Contact information
Type
Scientific
Primary contact
Dr Richard Coppin
ORCID ID
Contact details
Research Office
The Surgery
Station Road
Overton
Basingstoke
RG25 3DZ
United Kingdom
+44 (0)1256 770600
overtonsurgery@dial.pipex.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SPGS787
Study information
Scientific title
Acronym
MONC
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Other symptoms and general pathology
Intervention
1. Stretching exercises
2. Non-stretching exercises and continuation of quinine treatment
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Diary of incidence
2. Frequency
3. Duration and severity of leg cramps
4. Subsequent GP attendance
5. Quinine and analgesic prescriptions
Secondary outcome measures
Not provided at time of registration
Overall trial start date
31/12/1998
Overall trial end date
31/12/2002
Reason abandoned
Eligibility
Participant inclusion criteria
191 patients from general practices aged 60 and over being prescribed quinine
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
191
Participant 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
Recruitment start date
31/12/1998
Recruitment end date
31/12/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Research Office
Basingstoke
RG25 3DZ
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South East (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15808033
Publication citations
-
Results
Coppin RJ, Wicke DM, Little PS, Managing nocturnal leg cramps--calf-stretching exercises and cessation of quinine treatment: a factorial randomised controlled trial., Br J Gen Pract, 2005, 55, 512, 186-191.