Dataset Information

Manual therapy versus therapeutic exercise in non-specific chronic neck pain: study protocol for a randomized controlled trial.

ABSTRACT:

Background

The underlying mechanisms of non-specific chronic neck pain relapses are not clear, but they could be associated with a deficit and alteration of neck muscles propioception that play a decisive role in cervical joint position, motor control of the head, and postural stability. Numerous treatments for non-specific chronic neck pain have been described in the scientific literature. However, few studies analyze its influence on postural stability, since these alterations are not fully described, and various theories emerge about the reasons that cause it. Our primary aim is to analyze the differences in postural stability, pain, cervical disability, and the relation between them produced by a treatment based on manual therapy and another based on therapeutic exercise.

Methods

The short-term and mid-term changes produced by different therapies on subjects with non-specific chronic neck pain will be studied. The sample will be randomly divided into three groups: manual therapy, therapeutic exercise, and placebo. As dependent variables of the study, we will take (1) Overall Balance Index, measured through a dynamic stabilometric platform; (2) pain, based on the visual analog scale and the Pressure Pain Threshold; (3) cervical disability, through the neck disability index. The findings will be analyzed statistically considering a 5% significance level (p???0.05).

Discussion

Our study aims to provide knowledge about postural stability and its relationship with pain in subjects with non-specific chronic neck pain. Analyzing the results produced by different types of therapy will allow us to draw conclusions about the mechanisms, structural or central, that may elicit these alterations.

Trial registration

Brazilian Clinical Trials Registry, RBR-2vj7sw . Registered on 28 November 2018.

SUBMITTER: Bernal-Utrera C

PROVIDER: S-EPMC6688373 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Publications

Manual therapy versus therapeutic exercise in non-specific chronic neck pain: study protocol for a randomized controlled trial.

Bernal-Utrera Carlos C González-Gerez Juan José JJ Saavedra-Hernandez Manuel M Lérida-Ortega Miguel Ángel MÁ Rodríguez-Blanco Cleofás C

Trials 20190809 1

<h4>Background</h4>The underlying mechanisms of non-specific chronic neck pain relapses are not clear, but they could be associated with a deficit and alteration of neck muscles propioception that play a decisive role in cervical joint position, motor control of the head, and postural stability. Numerous treatments for non-specific chronic neck pain have been described in the scientific literature. However, few studies analyze its influence on postural stability, since these alterations are not ...[more]

PMID: 31399143

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Project description:BackgroundNeck pain is a highly prevalent medical condition that incurs substantial social burden. Although manual therapy is widely used for treatment of neck pain, the body of evidence supporting its effectiveness and safety is not conclusive. The aim of this study is to examine the effect, safety, and cost-effectiveness of Chuna manual therapy, a traditional Korean manual therapy for treatment of various musculoskeletal complaints.Methods/designThis study is the protocol for a two-armed parallel, assessor-blinded, multicenter, randomized controlled trial. A total 108 patients with chronic neck pain (time to onset ≥ 3 months, numeric rating scale [NRS] of neck pain ≥ 5) will be recruited at five Korean medicine hospital sites. Participants will be allotted to one of two groups (n = 54, respectively): the Chuna manual therapy group, and the usual care (conventional physical therapy and medication treatment) group. Ten sessions of Chuna manual therapy or usual care will be administered twice a week for five weeks. Since the study design does not permit patient or physician blinding, the outcome assessor and statistician will be blinded. The primary outcome will be the visual analogue scale (VAS) of neck pain at 5 weeks after randomization. Secondary outcomes include the VAS of radiating arm pain, NRS of neck pain and radiating arm pain, Vernon-Mior neck disability index (NDI), Northwick Park neck pain questionnaire (NPQ), EuroQol-5 Dimension (EQ-5D), EQ-VAS, patient global impression of change (PGIC), economic evaluation, adverse effects, and drug consumption. Follow-up outcome assessments will be conducted at 3, 6, 9, and 12 months after randomization.DiscussionThis study will evaluate the comparative effectiveness of Chuna manual therapy and usual care on chronic neck pain. Adverse events, and costs and effectiveness (utility) data will be evaluated to assess safety and exploratory cost-effectiveness (economic evaluation). This study aims to provide evidence on the effectiveness, safety, and cost-effectiveness of Chuna manual therapy.Trial registrationClinical Research Information Service (CRIS), KCT0002732 . Registered on 13 March 2018. ClinicalTrials.gov, NCT03294785 . Registered on 27 September 2017.

Project description:BackgroundNeck-specific exercises (NSE) supervised by a physiotherapist twice a week for 12 weeks have shown good results in chronic whiplash-associated disorders (WADs), but the effect of exercise delivered via the internet is unknown.ObjectiveThis study examined whether NSE with internet support (NSEIT) and 4 physiotherapy sessions for 12 weeks were noninferior to the same exercises supervised by a physiotherapist twice a week for 12 weeks (NSE).MethodsIn this multicenter randomized controlled noninferiority trial with masked assessors, we recruited adults aged 18-63 years with chronic WAD grade II (ie, neck pain and clinical musculoskeletal signs) or III (ie, grade II plus neurological signs). Outcomes were measured at baseline and at 3- and 15-month follow-ups. The primary outcome was change in neck-related disability, measured with the Neck Disability Index (NDI; 0%-100%), with higher percentages indicating greater disability. Secondary outcomes were neck and arm pain intensity (Visual Analog Scale [VAS]), physical function (Whiplash Disability Questionnaire [WDQ] and Patient-Specific Functional Scale [PSFS]), health-related quality of life (EQ-5D-3L and EQ VAS), and self-rated recovery (Global Rating Scale [GRS]). The analyses were conducted on an intention-to-treat basis and with the per-protocol approach as sensitivity analyses.ResultsBetween April 6, 2017, and September 15, 2020, 140 participants were randomly assigned to the NSEIT group (n=70) or the NSE group (n=70); 63 (90%) and 64 (91%), respectively, were followed up at 3 months, and 56 (80%) and 58 (83%), respectively, at 15 months. NSEIT demonstrated noninferiority to NSE in the primary outcome NDI, as the 1-sided 95% CI of the mean difference in change did not cross the specified noninferiority margin (7 percentage units). There were no significant between-group differences in change in NDI at the 3- or 15-month follow-up, with a mean difference of 1.4 (95% CI -2.5 to 5.3) and 0.9 (95% CI -3.6 to 5.3), respectively. In both groups, the NDI significantly decreased over time (NSEIT: mean change -10.1, 95% CI -13.7 to -6.5, effect size=1.33; NSE: mean change -9.3, 95% CI -12.8 to -5.7, effect size=1.19 at 15 months; P<.001). NSEIT was noninferior to NSE for most of the secondary outcomes except for neck pain intensity and EQ VAS, but post hoc analyses showed no differences between the groups. Similar results were seen in the per-protocol population. No serious adverse events were reported.ConclusionsNSEIT was noninferior to NSE in chronic WAD and required less physiotherapist time. NSEIT could be used as a treatment for patients with chronic WAD grades II and III.Trial registrationClinicalTrials.gov NCT03022812; https://clinicaltrials.gov/ct2/show/NCT03022812.

Project description:IntroductionNeck-specific exercises (NSEs) are commonly used for the treatment of chronic non-specific neck pain (CNSNP). However, it remains unclear whether baseline features can predict the response to neck-specific exercise (NSE) in people with CNSNP. This systematic review aims to assess whether baseline features such as age, gender, muscle activity, fatigability, endurance and fear of movement can predict pain and disability reduction following a NSE intervention.Methods and analysisThis systematic review and meta-analysis will be reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Protocols guidelines checklist. The Web of Science, PubMed, Scopus, MEDLINE, Embase and CINAHL databases; key journals; and grey literature will be searched up until June 2023, including medical subject heading terms and keywords combinations. Included studies will investigate an association between the baseline features and pain and disability outcomes following NSE in people with CNSNP. Two independent reviewers will oversee the searching, screening, data extraction and assessment of risk of bias. The risk of bias will be assessed using the Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I) and Risk-Of-Bias tool for randomised trials 2 (ROB 2). The quality of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach (GRADE). Using standardised forms, details regarding study characteristics, baseline features (predictive factors), intervention, primary outcome and effect size (OR and 95% CI of each predictive factor and p value) will be extracted from included studies. Meta-analyses will be considered, if the studies are sufficiently homogeneous and if three or more studies investigate the same or comparable factors that predict the same response (pain intensity or disability). In the event that less than three studies investigated the same factors, a narrative synthesis will be conducted.Ethics and disseminationEthical approval will not be required as this review will be based on published studies. The results of this study will be submitted to a peer-reviewed journal and presented at conferences.Prospero registration numberCRD42023408332.

Project description:BackgroundCervical exercise has been shown to be an effective treatment for neck pain, but there is still a need for more clinical trials evaluating the effectiveness of adding manual therapy to the exercise approach. There is a lack of evidence on the effect of these techniques in patients with neck pain and upper cervical rotation restriction.PurposeTo compare the effectiveness of adding manual therapy to a cervical exercise protocol for the treatment of patients with chronic neck pain and upper cervical rotation restriction.MethodsSingle-blind randomized clinical trial. Fifty-eight subjects: 29 for the Manual Therapy+Exercise (MT+Exercise) Group and 29 for the Exercise group. Neck disability index, pain intensity (0-10), pressure pain threshold (kPa), flexion-rotation test (°), and cervical range of motion (°) were measured at the beginning and at the end of the intervention, and at 3-and 6-month follow-ups. The MT+Exercise Group received one 20-min session of manual therapy and exercise once a week for 4 weeks and home exercise. The Exercise Group received one 20-min session of exercise once a week for 4 weeks and home exercise.ResultsThe MT+Exercise Group showed significant better values post-intervention in all variables: neck disability index: 0% patient with moderate, severe, or complete disability compared to 31% in the Exercise Group (p = 0.000) at 6-months; flexion-rotation test (p = 0.000) and pain intensity (p = 0.000) from the first follow-up to the end of the study; cervical flexion (p = 0.002), extension (p = 0.002), right lateral-flexion (p = 0.000), left lateral-flexion (p = 0.001), right rotation (p = 0.000) and left rotation (p = 0.005) at 6-months of the study, except for flexion, with significative changes from 3-months of follow up; pressure pain threshold from the first follow-up to the end of the study (p values range: 0.003-0.000).ConclusionFour 20-min sessions of manual therapy and exercise, along with a home-exercise program, was found to be more effective than an exercise protocol and a home-exercise program in improving the neck disability index, flexion-rotation test, pain intensity, and pressure pain threshold, in the short, medium, and medium-long term in patients with chronic neck pain and upper rotation restriction. Cervical range of motion improved with the addition of manual therapy in the medium and medium-long term. The high dropout rate may have compromised the external validity of the study.

Project description:BackgroundChronic neck pain (CNP) is prevalent, and it reduces functional status and quality of life and is associated with deleterious psychological outcomes in affected individuals. Despite the desirability of massage and its demonstrated effectiveness in CNP treatment, multiple accessibility barriers exist. Caregiver-applied massage has demonstrated feasibility in various populations but has not been examined in Veterans with CNP or compared in parallel to therapist-delivered massage.ObjectiveThis manuscript described the original study design, lessons learned, and resultant design modifications for the Trial Outcomes for Massage: Care Ally-Assisted Versus Therapist-Treated (TOMCATT) study.MethodsTOMCATT began as a 3-arm, randomized controlled trial of 2 massage delivery approaches for Veterans with CNP with measures collected at baseline, 1 and 3 months after intervention, and 6 months (follow-up). Arm I, care ally-assisted massage, consisted of an in-person, 3.5-hour training workshop, an instructional DVD, a printed treatment manual, and three 30-minute at-home care ally-assisted massage sessions weekly for 3 months. Arm II, therapist-treated massage, consisted of two 60-minute sessions tailored to individual pain experiences and treatments per week for 3 months. The treatments followed a standardized Swedish massage approach. Arm III consisted of wait-list control.ResultsRetention and engagement challenges in the first 30 months were significant in the care ally-assisted massage study arm (63% attrition between randomization and treatment initiation) and prompted modification to a 2-arm trial, that is, removing arm I.ConclusionsThe modified TOMCATT study successfully launched and exceeded recruitment goals 2.5 months before the necessary COVID-19 pause and is expected to be completed by early 2023.Trial registrationClinicalTrials.gov NCT03100539; https://clinicaltrials.gov/ct2/show/NCT03100539.International registered report identifier (irrid)DERR1-10.2196/38950.

Dataset Information

Manual therapy versus therapeutic exercise in non-specific chronic neck pain: study protocol for a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Manual therapy versus therapeutic exercise in non-specific chronic neck pain: study protocol for a randomized controlled trial.

Similar Datasets

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