The effectiveness of manipulation therapy on joint mobility in the diabetic foot

ISRCTN ISRCTN76265234
DOI https://doi.org/10.1186/ISRCTN76265234
Secondary identifying numbers N0226114890
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
19/07/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr E Van Ross
Scientific

Disablement Services Centre
South Manchester University Hospitals NHS Trust
Withington Hospital
Nell Lane
Manchester
M20 2LR
United Kingdom

Phone +44 (0)161 613 7257
Email Ernest.Vanross@smuht.nwest.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleThe effectiveness of manipulation therapy on joint mobility in the diabetic foot
Study objectivesTo investigate the effectiveness of manipulation therapy in improving joint mobility in the diabetic foot; to determine the range of motion at the first metatarso-phalangeal joint and ankle joint before and after manipulation therapy; to determine plantar foot pressures before and after manipulation therapy.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNutritional, metabolic and endocrine diseases: Diabetic foot ulcer
InterventionPatients randomised to both the study and control groups will have the range of motion at the 1st metatarso-phalangeal and ankle joint measured.
The study group will then have the manipulation therapy.
In the control group, patients will have joint mobility and foot pressure measurements at 6 weeks apart, with option for manipulation therapy after completion of the study.
Intervention typeOther
Primary outcome measureChange in joint mobility at first metatarso-phalangeal and ankle joint after manipulation treatment.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/2003
Completion date01/04/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants12
Key inclusion criteria12 patients (attending the MFH, MDC, DSC and community podiatry clinics) with a positive prayer sign, neuropathy disability score of >6, presence of at least one foot pulse.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/04/2003
Date of final enrolment01/04/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

South Manchester University Hospitals NHS Trust
Manchester
M20 2LR
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

South Manchester University Hospitals NHS Trust (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

Editorial Notes

19/07/2017: No publications found in PubMed, verifying study status with principal investigator.