utilization. Follow-ups will occur at 4 weeks, 3 months and 1 year.This trial takes a pragmatic approach to delivering care by enabling a usual care environment for managing low back pain, while also allowing immediate access to physical therapy. After the initial intervention, the patient's primary provider can continue to manage the patient as he/she normally would in practice. The Military Health System Data Repository will capture all low back pain-related healthcare utilization that occurs in order to allow for a comparison between groups. Analysis from retrospective cohorts has shown improved outcomes and decreased costs for patients that received early versus late physical therapy, but this has yet to be shown in prospective trials.ClinicalTrials.Gov NCT01556581 initially on 14 March 2012.

Dataset Information

A multi-center, randomized controlled clinical trial, cost-effectiveness and qualitative research of electroacupuncture with usual care for patients with non-acute pain after back surgery: study protocol for a randomized controlled trial.

Publications

A multi-center, randomized controlled clinical trial, cost-effectiveness and qualitative research of electroacupuncture with usual care for patients with non-acute pain after back surgery: study protocol for a randomized controlled trial.

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