Are regular calf-stretching exercises effective in the management of nocturnal leg cramps? A controlled trial
ISRCTN | ISRCTN26051665 |
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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
Scientific
Research Office
The Surgery
Station Road
Overton
Basingstoke
RG25 3DZ
United Kingdom
Phone | +44 (0)1256 770600 |
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overtonsurgery@dial.pipex.com |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | GP practice |
Study type | Treatment |
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 | 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 study start date | 31/12/1998 |
Completion date | 31/12/2002 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Research Office
Basingstoke
RG25 3DZ
United Kingdom
RG25 3DZ
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |