None listed
Conditions
Brief summary
Night-time muscle cramps affects about 1 in 3 adults. These cramps reduce quality of life and sleep, sometimes severely. A recent Cochrane review of non-drug therapies found some evidence of effectiveness of stretching in reducing the frequency of night-time calf cramps, though deficiencies in the stretching protocol and study designs reduce certainty of the evidence. Our previous research identifies a potential mechanism of benefit of stretching for muscle cramps, as well as other potentially effective, low cost and low risk educational interventions that align with the scientific understanding of cramp pathophysiology. We propose to undertake a randomised feasibility trial of lower limb stretching and cramps prevention education for night-time calf cramps. We will recruit 26 to 40 adults who experience night-time calf muscle cramp at least twice per week and who do not have known neurological disease. Approximately 13 to 20 people will be randomly assigned to a combination of calf and hamstring stretching plus receive cramps and cramps-prevention education. Approximately 13 to 20 people will be randomly assigned to sham stretching and cramps education (no cramps prevention education). Intervention duration will be 6 weeks. The primary outcome of the study is to determine the feasibility of conducting a full-scale RCT. The secondary outcome was to investigate limited efficacy testing of the effect of the intervention on cramp frequency and severity (as recorded in a cramp diary), quality of sleep, and quality of life.
Interventions
We will recruit 40 adults who experience night-time calf muscle cramp at least twice per week and who do not have known neurological disease. Twenty people will be randomly assigned to a combination of calf and hamstring stretching plus receive cramps-prevention education. The stretching group will be shown how to perform hamstring/calf stretches. Participants will be asked to perform stretches twice per day; once before bed and once again throughout the day at a time of their choosing. Particip
We will recruit 40 adults who experience night-time calf muscle cramp at least twice per week and who do not have known neurological disease. Twenty people will be randomly assigned to a combination of calf and hamstring stretching plus receive cramps-prevention education. The stretching group will be shown how to perform hamstring/calf stretches. Participants will be asked to perform stretches twice per day; once before bed and once again throughout the day at a time of their choosing. Participants will stretch both legs, one at a time. Each stretch will be held for 1 min and repeated once in each stretching session (a total of 4 minutes stretching each stretching session). Participants will receive education about what cramps are and will be encouraged to keep the lower limbs warm at night. Participants will be told that this could be achieved by wearing long pyjama pants, wool socks tucked into pyjama pants and potentially wool leg warmers pulled up over their knees. Participants will be told that in order to keep lower extremities warm, the core body temperature must also be warm, so to use adequate bedding on cool nights. Participants will also be encouraged to avoid days of very high and very low activity, and to instead aim for a fairly consistent amount of moderate exercise each day. They will also be told that, if they notice muscle twitching in the calf muscle, stretch the muscle by straightening the knee and moving the toes towards the shin. They will also be advised to sleep, when comfortable, with calf muscle on slight stretch by tucking the toes up towards the shins – either by resting the bottom of the toes against the bedding (if lying on back) or on the bed (if lying on stomach). They will also be told that, when waking in the morning, if inclined to stretch the legs, to do so by straightening the knee and moving the toes towards the shin. Participants will be educated to avoid pointing the toes whilst performing the above stretch. This information will be delivered once, face to face by lead researcher (EC) at week 0 appointment and will also be available in written form in the front page of stretching handbook provided. Participants will log stretching adherence in stretching handbook provided and also encouraged to complete stretching and log stretching via phone calls made by lead researcher (EC) during the trial period. Total duration of the intervention is 6 weeks. Adherence will be logged in a handbook provided.
Sponsors
University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age 18 years and older People experiencing night-time calf cramps at least twice per week. Frequency of cramps will be recorded for 2 weeks prior to enrolment and receiving group allocation. Muscle cramps will be defined as a sudden, involuntary and painful contraction of muscle that gradually lessens. During cramp, the affected muscle hardens and joints can be forced into unusual positions. In some people, cramp can be brought on by certain movements and/or stopped by stretching the muscle. During the first phone conversation and reiterated in person before enrolling, Erin Croft will attempt to differentiate cramp from other foot and leg problems that occur at night, for example: • Muscle cramp is different to restless leg syndrome, in which people experience an urge to move their legs. Restless leg syndrome is not very painful and does not involve hardening of the muscle. • Muscle cramp is different to ‘ischaemic rest pains’ that occur directly because of low blood flow while lying down, in which a general ache occurs and muscles do not harden and joints to not move. Both cramp and ‘rest pain’ may be relieved by standing. • Muscle cramp is different to hypnagogic jerks, in which people experience sudden but not painful jerking of the leg while falling to sleep. Ambulant Able to provide informed consent
Exclusion criteria
Conditions known to cause cramps (neuromuscular or neurological disease, pregnancy; and haemodialysis). People diagnosed with diabetes, as diabetes commonly impairs nerve function Lower limb amputation except for digit amputation Lower back pain that lasted for longer than a day in the last 3 months Sciatica Hip or knee replacements in the last 6 months Non-skin lower limb malignancy Current lower limb soft tissue or bone infection Current lower limb fracture Unable to perform stretches of the lower limbs while holding a stretching towel with their upper limbs. Unable to write, read or comprehend English Morbid obesity (BMI > 40) Unwilling or unavailable to complete a 6 week stretching program, record cramps in a daily diary for 8 weeks (6 week trial period plus 2 weeks prior to trial), or attend 3 face-to-face appointments. People directed by a medical doctor to rest in bed or have low levels of activity.
Outcome results
None listed