Dataset Information

The effect of two weeks of spinal manipulative therapy and home stretching exercises on pain and disability in patients with persistent or recurrent neck pain; a randomized controlled trial

ABSTRACT:

Background

Recurrent or persistent neck pain affects a vast number of people globally, leading to reduced quality of life and high societal costs. Clinically, it is a difficult condition to manage, and treatment effect sizes are often moderate at best. Activity and manual therapy are first-line treatment options in current guidelines. We aimed to investigate the combination of home stretching exercises and spinal manipulative therapy in a multicentre randomized controlled clinical trial, carried out in multidiscipline ary primary care clinics.

Methods

The treatment modalities utilized were spinal manipulative therapy and home stretching exercises compared to home stretching exercises alone. Both groups received 4 treatments for 2 weeks. The primary outcome was pain, where the subjective pain experience was investigated by assessing pain intensity (NRS − 11) and the quality of pain (McGill Pain Questionnaire). Neck disability and health status were secondary outcomes, measured using the Neck Disability Indexthe EQ-5D, respectively. One hundred thirty-one adult subjects were randomized to one of the two treatment groups. All subjects had experienced persistent or recurrent neck pain the previous 6 months and were blinded to the other group intervention. The clinicians provided treatment for subjects in both group and could not be blinded. The researchers collecting data were blinded to treatment allocation, as was the statistician performing data analyses. An intention-to-treat analysis was used.

Results

Sixty-six subjects were randomized to the intervention group, and sixty-five to the control group. For NRS − 11, a B-coefficient of − 0,01 was seen, indication a 0,01 improvement for the intervention group in relation to the control group at each time point with a p-value of 0,305. There were no statistically significant differences between groups for any of the outcome measures.

Conclusion

Based on the current findings, there is no additional treatment effect from adding spinal manipulative therapy to neck stretching exercises over 2 weeks for patients with persistent or recurrent neck pain.

Trial registration

The trial was registered 03/07/2018 at ClinicalTrials.gov, registration number: NCT03576846.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12891-021-04772-x.

SUBMITTER: Bakken A

PROVIDER: S-EPMC8549416 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundPersistent or recurrent neck pain is, together with other chronic conditions, suggested to be associated with disturbances of the Autonomic Nervous System. Acute effects on the Autonomic Nervous System, commonly measured using Heart Rate Variability, have been observed with manual therapy. This study aimed to investigate the effect on Heart Rate Variability in (1) a combination of home stretching exercises and spinal manipulative therapy versus (2) home stretching exercises alone over 2 weeks in participants with persistent or recurrent neck pain.MethodsA randomized controlled clinical trial was carried out in five multidisciplinary primary care clinics in Stockholm from January 2019 to April 2020. The study sample consisted of 131 participants with a history of persistent or recurrent neck. All participants performed home stretching exercises daily for 2 weeks and were scheduled for four treatments during this period, with the intervention group receiving spinal manipulative therapy in addition to the home exercises. Heart Rate Variability at rest was measured at baseline, after 1 week, and after 2 weeks, with RMSSD (Root mean square of successive RR interval differences) as the primary outcome. Both groups were blinded to the other group intervention. Thus, they were aware of the purpose of the trial but not the details of the "other" intervention. The researchers collecting data were blinded to treatment allocation, as was the statistician performing data analyses. The clinicians provided treatment for participants in both groups and could not be blinded. A linear mixed-effects model with continuous variables and person-specific random intercept was used to investigate the group-time interaction using an intention to treat analysis.ResultsSixty-six participants were randomized to the intervention group and sixty-five to the control group. For RMSSD, a B coefficient of 0.4 (p value: 0.9) was found, indicating a non-significant difference in the regression slope for each time point with the control group as reference. No statistically significant differences were found between groups for any of the Heart Rate Variability indices.ConclusionAdding four treatments of spinal manipulation therapy to a 2-week program of daily stretching exercises gave no significant change in Heart Rate Variability.Trial registrationThe trial was registered 03/07/2018 at ClinicalTrials.gov, registration number: NCT03576846. ( https://pubmed.ncbi.nlm.nih.gov/31606042/ ).

Project description:BACKGROUND CONTEXT:Chronic neck pain is a prevalent and disabling condition among older adults. Despite the large burden of neck pain, little is known regarding the cost-effectiveness of commonly used treatments. PURPOSE:This study aimed to estimate the cost-effectiveness of home exercise and advice (HEA), spinal manipulative therapy (SMT) plus HEA, and supervised rehabilitative exercise (SRE) plus HEA. STUDY DESIGN/SETTING:Cost-effectiveness analysis conducted alongside a randomized clinical trial (RCT) was performed. PATIENT SAMPLE:A total of 241 older adults (?65 years) with chronic mechanical neck pain comprised the patient sample. OUTCOME MEASURES:The outcome measures were direct and indirect costs, neck pain, neck disability, SF-6D-derived quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) over a 1-year time horizon. METHODS:This work was supported by grants from the National Center for Complementary and Integrative Health (#F32AT007507), National Institute of Arthritis and Musculoskeletal and Skin Diseases (#P60AR062799), and Health Resources and Services Administration (#R18HP01425). The RCT is registered at ClinicalTrials.gov (#NCT00269308). A societal perspective was adopted for the primary analysis. A healthcare perspective was adopted as a sensitivity analysis. Cost-effectivenesswas a secondary aim of the RCT which was not powered for differences in costs or QALYs. Differences in costs and clinical outcomes were estimated using generalized estimating equations and linear mixed models, respectively. Cost-effectiveness acceptability curves were calculated to assess the uncertainty surrounding cost-effectiveness estimates. RESULTS:Total costs for SMT+HEA were 5% lower than HEA (mean difference: -$111; 95% confidence interval [CI] -$1,354 to $899) and 47% lower than SRE+HEA (mean difference: -$1,932; 95% CI -$2,796 to -$1,097). SMT+HEA also resulted in a greater reduction of neck pain over the year relative to HEA (0.57; 95% CI 0.23 to 0.92) and SRE+HEA (0.41; 95% CI 0.05 to 0.76). Differences in disability and QALYs favored SMT+HEA. The probability that adding SMT to HEA is cost-effective at willingness to pay thresholds of $50,000 to $200,000 per QALY gained ranges from 0.75 to 0.81. If adopting a health-care perspective, costs for SMT+HEA were 66% higher than HEA (mean difference: $515; 95% CI $225 to $1,094), resulting in an ICER of $55,975 per QALY gained. CONCLUSION:On average, SMT+HEA resulted in better clinical outcomes and lower total societal costs relative to SRE+HEA and HEA alone, with a 0.75 to 0.81 probability of cost-effectiveness for willingness to pay thresholds of $50,000 to $200,000 per QALY.

Project description:BackgroundFollowing surgery for benign nodular goiter, patients may experience neck and shoulder pain, neck pressure and tightness, choking sensation, altered voice function, and dysphagia leading to decreased short-term quality of life (QoL). This single-blinded randomized controlled trial investigated the effect of post-thyroidectomy rehabilitative neck stretching and movement exercises on these variables including QoL.MethodsPatients undergoing thyroid lobectomy or total thyroidectomy were randomized to perform neck stretching and movement exercises three times daily in four weeks following surgery (intervention group) or conventional follow-up without exercises (control group). Outcome measures were scores in the following questionnaires: Disease-specific Thyroid-Related Patient-Reported Outcome (ThyPRO-39) involving symptoms of "sense of fullness in the neck," "pressure in the throat," and "discomfort swallowing" combined in the multi-item Goiter Symptom Scale, the Voice Handicap-Index-10 (VHI-10), neck and shoulder pain measurement by a numeric rating scale (NRS), and General measure of health (EQ-5D-5L). All scores were assessed prior to surgery and one, two, four weeks, and three months after surgery. Data were analyzed using a linear mixed model.ResultsEighty-nine patients were included and randomized to the control (n = 45) or the intervention group (n = 44). At three months after surgery, both the control and the intervention group experienced large to moderate improvements in the Goiter symptom and Hyperthyroid symptom scale of the ThyPRO questionnaire (p < 0.004). No significant between-group differences were found in any of the other applied scales.ConclusionsThis study confirms that patients experience profound improvements in QoL after surgery for benign nodular goiter. However, early post-thyroidectomy neck stretching and movement exercises did not result in further QoL improvement, reduction in pain or less impacted subjective voice function for patients primarily undergoing thyroid lobectomy. Trial Registration Number NCT04645056 ( https://clinicaltrials.gov ).

Project description:BackgroundChronic neck pain is a highly prevalent condition. Learning a relaxation technique is recommended by numerous guidelines for chronic neck pain. Smartphone apps can provide relaxation exercises; however, their effectiveness, especially in a self-care setting, is unclear.ObjectiveThe aim of this pragmatic randomized trial is to evaluate whether app-based relaxation exercises, including audio-based autogenic training, mindfulness meditation, or guided imagery, are more effective in reducing chronic neck pain than usual care alone.MethodsSmartphone owners aged 18 to 65 years with chronic (>12 weeks) neck pain and the previous week's average neck pain intensity ≥4 on the Numeric Rating Scale (0=no pain to 10=worst possible pain) were randomized into either an intervention group to practice app-based relaxation exercises or a control group (usual care and app for data entry only). For both groups, the follow-up data were collected using app-based diaries and questionnaires. The primary outcome was the mean neck pain intensity during the first 3 months based on daily measurements. Secondary outcomes included neck pain based on weekly measurements, pain acceptance, neck pain-related stress, sick-leave days, pain medication intake, and adherence, which were all measured until the 6-month follow-up. For the primary analysis, analysis of covariance adjusted for baseline neck pain intensity was used.ResultsWe screened 748 participants and enrolled 220 participants (mean age 38.9, SD 11.3 years; mean baseline neck pain 5.7, SD 1.3 points). The mean neck pain intensity in both groups decreased over 3 months; however, no statistically significant difference between the groups was found (intervention: 4.1 points, 95% CI 3.8-4.4; control: 3.8 points, 95% CI 3.5-4.1; group difference: 0.3 points, 95% CI -0.2 to 0.7; P=.23). In addition, no statistically significant between-group differences regarding neck pain intensity after 6 months, responder rate, pain acceptance, pain medication intake, or sick-leave days were observed. There were no serious adverse events that were considered related to the trial intervention. In week 12, only 40% (44/110) of the participants in the intervention group continued to practice the exercises with the app.ConclusionsThe study app did not effectively reduce chronic neck pain or keep the participants engaged in exercising in a self-care setting. Future studies on app-based relaxation interventions should take into account the most recent scientific findings for behavior change techniques.Trial registrationClinicalTrials.gov NCT02019134; https://clinicaltrials.gov/ct2/show/NCT02019134.International registered report identifier (irrid)RR2-10.1186/1745-6215-15-490.