Dataset Information

In-Clinic Versus Web-Based Multidisciplinary Exercise-Based Rehabilitation for Treatment of Low Back Pain: Prospective Clinical Trial in an Integrated Practice Unit Model.

ABSTRACT:

Background

The recent onset of the COVID-19 pandemic has highlighted the need to reduce barriers to access physical therapy and associated care through the use of web-based programs and telehealth for those seeking treatment for low back pain (LBP). Despite this need, few studies have compared the effectiveness of clinic-based versus web-based or telehealth services.

Objective

This study aims to compare the clinical outcomes of clinic-based multidisciplinary therapy in an integrated practice unit (C-IPU) model with online integrated multidisciplinary therapy (O-IPU) in individuals undergoing conservative care for LBP.

Methods

A total of 1090 participants were prospectively recruited to participate in a clinical trial registry (NCT04081896) through the SpineZone rehabilitation IPU program. All participants provided informed consent. Participants were allocated to the C-IPU (N=988) or O-IPU (N=102) groups based on their personal preferences. The C-IPU program consisted of a high-intensity machine-based core muscle resistance training program, whereas the O-IPU program consisted of therapist-directed home core strengthening exercises through a web-based platform. Changes in LBP symptom severity (Numeric Pain Rating Scale), disability (Oswestry Disability Index), goal achievement (Patient-Specific Functional Scale), and frequency of opioid use were compared between the C-IPU and O-IPU groups using multivariate linear regression modeling adjusted for age, gender, treatment number, program duration, and baseline pain and disability.

Results

Approximately 93.03% (1014/1090) of the participants completed their recommended programs, with no group differences in dropout rates (P=.78). The C-IPU group showed greater pain relief (P<.001) and reductions in disability (P=.002) than the O-IPU group, whereas the O-IPU group reported greater improvements in goal achievement (P<.001). Both programs resulted in reduced opioid use frequency, with 19.0% (188/988) and 21.5% (22/102) of participants reporting cessation of opioid use for C-IPU and O-IPU programs, respectively, leaving only 5.59% (61/1090) of participants reporting opioid use at the end of their treatment.

Conclusions

Both in-clinic and web-based multidisciplinary programs are beneficial in reducing pain, disability, and opioid use and in improving goal achievement. The differences between these self-selected groups shed light on patient characteristics, which require further investigation and could help clinicians optimize these programs.

Trial registration

ClinicalTrials.gov NCT04081896; https://clinicaltrials.gov/ct2/show/NCT04081896.

SUBMITTER: Raiszadeh K

PROVIDER: S-EPMC8074858 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundThe long-term effects of behavioural medical rehabilitation (BMR), as a type of multidisciplinary rehabilitation, in the treatment of chronic non-specific low back pain (CLBP) have been shown. However, the specific effects of behavioural exercise therapy (BET) compared to standard exercise therapy (SET) within BMR are not well understood. The aim of the study was to assess the effectiveness of BMR + BET compared to BMR + SET in individuals with CLBP in a two-armed, pre-registered, multicentre, parallel, randomised controlled trial (RCT).MethodsA total of 351 adults with CLBP in two rehabilitation centres were online randomised based on an 'urn randomisation' algorithm to either BMR + SET (n = 175) or BMR + BET (n = 176). Participants in both study groups were non-blinded and received BMR, consisting of an multidisciplinary admission, a psychosocial assessment, multidisciplinary case management, psychological treatment, health education and social counselling. The intervention group (BMR + BET) received a manualised, biopsychosocial BET within BMR. The aim of BET was to develop self-management strategies in coping with CLBP. The control group (BMR + SET) received biomedical SET within BMR with the aim to improve mainly physical fitness. Therapists in both study groups were not blinded. The BMR lasted on average 27 days, and both exercise programmes had a mean duration of 26 h. The primary outcome was functional ability at 12 months. Secondary outcomes were e.g. pain, avoidance-endurance, pain management and physical activity. The analysis was by intention-to-treat, blinded to the study group, and used a linear mixed model.ResultsThere were no between-group differences observed in function at the end of the BMR (mean difference, 0.08; 95% CI - 2.82 to 2.99; p = 0.955), at 6 months (mean difference, - 1.80; 95% CI; - 5.57 to 1.97; p = 0.349) and at 12 months (mean difference, - 1.33; 95% CI - 5.57 to 2.92; p = 0.540). Both study groups improved in the primary outcome and most secondary outcomes at 12 months with small to medium effect sizes.ConclusionBMR + BET was not more effective in improving function and other secondary outcomes in individuals with CLBP compared to BMR + SET.Trial registrationCurrent controlled trials NCT01666639 , 16/08/2012.

Project description:ObjectiveTo assess the long term effects of multidisciplinary biopsychosocial rehabilitation for patients with chronic low back pain.DesignSystematic review and random effects meta-analysis of randomised controlled trials.Data sourcesElectronic searches of Cochrane Back Review Group Trials Register, CENTRAL, Medline, Embase, PsycINFO, and CINAHL databases up to February 2014, supplemented by hand searching of reference lists and forward citation tracking of included trials.Study selection criteriaTrials published in full; participants with low back pain for more than three months; multidisciplinary rehabilitation involved a physical component and one or both of a psychological component or a social or work targeted component; multidisciplinary rehabilitation was delivered by healthcare professionals from at least two different professional backgrounds; multidisciplinary rehabilitation was compared with a non- multidisciplinary intervention.ResultsForty one trials included a total of 6858 participants with a mean duration of pain of more than one year who often had failed previous treatment. Sixteen trials provided moderate quality evidence that multidisciplinary rehabilitation decreased pain (standardised mean difference 0.21, 95% confidence interval 0.04 to 0.37; equivalent to 0.5 points in a 10 point pain scale) and disability (0.23, 0.06 to 0.40; equivalent to 1.5 points in a 24 point Roland-Morris index) compared with usual care. Nineteen trials provided low quality evidence that multidisciplinary rehabilitation decreased pain (standardised mean difference 0.51, -0.01 to 1.04) and disability (0.68, 0.16 to 1.19) compared with physical treatments, but significant statistical heterogeneity across trials was present. Eight trials provided moderate quality evidence that multidisciplinary rehabilitation improves the odds of being at work one year after intervention (odds ratio 1.87, 95% confidence interval 1.39 to 2.53) compared with physical treatments. Seven trials provided moderate quality evidence that multidisciplinary rehabilitation does not improve the odds of being at work (odds ratio 1.04, 0.73 to 1.47) compared with usual care. Two trials that compared multidisciplinary rehabilitation with surgery found little difference in outcomes and an increased risk of adverse events with surgery.ConclusionsMultidisciplinary biopsychosocial rehabilitation interventions were more effective than usual care (moderate quality evidence) and physical treatments (low quality evidence) in decreasing pain and disability in people with chronic low back pain. For work outcomes, multidisciplinary rehabilitation seems to be more effective than physical treatment but not more effective than usual care.

Project description:BackgroundIn Germany, a multidisciplinary rehabilitation named "behavioural medical rehabilitation" (BMR) is available for treatment of chronic low back pain (clbp). A central component of BMR is standard exercise therapy (SET), which is directed mainly to improve physical fitness. There is a need to address psychosocial factors within SET and therefore to improve behavior change with a focus on the development of self-management skills in dealing with clbp. Furthermore, short-term effectiveness of BMR with a SET has been proven, but the impact of a behavioural exercise therapy (BET) for improvement of the long-term effectiveness of BMR is unclear.Methods/designTo compare the effectiveness of two exercise programs with different approaches within BMR on the effects of BMR a prospective randomized controlled trial (RCT) in two rehabilitation centres will be performed. 214 patients aged 18-65 with clbp will be, based on an "urn randomisation"-algorithm, randomly assigned to a BMR with SET (function-oriented, n=107) and BMR with BET (behaviour-oriented, n=107). Both exercise programs have a mean duration of 26 hours in three weeks and are delivered by a limited number of not-blinded study therapists in closed groups with six to twelve patients who will be masked regarding study group. The main differences of BET lie in its detailed manualised program with a theory-based, goal-orientated combination of exercise, education and behavioural elements, active participation of patients and consideration of their individual preferences and previous experiences with exercise. The primary outcome is functional ability assessed with the Hannover Functional Ability Questionnaire directly before and after the rehabilitation program, as well as a six and twelve-month follow-up.DiscussionThis RCT is designed to explore the effects of BET on the effectiveness of a BMR compared to a BMR with SET in the management of patients with clbp. Methodological challenges arise from conducting a RCT within routine health care as well as from ensuring high treatment integrity. Findings of this study might contribute to a better understanding of the mechanism of action of BMR and the special effects of BET and may be used to improve the quality of these interventions in routine care, therefore reducing the burden to patients with disabling clbp.Trial registrationCurrent controlled trials NCT01666639.