The effectiveness of manipulation therapy on joint mobility in the diabetic foot
| ISRCTN | ISRCTN76265234 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76265234 |
| Protocol serial number | N0226114890 |
| Sponsor | Department of Health (UK) |
| Funder | South Manchester University Hospitals NHS Trust (UK) |
- 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
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 |
|---|---|
| Ernest.Vanross@smuht.nwest.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The effectiveness of manipulation therapy on joint mobility in the diabetic foot |
| Study objectives | To 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) studied | Nutritional, metabolic and endocrine diseases: Diabetic foot ulcer |
| Intervention | Patients 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 type | Other |
| Primary outcome measure(s) |
Change in joint mobility at first metatarso-phalangeal and ankle joint after manipulation treatment. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 12 |
| Key inclusion criteria | 12 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 criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 01/04/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
South Manchester University Hospitals NHS Trust
Manchester
M20 2LR
United Kingdom
M20 2LR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
19/07/2017: No publications found in PubMed, verifying study status with principal investigator.
