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Effects of electroacupuncture frequencies on chronic low back pain in older adults: triple-blind, 12-months protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Low back pain (LBP) is the most frequent complaint in clinical practice. Electroacupuncture treatment may be effective; however, the supporting evidence is still limited, especially in older adults. OBJECTIVE:The current study is a randomized controlled trial that aims to evaluate the clinical efficacy of electroacupuncture in older adults with LBP. METHODS:A five-arm randomized controlled trial with patients and evaluators blinded to the group allocation. A total of 125 participants with non-specific LBP will be randomly assigned into one of five groups: three electroacupuncture groups (low, high, and alternating frequency); one control group; and one placebo group. The electroacupuncture will be applied twice a week (30?min per session) for five?weeks. The primary clinical outcome measure will be pain intensity. The secondary outcomes include: quality of pain; physical functioning; perceived overall effect; emotional functionality; patient satisfaction; and psychosocial factors. Patients will be evaluated before the first session, immediately after the last, and followed up after six and 12?months to check the medium- and long-term effects. DISCUSSION:Although electroacupuncture is increasingly used to treat LBP, there is no guidance regarding the parameters used, which leads to inconsistent results. Thus, the effect of electroacupuncture (EA) on LBP remains controversial and requires more studies, especially in the older adult population. CONCLUSION:This is the first randomized controlled trial to evaluate the efficacy of different frequencies of electroacupuncture for treating chronic LBP in older adults. This study will provide evidence on the effectiveness of electroacupuncture as an alternative treatment method for LBP and will entail wider debate about an appropriate acupuncture intervention in this population. TRIAL REGISTRATION:Clinicaltrials.gov, NCT03802045. Registered on 14 January 2019.

SUBMITTER: Francescato Torres S

PROVIDER: S-EPMC6929454 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Effects of electroacupuncture frequencies on chronic low back pain in older adults: triple-blind, 12-months protocol for a randomized controlled trial.

Francescato Torres Sarina S Brandt de Macedo Ana Carolina AC Dias Antunes Mateus M Merllin Batista de Souza Ingred I Dimitre Rodrigo Pereira Santos Francisco F de Sousa do Espírito Santo Adriana A Ribeiro Jacob Flávia F Torres Cruz Ariela A de Oliveira Januário Priscila P Pasqual Marques Amélia A

Trials 20191223 1

<h4>Background</h4>Low back pain (LBP) is the most frequent complaint in clinical practice. Electroacupuncture treatment may be effective; however, the supporting evidence is still limited, especially in older adults.<h4>Objective</h4>The current study is a randomized controlled trial that aims to evaluate the clinical efficacy of electroacupuncture in older adults with LBP.<h4>Methods</h4>A five-arm randomized controlled trial with patients and evaluators blinded to the group allocation. A tota ...[more]

PMID: 31870456

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Project description:INTRODUCTION:The Pain Toolkit is a self-management tool for people with persistent pain. It is available for use worldwide in multiple formats. To date, no studies have investigated the effectiveness of this intervention. This study aims to investigate the effectiveness of the Pain Toolkit in comparison with a simple education control for people with low back pain. METHODS AND ANALYSIS:Participants who have been discharged from the North of England Regional Back Pain Pathway will be randomised using sealed, consecutively numbered opaque envelopes to receive either the Pain Toolkit and the Back Book (intervention group) or the Back Book only (control group). Both the therapist and the participant will be blind to group allocation. The primary outcome measure will be disability (Oswestry Disability Index (ODI)). Secondary outcome measures will be pain (0-10 numerical scale), healthcare use (number of healthcare professional visits) and quality of life (EuroQol-5D). Outcome measures will be completed at baseline and at 6 and 12 months. Data will be analysed using analysis of covariance, adjusting for baseline values. A change of 10 points in the ODI will be considered a clinically important change. Additionally, a subsample of participants from the intervention group will undergo semistructured interviews to explore individuals' experience of the Pain Toolkit. Participants will be asked questions about the ease of use and acceptability of the Pain Toolkit and also for how long they used the Toolkit. The qualitative data will be analysed using thematic analysis. ETHICS AND DISSEMINATION:Approval for the study was given by the Health Research Authority and the North East Newcastle, North Tyneside 2 Regional Ethics Committee (reference 18/NE/0144) and Teesside University (reference 176/17). Findings will be disseminated through peer-reviewed journals and presentation at relevant patient groups, and local, national and international conferences. TRIAL REGISTRATION NUMBER:NCT03791164; Pre -results.

Project description:BackgroundChronic low back pain (CLBP) is the most common chronic pain condition and is often resistant to conventional treatments. Acupuncture is a popular alternative for treating CLBP but its mechanisms of action remain poorly understood. Evidence suggests that pain regulatory mechanisms (particularly the ascending and secondarily the descending pain modulatory pathways) and psychological mechanisms (e.g., expectations, pain catastrophizing and self-efficacy) may be involved in the pathogenesis of CLBP and its response to treatments. We will examine these mechanisms in the treatment of CLBP by electroacupuncture (EA).MethodsWe present the aims and methods of a placebo-controlled, participant-blinded and assessor-blinded mechanistic study. Adult patients with CLBP will be randomized to receiving 16 sessions of real (active) or sham (placebo) EA over the course of 8 weeks. The primary pain regulatory measure for which the study was powered is temporal summation (TS), which approximates ascending pain facilitation. Conditioned pain modulation (CPM), representing a descending pain modulatory pathway, will be our secondary pain regulatory measure. The primary psychological measure is expectations of benefit, and the secondary psychological measures are pain catastrophizing and self-efficacy in managing pain. Main clinical outcomes are back pain bothersomeness on a 0-100 visual analog scale (primary), Roland Morris Disability Questionnaire (secondary), and relevant items from the National Institutes of Health (NIH) Patient-Reported Outcome Measures Information System (secondary). We hypothesize that compared to sham, real EA will lead to greater reduction in TS after 8 treatment sessions (4 weeks); and that reduction in TS (and secondarily, increase in CPM) after 8 treatment sessions will mediate reduction in back pain bothersomeness from baseline to week 10 (clinical response) to EA. We also hypothesize that the three psychological factors are moderators of clinical response. With 100 treatment completers, the study is designed to have 80% power to detect a medium-sized between-group effect (d = 0.5) on temporal summation.DiscussionTo the best of our knowledge, this is the first appropriately powered, placebo-controlled clinical trial evaluating mechanisms of EA in the treatment of CLBP.Trial registrationClinicalTrials.gov, NCT02503475 . Registered on 15 July 15 2015. Retrospectively registered.

Project description:BackgroundMovement behaviours, such as sedentary behaviour (SB) and moderate to vigorous physical activity (MVPA), are linked with multiple aspects of health and can be influenced by various pain-related psychological factors, such as fear of movement, pain catastrophising and self-efficacy for exercise. However, the relationships between these factors and postoperative SB and MVPA remain unclear in patients undergoing surgery for lumbar degenerative conditions. This study aimed to investigate the association between preoperative pain-related psychological factors and postoperative SB and MVPA in patients with low back pain (LBP) and degenerative disc disorder at 6 and 12 months after lumbar fusion surgery.MethodsSecondary data were collected from 118 patients (63 women and 55 men; mean age 46 years) who underwent lumbar fusion surgery in a randomised controlled trial. SB and MVPA were measured using the triaxial accelerometer ActiGraph GT3X+. Fear of movement, pain catastrophising and self-efficacy for exercise served as predictors. The association between these factors and the relative time spent in SB and MVPA 6 and 12 months after surgery was analysed via linear regression models, adjusting for potential confounders.ResultsPreoperative fear of movement was significantly associated with relative time spent in SB at 6 and 12 months after surgery (β = 0.013, 95% confidence interval = 0.004 to 0.022, p = 0.007). Neither pain catastrophising nor self-efficacy for exercise showed significant associations with relative time spent in SB and MVPA at these time points.ConclusionsOur study demonstrated that preoperative fear of movement was significantly associated with postoperative SB in patients with LBP and degenerative disc disorder. This finding underscores the potential benefits of preoperative screening for pain-related psychological factors, including fear of movement, preoperatively. Such screenings could aid in identifying patients who might benefit from targeted interventions to promote healthier postoperative movement behaviour and improved health outcomes.

Project description:ObjectiveTo compare the effects of 4 months of isolated lumbar resistance exercise and total body resistance exercise on walking performance in obese, older adults with chronic low back pain. A secondary analysis examined whether responsiveness to training modulated walking improvement.DesignRandomized, controlled trial.SettingResearch laboratory affiliated with tertiary care facility.Methods and interventionParticipants (N = 49; 60-85 years) were randomized into a 4-month resistance exercise intervention (TOTRX), lumbar extensor exercise intervention (LEXT), or a control group (CON).Main outcome measurementsWalking performance, maximal low back strength and leg strength, and average resting and low back pain severity score (from an 11-point numerical pain rating scale; NRSpain) were collected at baseline and month 4.ResultsThe TOTRX and LEXT improved lumbar extensor strength relative to CON, and the TOTRX (P < .05). NRSpain scores at month 4 were lowest in the TOTRX group compared with the LEXT and CON groups, respectively (2.0 ± 1.7 points vs 3.7 ± 2.6 points and 4.6 ± 2.4 points; P < .006). A total of 53% and 67% of participants in the TOTRX and LEXT groups were responders who made lumbar extensor strength gains that achieved ≥20% greater than baseline values. Although the TOTRX demonstrated the greatest improvement in walking endurance among the intervention groups, this did not reach significance (10.1 ± 12.2% improvement in TOTRX vs 7.4 ± 30.0% LEXT and -1.7 ± 17.4% CON; P = .11). Gait speed increased most in the TOTRX (9.0 ± 13.5%) compared with the LEXT and CON groups (P < .05). The change in lumbar extensor strength explained 10.6% of the variance of the regression model for the change in walking endurance (P = .024).ConclusionsThe use of LEXT and TOTRX produced similar modest improvements in patients' walking endurance. Lumbar extensor strength gain compared with leg strength gain is a moderate but important contributor to walking endurance in obese older adults with chronic low back pain. Responders to resistance exercise programs (event those with only lumbar extension exercise) who make at least a 20% improvement in strength can expect better improvement in walking endurance than those who do not achieve this strength improvement.

Dataset Information

Effects of electroacupuncture frequencies on chronic low back pain in older adults: triple-blind, 12-months protocol for a randomized controlled trial.

Publications

Effects of electroacupuncture frequencies on chronic low back pain in older adults: triple-blind, 12-months protocol for a randomized controlled trial.

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