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Effectiveness of cooling therapy (cryotherapy) on leg pain and self-efficacy in patients with chronic venous disease: A randomized controlled trial.

ABSTRACT: BACKGROUND:Individuals with chronic venous disease (CVeD) frequently experience associated leg pain that may influence disease management self-efficacy. OBJECTIVE:To evaluate the influence of a cooling intervention on leg pain associated with more severe stages of CVeD and self-efficacy. This was a secondary aim of the trial. DESIGN:Randomized, blinded, comparator-controlled, multisite trial. SETTING:Three wound clinics and an academic medical research center in the United States of America. PARTICIPANTS:276 participants (54.3% female, 46.7% male) with stage 4 and 5 CVeD were randomly assigned by computer generated tables to the cooling intervention group (n?=?138) or control group (n?=?138). INTERVENTIONS:Participants received either a cooling (intervention) leg cuff or placebo cuff (control) to apply topically over the affected skin area. Both groups performed standard of care including wearing compression wraps and elevating legs for 30?min during the intervention. Study visits occurred at baseline, and months 1, 3, 6, and 9. METHODS:Visit measures included: Numeric Rating Scale (NRS) for short term pain; VEINES-QOL/Sym questionnaire for long-term pain; and, the Self Efficacy for Managing Chronic Disease Scale (SEMCD-6) for self-efficacy. Data were collected from September 2010 to December 2015 and analyzed using pooled t-tests, Chi-square tests, and mixed effects models. Observed 9-month patient retention rates were 94/138 (68.1%) in the intervention group and 91/138 (65.9%) in the control group. The primary analysis was based on the intention-to-treat principle. RESULTS:Both the cooling intervention and control group experienced statistically significant decreases in unadjusted and adjusted mean NRS pain scores of 1.2 (95% CI: (-1.82, -0.64); p?

SUBMITTER: Kelechi TJ

PROVIDER: S-EPMC6186183 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Effectiveness of cooling therapy (cryotherapy) on leg pain and self-efficacy in patients with chronic venous disease: A randomized controlled trial.

Kelechi Teresa J TJ Mueller Martina M Madisetti Mohan M Prentice Margie A MA Dooley Mary J MJ

International journal of nursing studies 20180426

<h4>Background</h4>Individuals with chronic venous disease (CVeD) frequently experience associated leg pain that may influence disease management self-efficacy.<h4>Objective</h4>To evaluate the influence of a cooling intervention on leg pain associated with more severe stages of CVeD and self-efficacy. This was a secondary aim of the trial.<h4>Design</h4>Randomized, blinded, comparator-controlled, multisite trial.<h4>Setting</h4>Three wound clinics and an academic medical research center in the ...[more]

PMID: 29957362

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Project description:PurposeThis aim of this study was to evaluate the clinical efficacy of a self-managed cooling intervention in individuals with recently healed venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs) on pain reduction and physical activity improvement.DesignA 6-month longitudinal randomized controlled trial.Subjects and settingThe sample comprised 140 individuals with previously healed VLU and DFU who received care in 3 outpatient wound centers in the Southeastern region of the United States. Participants were randomized to the MUSTCOOL or a placebo cooling patch intervention.MethodsThe cooling and placebo interventions comprised cooling or cotton-filled patch application to recently healed skin for 30 minutes, 3 times weekly plus standard of care including compression and leg elevation (participants with VLU) or therapeutic footwear and hygiene (participants with DFU) over a 6-month period. Pain severity and intensity were measured with the Brief Pain Inventory and physical activity with the International Physical Activity Questionnaire, which assessed metabolic equivalent of tasks (METs) in minutes per week. Minutes in walking time per week were assessed with an accelerometer. Data were descriptively analyzed for difference changes in scores from baseline to 6 months post-intervention.ResultsData were analyzed for 81 participants randomized to cooling and placebo groups (VLUs, n = 26/29) and DFU (n = 12/16). Slight reductions in VLU pain severity (-0.5, -0.2) and interference (-0.4, -0.5) and minimal reductions in DFU pain severity (0, -0.1) and interference (0.4/0.1) were achieved. However, pain scores were low to moderate at baseline (mean 4, 0-10 with 10 worst pain possible) in both groups. For physical activity, the MET values showed low physical activity in both groups at baseline with slight improvements noted in VLU cooling and placebo groups (73/799) and DFU (1921/225), respectively. Walking time for the VLU groups improved by 1420/2523 minutes; the DFU groups improved 135/157 minutes, respectively. Findings for outcomes were not statistically significant within or between groups.ConclusionsApplication of the cooling pack compared to placebo was minimally efficacious in reducing posthealing pain and improving function in this posthealed ulcer population. However for pain, scores were initially low; thus outcomes on pain, while lower, were marginal.Trial registrationThe study was prospectively registered with ClinicalTrials.gov on December 10, 2015 (Identifier: NCT02626156), https://clinicaltrials.gov/ct2/show/NCT02626156 .

Project description:BackgroundExercise and adequate self-management capacity may be important strategies in the management of venous leg ulcers. However, it remains unclear if exercise improves the healing rates of venous leg ulcers and if a self-management exercise program based on self-efficacy theory is well adhered to.Method/designThis is a randomised controlled in adults with venous leg ulcers to determine the effectiveness of a self-efficacy based exercise intervention. Participants with venous leg ulcers are recruited from 3 clinical sites in Australia. After collection of baseline data, participants are randomised to either an intervention group or control group. The control group receive usual care, as recommended by evidence based guidelines. The intervention group receive an individualised program of calf muscle exercises and walking. The twelve week exercise program integrates multiple elements, including up to six telephone delivered behavioural coaching and goal setting sessions, supported by written materials, a pedometer and two follow-up booster calls if required. Participants are encouraged to seek social support among their friends, self-monitor their weekly steps and lower limb exercises. The control group are supported by a generic information sheet that the intervention group also receive encouraging lower limb exercises, a pedometer for self-management and phone calls at the same time points as the intervention group. The primary outcome is the healing rates of venous leg ulcers which are assessed at fortnightly clinic appointments. Secondary outcomes, assessed at baseline and 12 weeks: functional ability (range of ankle motion and Tinetti gait and balance score), quality of life and self-management scores.DiscussionThis study seeks to address a significant gap in current wound management practice by providing evidence for the effectiveness of a home-based exercise program for adults with venous leg ulcers. Theory-driven, evidence-based strategies that can improve an individual's exercise self-efficacy and self-management capacity could have a significant impact in improving the management of people with venous leg ulcers. Information gained from this study will provide much needed information on management of this chronic disease to promote health and independence in this population.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12612000475842.

Project description:BACKGROUND:Individuals with venous leg ulcers (VLUs) suffer disproportionately with multiple chronic conditions, are often physically deconditioned, and demonstrate high levels of physical inactivity. OBJECTIVE:The primary objective of this randomized controlled trial was to establish the feasibility of a mobile health (mHealth) physical activity exercise app for individuals with VLUs to improve lower leg function. METHODS:In a 6-week study, adults with VLUs were recruited from 2 wound centers in South Carolina, United States, and enrolled if they were aged 18 years or older with impaired functional mobility and an ankle-brachial index between 0.8 and 1.3. Participants were randomized 1:1 to receive evidence-based, phased, nonexertive physical conditioning activities for lower leg function (FOOTFIT) or FOOTFIT+ with an added patient-provider communication feature. The mHealth Conditioning Activities for Lower Leg Function app also provided automated educational and motivational messages and user reports. Foot movement on the VLU-affected leg was tracked by a Bluetooth-enabled triaxial accelerometer. The study was guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework to assess the feasibility of reach, adherence, acceptability, implementation, and maintenance. RESULTS:A total of 24 patients were recruited, enrolled, and randomized in the study. Most patients reported difficulty following the protocol for exercising and using the accelerometer and mobile phone and did not use the provider contact feature. However, all patients were adherent to the 6-week exercise program more than 85% of the time for duration, whereas 33% (8/24) of patients adhered more than 85% for the frequency of performing the exercises. Across the three exercise levels, adherence did not differ between the two groups. Confidence limits around the difference in proportions ranged from -0.4 to 0.7. Providers in FOOTFIT+ were inconsistent in checking participant progress reports because of lack of time from competing work commitments. The technology became outdated quickly, making maintenance problematic. Participants said they would continue to exercise their foot and legs and liked being able to follow along with the demonstrations of each level of exercise provided through the app. CONCLUSIONS:The findings of this study suggest that despite initial interest in using the app, several components of the program as originally designed had limited acceptability and feasibility. Future refinements should include the use of more modern technology including smaller wearable accelerometers, mobile phones or tablets with larger screens, an app designed with larger graphics, automated reporting for providers, and more engaging user features. TRIAL REGISTRATION:ClinicalTrials.gov NTC02632695; https://clinicaltrials.gov/ct2/show/NCT02632695.

Project description:Generic self-management programs aim to facilitate behavioural adjustment and therefore have considerable potential for patients with chronic musculoskeletal pain. Our main objective was to collect and synthesize all data on the effectiveness of generic self-management interventions for patients with chronic musculoskeletal pain in terms of physical function, self-efficacy, pain intensity and physical activity. Our secondary objective was to describe the content of these interventions, by means of classification according to the Behaviour Change Technique Taxonomy. We searched PubMed, CENTRAL, Embase and Psycinfo for eligible studies. Study selection, data extraction and risk of bias were assessed by two researchers independently. Meta-analyses were only performed if the studies were sufficiently homogeneous and GRADE was used to determine the quality of evidence. We identified 20 randomized controlled trials that compared a self-management intervention to any type of control group. For post-intervention results, there was moderate quality evidence of a statistically significant but clinically unimportant effect for physical function and pain intensity, both favouring the self-management group. At follow-up, there was moderate quality evidence of a small clinically insignificant effect for self-efficacy, favouring the self-management group. All other comparisons did not indicate an effect. Classification of the behaviour change techniques showed large heterogeneity across studies. These results indicate that generic self-management interventions have a marginal benefit for patients with chronic musculoskeletal pain in the short-term for physical function and pain intensity and for self-efficacy in the long-term, and vary considerably with respect to intervention content. SIGNIFICANCE:This study contributes to a growing body of evidence that generic self-management interventions have limited effectiveness for patients with chronic musculoskeletal pain. Furthermore, this study has identified substantial differences in both content and delivery mode across self-management interventions.

Dataset Information

Effectiveness of cooling therapy (cryotherapy) on leg pain and self-efficacy in patients with chronic venous disease: A randomized controlled trial.

Publications

Effectiveness of cooling therapy (cryotherapy) on leg pain and self-efficacy in patients with chronic venous disease: A randomized controlled trial.

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