Are regular calf-stretching exercises effective in the management of nocturnal leg cramps? A controlled trial

ISRCTN	ISRCTN26051665
DOI	https://doi.org/10.1186/ISRCTN26051665
Protocol serial number	SPGS787
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive South East (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Richard Coppin
Scientific

Research Office
The Surgery
Station Road
Overton
Basingstoke
RG25 3DZ
United Kingdom

Phone	+44 (0)1256 770600
Email	overtonsurgery@dial.pipex.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	MONC
Study objectives	Are regular calf-stretching exercises effective in the management of nocturnal leg cramps? Nocturnal leg cramps are painful muscle spasms which commonly disrupt sleep. Their cause is unclear and they are frequently treated with quinine which is potentially toxic and costly to the NHS. In 1979 a small, uncontrolled trial suggested that a simple programme of leg muscle stretching exercises could prevent nocturnal leg cramps. This has been widely cited but no attempt seems to have been made to confirm or refute its conclusions. We intend to establish whether such exercises are effective, feasible and whether they reduce quinine use. To determine whether regular exercises are effective and feasible in the treatment of leg cramps.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Other symptoms and general pathology
Intervention	1. Stretching exercises 2. Non-stretching exercises and continuation of quinine treatment
Intervention type	Other
Primary outcome measure(s)	1. Diary of incidence 2. Frequency 3. Duration and severity of leg cramps 4. Subsequent GP attendance 5. Quinine and analgesic prescriptions
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2002

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	191
Key inclusion criteria	191 patients from general practices aged 60 and over being prescribed quinine
Key exclusion criteria	1. Previously taught cramp-preventing exercises 2. Unable to undertake exercises 3. Other conditions causing leg pain 4. Unable to report symptoms reliably
Date of first enrolment	31/12/1998
Date of final enrolment	31/12/2002

Research Office

Basingstoke
RG25 3DZ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2005		Yes	No