Condition category
Signs and Symptoms
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
12/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes