Feasibility study to evaluate the clinical and cost effectiveness of foot orthoses in the management of plantar heel pain

ISRCTN ISRCTN73264439
DOI https://doi.org/10.1186/ISRCTN73264439
Secondary identifying numbers RRC300/SG
Submission date
18/12/2002
Registration date
18/12/2002
Last edited
09/10/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Keith Rome
Scientific

University of Teesside
School of Health and Social Care
Middlesbrough
TS1 3BA
United Kingdom

Phone +44 (0)1642 384977
Email K.Rome@tees.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPlantar heel pain
InterventionTwo types of foot orthoses (based on costs and function) were measured at baseline, 4 and 8 weeks using general (EQ5D), specific (Foot Health Status Questionnaire) outcome measures together with an economic questionnaire
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2001
Completion date01/01/2002

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants48
Key inclusion criteria48 patients clinically diagnosed with plantar heel pain. The inclusion criteria included the following:
1. Unilateral plantar heel pain of at least 2-months duration
2. A history of night-time or early morning pain, which decreases after walking, and/or increases after exercise or prolonged periods of standing
3. Heel pain severe enough to either cause a reduction in physical activity, a visit to a health professional, or the use of medication
4. Good general health
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2001
Date of final enrolment01/01/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Teesside
Middlesbrough
TS1 3BA
United Kingdom

Sponsor information

North Tyneside AHA Trust Research Unit (UK)
Hospital/treatment centre

North Tyneside General Hospital
Research Support Unit
Rake Lane
North Shields
NE29 8NH
England
United Kingdom

Funders

Funder type

Government

Department of Health (UK) - Directorate of Health & Social Care

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 01/05/2004 Yes No