Dataset Information

A Rehabilitation Program for Individuals With Chronic Low Back Pain: Protocol for a Randomized Clinical Trial.

ABSTRACT:

Background

Low back pain (LBP) is the leading cause of disability worldwide. Physical exercise, as a treatment, is beneficial for the improvement of quality of life in patients with LBP, and it is widely accepted.

Objective

We aimed to develop a protocol for a feasibility study that is designed to compare the effectiveness of different interventions in reducing pain, functional, and psychosocial factors among patients with chronic LBP after 8 weeks of randomization.

Methods

This is a study protocol for a randomized controlled trial that will consist of individuals with chronic LBP who are aged between 18 and 65 years. Participants will be allocated, through block randomization, to one of the following groups: the motor control exercises (MCEs), pain education, MCEs+pain education, and usual care groups. The primary outcome will be pain intensity, and the secondary outcomes will be the pressure pain threshold, which will be measured with a digital algometer; LBP-related disability; fears and beliefs; the fear of movement; quality of life; mood states; and levels of depression and anxiety. The trial was approved by the ethics committee for research involving human beings of the Federal University of Pelotas (reference number: 5.717.390) in September 2022, and it will be conducted until August 2023.

Results

The researchers are being trained to apply the questionnaires and carry out the interventions. Patient recruitment will begin at the end of 2022 and results are expected to be achieved by August 2023.

Conclusions

Our trial will provide preliminary data regarding the feasibility and safety of MCEs and pain education for patients with LBP. It will also provide preliminary outcome data that can be used to identify the most efficient intervention and the level of health care that should be implemented in public health services.

Trial registration

Brazilian Registry of Clinical Trials U1111-1221-4106; https://ensaiosclinicos.gov.br/rg/RBR-2xx2r2/.

International registered report identifier (irrid)

PRR1-10.2196/31345.

SUBMITTER: Junkes-Cunha M

PROVIDER: S-EPMC9664319 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

A Rehabilitation Program for Individuals With Chronic Low Back Pain: Protocol for a Randomized Clinical Trial.

Junkes-Cunha Maíra M Sieczkowska Sofia Mendes SM Vilarino Guilherme Torres GT Bevilacqua Guilherme G Andrade Alexandro A

JMIR research protocols 20221031 10

<h4>Background</h4>Low back pain (LBP) is the leading cause of disability worldwide. Physical exercise, as a treatment, is beneficial for the improvement of quality of life in patients with LBP, and it is widely accepted.<h4>Objective</h4>We aimed to develop a protocol for a feasibility study that is designed to compare the effectiveness of different interventions in reducing pain, functional, and psychosocial factors among patients with chronic LBP after 8 weeks of randomization.<h4>Methods</h4 ...[more]

PMID: 36315232

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Project description:BackgroundMillions of people in Germany suffer from chronic pain, in which course and intensity are multifactorial. Besides physical injuries, certain psychosocial risk factors are involved in the disease process. The national health care guidelines for the diagnosis and treatment of non-specific low back pain recommend the screening of psychosocial risk factors as early as possible, to be able to adapt the therapy to patient needs (e.g., unimodal or multimodal). However, such a procedure has been difficult to implement in practice and has not yet been integrated into the rehabilitation care structures across the country.MethodsThe aim of this study is to implement an individualized therapy and aftercare program within the rehabilitation offer of the German Pension Insurance in the area of orthopedics and to examine its success and sustainability in comparison to the previous standard aftercare program. The study is a multicenter randomized controlled trial including 1204 patients from six orthopedic rehabilitation clinics. A 2:1 allocation ratio to intervention (individualized and home-based rehabilitation aftercare) versus the control group (regular outpatient rehabilitation aftercare) is set. Upon admission to the rehabilitation clinic, participants in the intervention group will be screened according to their psychosocial risk profile. They could then receive either unimodal or multimodal, together with an individualized training program. The program is instructed in the clinic (approximately 3 weeks) and will continue independently at home afterwards for 3 months. The success of the program is examined by means of a total of four surveys. The co-primary outcomes are the Characteristic Pain Intensity and Disability Score assessed by the German version of the Chronic Pain Grade questionnaire (CPG).DiscussionAn improvement in terms of pain, work ability, patient compliance, and acceptance in our intervention program compared to the standard aftercare is expected. The study contributes to provide individualized care also to patients living far away from clinical centers.Trial registrationDRKS, DRKS00020373 . Registered on 15 April 2020.

Project description:BackgroundThere is strong, internationally confirmed evidence for the short-term effectiveness of multimodal interdisciplinary specific treatment programs for chronic back pain. However, the verification of long-term sustainability of achieved effects is missing so far. For long-term improvement of pain and functional ability high intervention intensity or high volume seems to be necessary (> 100 therapy hours). Especially in chronic back pain rehabilitation, purposefully refined aftercare treatments offer the possibility to intensify positive effects or to increase their sustainability. However, quality assured goal-conscious specific aftercare programs for the rehabilitation of chronic back pain are absent.Methods/designThis study aims to examine the efficacy of a specially developed bio-psycho-social chronic back pain specific aftercare intervention (RÜCKGEWINN) in comparison to the current usual aftercare (IRENA) and a control group that is given an educational booklet addressing pain-conditioned functional ability and back pain episodes. Overall rehabilitation effects as well as predictors for compliance to the aftercare programs are analysed. Therefore, a multicenter prospective 3-armed randomised controlled trial is conducted. 456 participants will be consecutively enrolled in inpatient and outpatient rehabilitation and assigned to either one of the three study arms. Outcomes are measured before and after rehabilitation. Aftercare programs are assessed at ten month follow up after dismissal form rehabilitation.DiscussionSpecial methodological and logistic challenges are to be mastered in this trial, which accrue from the interconnection of aftercare interventions to their residential district and the fact that the proportion of patients who take part in aftercare programs is low. The usability of the aftercare program is based on the transference into the routine care and is also reinforced by developed manuals with structured contents, media and material for organisation assistance as well as training manuals for therapists in the aftercare.

Project description:Chronic back pain is a major public health problem and the primary reason patients seek acupuncture treatment. Therefore, an objective assessment of acupuncture efficacy is critical for making informed decisions about its appropriate role for patients with this common condition. This study addresses methodological shortcomings that have plagued previous studies evaluating acupuncture for chronic low back pain.A total of 640 participants (160 in each of four arms) between the ages of 18 and 70 years of age who have low back pain lasting at least 3 months will be recruited from integrated health care delivery systems in Seattle and Oakland. They will be randomized to one of two forms of Traditional Chinese Medical (TCM) acupuncture needling (individualized or standardized), a "control" group (simulated acupuncture), or to continued usual medical care. Ten treatments will be provided over 7 weeks. Study participants and the "Diagnostician" acupuncturists who evaluate participants and propose individualized treatments will be masked to the acupuncture treatment actually assigned each participant. The "Therapist" acupuncturists providing the treatments will not be masked but will have limited verbal interaction with participants. The primary outcomes, standard measures of dysfunction and bothersomeness of low back pain, will be assessed at baseline, and after 8, 26, and 52 weeks by telephone interviewers masked to treatment assignment. General health status, satisfaction with back care, days of back-related disability, and use and costs of healthcare services for back pain will also be measured. The primary analysis comparing outcomes by randomized treatment assignment will be analysis of covariance adjusted for baseline value. For both primary outcome measures, this trial will have 99% power to detect the presence of a minimal clinically significant difference among all four treatment groups and over 80% power for most pairwise comparisons. Secondary analyses will compare the proportions of participants in each group that improve by a clinically meaningful amount.Results of this trial will help clarify the value of acupuncture needling as a treatment for chronic low back pain.Clinical Trials.gov NCT00065585.

Project description:BackgroundNon-specific chronic low back pain (NSCLBP) refers to a complex condition that involves structural, biomechanical, cognitive, psychological, social, and lifestyle issues. First-line therapies include physical therapy and exercise, as well as psychological follow-up and pain medication.AimThe aim of this study was to assess the impact of a 6-week center-based program using a multi-axis motorized platform (HUBER) connected with force sensors, that allows the patients to execute isometric exercises on the spine flexion-to-extension ratio at 60 and 120°/s, pain, trunk flexibility, and disability.DesignThe design of the study was prospective, active control, parallel-group, assessor-blinded, randomized controlled trial.SettingThe setting was outpatients physical therapy clinic.PopulationThe population analyzed presented NSCLBP.MethodsSeventy individuals with NSCLBP were randomized into 2 intervention arms (1:1 ratio): 1/standard rehabilitation group (STAND) with physiotherapy, balneotherapy and cycloergometer exercises and 2/HUBER rehabilitation group (HUB) with physiotherapy, balneotherapy and HUBER exercises. Both programs lasted 6 weeks, with 4 sessions of 2 hours each per week.ResultsEach group reported statistically significant improvements on the isokinetic spine strength, flexibility of the trunk, lumbar joint mobility, muscular endurance of the trunk and of the lower limbs, pain score and disability (P<0.05). The spine flexion/extension ratio at 60˚/s improved similarly between groups (-22.23 for HUB, and -13.04 for STAND; P=0.178) with a greater effect size in HUB. Only HUB reported a significant improvement in the spine flexion-to-extension ratio at 120˚/s (from 87.3 to 78.6, P=0.012). HUB reported a greater decrease in the Oswestry Disability Index (-16.83) compared to STAND (-12.11), with a statistically significant effect between groups (P=0.036).ConclusionsExercises performed on the HUBER platform added to physiotherapy and balneotherapy are as effective as a standard rehabilitation program with physiotherapy, balneotherapy and cycloergometer exercises to improve isokinetic spine strength, lumbar joint mobility, flexibility and muscular endurance of the trunk and the lower limbs. In addition, exercising with the HUBER platform result in a greater reduction in disability compared to a standard rehabilitation program (clinicalTrials.gov: NCT05437016).Clinical rehabilitation impactA variety of intervention techniques, including supervised exercise and manual therapy are now used to manage persistent NSCLBP. The added value of the HUBER device on disability suggests that the platform could be beneficial.

Project description:ImportanceTreatment of chronic low back pain (LBP) in older adults is limited by the adverse effects of analgesics. Effective nonpharmacologic treatment options are needed.ObjectiveTo determine the effectiveness of a mind-body program at increasing function and reducing pain in older adults with chronic LBP.Design, setting, and participantsThis single-blind, randomized clinical trial compared a mind-body program (n = 140) with a health education program (n = 142). Community-dwelling older adults residing within the Pittsburgh metropolitan area were recruited from February 14, 2011, to June 30, 2014, with 6-month follow-up completed by April 9, 2015. Eligible participants were 65 years or older with functional limitations owing to their chronic LBP (≥11 points on the Roland and Morris Disability Questionnaire) and chronic pain (duration ≥3 months) of moderate intensity. Data were analyzed from March 1 to July 1, 2015.InterventionsThe intervention and control groups received an 8-week group program followed by 6 monthly sessions. The intervention was modeled on the Mindfulness-Based Stress Reduction program; the control program, on the "10 Keys" to Healthy Aging.Main outcomes and measuresFollow-up occurred at program completion and 6 months later. The score on the Roland and Morris Disability Questionnaire was the primary outcome and measured functional limitations owing to LBP. Pain (current, mean, and most severe in the past week) was measured with the Numeric Pain Rating Scale. Secondary outcomes included quality of life, pain self-efficacy, and mindfulness. Intent-to-treat analyses were conducted.ResultsOf 1160 persons who underwent screening, 282 participants enrolled in the trial (95 men [33.7%] and 187 women [66.3%]; mean [SD] age,74.5 [6.6] years). The baseline mean (SD) Roland and Morris Disability Questionnaire scores for the intervention and control groups were 15.6 (3.0) and 15.4 (3.0), respectively. Compared with the control group, intervention participants improved an additional -1.1 (mean, 12.1 vs 13.1) points at 8 weeks and -0.04 (mean, 12.2 vs 12.6) points at 6 months (effect sizes, -0.23 and -0.08, respectively) on the Roland and Morris Disability Questionnaire. By 6 months, the intervention participants improved on the Numeric Pain Rating Scale current and most severe pain measures an additional -1.8 points (95% CI, -3.1 to -0.05 points; effect size, -0.33) and -1.0 points (95% CI, -2.1 to 0.2 points; effect size, -0.19), respectively. The changes in Numeric Pain Rating Scale mean pain measure after the intervention were not significant (-0.1 [95% CI, -1.1 to 1.0] at 8 weeks and -1.1 [95% CI, -2.2 to -0.01] at 6 months; effect size, -0.01 and -0.22, respectively).Conclusions and relevanceA mind-body program for chronic LBP improved short-term function and long-term current and most severe pain. The functional improvement was not sustained, suggesting that future development of the intervention could focus on durability.Trial registrationclinicaltrials.gov Identifier: NCT01405716.

Project description:ObjectiveChronic low back pain represents a substantial cost to employers through benefits coverage and days missed due to incapacity. We sought to explore the effectiveness of Naturopathic care on chronic low back pain.MethodsThis study was a randomized clinical trial. We randomized 75 postal employees with low back pain of longer than six weeks duration to receive Naturopathic care (n = 39) or standardized physiotherapy (n = 36) over a period of 12 weeks. The study was conducted in clinics on-site in postal outlets. Participants in the Naturopathic care group received dietary counseling, deep breathing relaxation techniques and acupuncture. The control intervention received education and instruction on physiotherapy exercises using an approved education booklet. We measured low back pain using the Oswestry disability questionnaire as the primary outcome measure, and quality of life using the SF-36 in addition to low back range of motion, weight loss, and Body Mass Index as secondary outcomes.ResultsSixty-nine participants (92%) completed eight weeks or greater of the trial. Participants in the Naturopathic care group reported significantly lower back pain (-6.89, 95% CI. -9.23 to -3.54, p = <0.0001) as measured by the Oswestry questionnaire. Quality of life was also significantly improved in the group receiving Naturopathic care in all domains except for vitality. Differences for the aggregate physical component of the SF-36 was 8.47 (95% CI, 5.05 to 11.87, p = <0.0001) and for the aggregate mental component was 7.0 (95% CI, 2.25 to 11.75, p = 0.0045). All secondary outcomes were also significantly improved in the group receiving Naturopathic care: spinal flexion (p<0.0001), weight-loss (p = 0.0052) and Body Mass Index (-0.52, 95% CI, -0.96 to -0.08, p = 0.01).ConclusionsNaturopathic care provided significantly greater improvement than physiotherapy advice for patients with chronic low back pain.Trial registrationControlled-Trials.com ISRCTN41920953.

Dataset Information

A Rehabilitation Program for Individuals With Chronic Low Back Pain: Protocol for a Randomized Clinical Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

A Rehabilitation Program for Individuals With Chronic Low Back Pain: Protocol for a Randomized Clinical Trial.

Similar Datasets

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