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
Secondary identifying numbers SPGS787
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
12/01/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific title
Study acronymMONC
Study objectivesAre 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) studiedOther symptoms and general pathology
Intervention1. Stretching exercises
2. Non-stretching exercises and continuation of quinine treatment
Intervention typeOther
Primary outcome measure1. Diary of incidence
2. Frequency
3. Duration and severity of leg cramps
4. Subsequent GP attendance
5. Quinine and analgesic prescriptions
Secondary outcome measuresNot provided at time of registration
Overall study start date31/12/1998
Completion date31/12/2002

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants191
Key inclusion criteria191 patients from general practices aged 60 and over being prescribed quinine
Key exclusion criteria1. 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 enrolment31/12/1998
Date of final enrolment31/12/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Research Office
Basingstoke
RG25 3DZ
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive South East (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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