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Managing nocturnal leg cramps--calf-stretching exercises and cessation of quinine treatment: a factorial randomised controlled trial.

ABSTRACT: BACKGROUND: Quinine is a common treatment for nocturnal leg cramps but has potential side effects. An uncontrolled study suggested that calf-stretching exercises could prevent nocturnal leg cramps (night cramps) but these findings have never been confirmed. AIM: To assess the effect of calf-stretching exercises and cessation of quinine treatment for patients with night cramps taking quinine. DESIGN OF STUDY: Randomised controlled trial. SETTING: Twenty-eight general practices in southern England. METHOD: One hundred and ninety-one patients prescribed quinine for night cramps were randomised to one of four groups defined by two "advice" factors: undertake exercises and stop quinine. After 6 weeks they were advised that they could take quinine and undertake the exercises freely. Documentation of cramp at 12 weeks was achieved in 181 (95%) patients. Main outcome measures were: symptom burden score, and frequency of night cramps and quinine usage. RESULTS: At 12 weeks there was no significant difference in number of cramps in the previous 4 weeks (exercise = 1.95, 95% confidence interval [CI] = -3.01 to 6.90; quinine cessation = 3.45, 95% CI = -1.52 to 8.41) nor symptom burden or severity of cramps. However, after 12 weeks 26.5% (95% CI = 13.3% to 39.7%) more patients who had been advised to stop quinine treatment reported taking no quinine tablets in the previous week (odds ratio [OR] = 3.32, 95% CI = 1.37 to 8.06), whereas advice to do stretching exercises had no effect (OR = 0.73, 95% CI = 0.27 to 1.98). CONCLUSIONS: Calf-stretching exercises are not effective in reducing the frequency or severity of night cramps. Advising those on long-term repeat prescriptions to try stopping quinine temporarily will result in no major problems for patients, and allow a significant number to stop medication.

SUBMITTER: Coppin RJ

PROVIDER: S-EPMC1463088 | biostudies-other | 2005 Mar

REPOSITORIES: biostudies-other

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Managing nocturnal leg cramps--calf-stretching exercises and cessation of quinine treatment: a factorial randomised controlled trial.

Coppin Richard J RJ Wicke Dorothy M DM Little Paul S PS

The British journal of general practice : the journal of the Royal College of General Practitioners 20050301 512

<h4>Background</h4>Quinine is a common treatment for nocturnal leg cramps but has potential side effects. An uncontrolled study suggested that calf-stretching exercises could prevent nocturnal leg cramps (night cramps) but these findings have never been confirmed.<h4>Aim</h4>To assess the effect of calf-stretching exercises and cessation of quinine treatment for patients with night cramps taking quinine.<h4>Design of study</h4>Randomised controlled trial.<h4>Setting</h4>Twenty-eight general prac ...[more]

PMID: 15808033

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Project description:BackgroundLow completion rates of questionnaires in randomised controlled trials can compromise the reliability of the results, so ways to boost questionnaire completion are often implemented. Although there is evidence to suggest that sending a text message to participants increases completion, there is little evidence around the timing or personalisation of these text messages. Methods: A two-by-two factorial SWAT (study within a trial) was embedded within the MiQuit-3 trial, looking at smoking cessation within pregnant smokers. Participants who reached their 36-week gestational follow-up were randomised to receive a personalised or non-personalised text message, either one week or one day prior to their follow-up. Primary outcomes were completion rate of questionnaire via telephone. Secondary outcomes included: completion rate via any method, time to completion, and number of attempts to contact required. Results In total 194 participants were randomised into the SWAT to receive a text message that was personalised early(n=50), personalised late (n=47), non-personalised early(n=50), or non-personalised late(n=47). There was no evidence that timing of the text message (early: one week before; or late: one day before) had an effect on any of the outcomes. There was evidence that a personalised text message would result in fewer completions compared with a non-personalised text message when data was collected only via the telephone(adjusted OR 0.44, 95% CI 0.22-0.87, p=0.02). However, these results were not significant when looking at completion via any method (adjusted OR 0.61, 95% CI 0.30-1.24, p=0.17). There was no evidence to show that personalisation or not was better for any of the secondary outcomes. Conclusion Timing of the text message does not appear to influence the completion of questionnaires. Personalisation of a text message may be detrimental to questionnaire completion, if data is only collected via the telephone - however, more SWATs should be undertaken in this field.

Project description:Importance:Magnesium supplements are widely marketed for prophylaxis of nocturnal leg cramps (NLC) despite no evidence of significant benefit. Objective:To determine whether magnesium oxide is better than placebo for NLC prophylaxis. Design, Setting, and Participants:A randomized, double-blind, placebo-controlled clinical trial of 2 weeks eligibility screening followed by 4 weeks of treatment was conducted in northern Israel, from February to October 2013. An intention-to-treat data analysis was performed from March 22, 2014, to April 17, 2016. We used a volunteer sample of community-dwelling individuals experiencing NLC, 21 years or older, with 4 or more documented episodes of NLC during 2 weeks of screening. Interventions:Capsules containing either magnesium oxide or a similar-looking placebo to be taken orally, once daily at bedtime for a period of 4 weeks. Main Outcomes and Measures:The primary outcome was the difference in the mean number of NLC per week between the screening and treatment phases. Secondary outcomes included severity and duration of NLC, quality of life, and quality of sleep. Results:Of the 166 volunteers, 72 (43%) were excluded, of whom 15 declined to participate and 57 did not meet the inclusion criteria. Of the 94 individuals (39% male; mean [SD] age, 64.9 [11.1] years) randomly assigned to magnesium oxide (48) or placebo (46), 6 did not complete the study protocol (3 in each group). Mean (SD) change of NLC was -3.41 (4.05) (from 7.84 [5.68] to 4.44 [5.66]) and -3.03 (4.53) (from 8.51 [5.20] to 5.48 [4.93]) per week in the magnesium oxide and placebo groups, respectively, a difference between groups of 0.38 (0.48) NLC per week (P?=?.67 in an intention-to-treat analysis). There were no between-group differences in the severity and duration of NLC, quality of life, or quality of sleep. Conclusions and Relevance:Oral magnesium oxide was not superior to placebo for older adults experiencing NLC. The decrease in the mean number of NLC per week, from the screening to the treatment phase in both groups, is probably a placebo effect that may explain the wide use of magnesium for NLC. Trial Registration:clinicaltrials.gov Identifier: NCT01709968.

Project description:BackgroundMuscle stretching exercises preserve corporal flexibility and decrease the retraction and shortening of myofascial and articular structures. These exercises are recommended for the treatment of fibromyalgia (FM). The purpose of the study was to verify and compare the effect of muscle stretching exercises on FM patients based on the global posture reeducation method against segmental muscle stretching exercises, both used in concert with an educational approach rooted in cognitive behavioral therapy.MethodsForty adults with FM were randomly allocated into two groups: global and segmental. The two kinds of therapies were performed in 10 individual sessions once a week. Two assessments were made: one at baseline and one at the end of therapy. The primary outcome variable was pain intensity (Visual Analog Scale). The secondary outcome variables were multidimensional pain (McGill Pain Questionnaire), the pain threshold at tender points (dolorimetry), attitudes toward chronic pain (Survey of Pain Attitudes-Brief Version), body posture (Postural Assessment Software Protocol), postural control (Modified Clinical Test of Sensory Interaction on Balance), flexibility (sit-and-reach test), the impact of FM on quality of life (Fibromyalgia Impact Questionnaire, FIQ), and self-reported perceptions and body self-care.ResultsAt the end of treatment, there were no statistically significant differences between the groups in the outcome variables. Furthermore, the groups presented lower pain intensity (baseline vs. final; global group: 6 ± 1.8 vs. 2.2 ± 1.6 cm, p<0.01; segmental group: 6.3 ± 2.1 vs. 2.5 ± 1.7 cm, p<0.01), higher pain threshold (p ≤ 0.01), lower total FIQ score (p < 0.01), and greater postural control (p < 0.01) after treatment.ConclusionsMuscle stretching exercises based on global posture reeducation and segmental muscle stretching exercises, both used in concert with an educational approach rooted in cognitive behavioral therapy, reduced the pain intensity and impact of FM on quality of life. These exercises also improved FM patients' pain threshold at tender points, attitudes toward chronic pain, and postural control. There were no differences between global posture reeducation and segmental muscle stretching exercises.Trial registrationClinicalTrials.gov NCT02384603 . Registered on 10 March 2015.

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Managing nocturnal leg cramps--calf-stretching exercises and cessation of quinine treatment: a factorial randomised controlled trial.

Publications

Managing nocturnal leg cramps--calf-stretching exercises and cessation of quinine treatment: a factorial randomised controlled trial.

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