Contact information
Type
Scientific
Primary contact
Dr Keith Rome
ORCID ID
Contact details
University of Teesside
School of Health and Social Care
Middlesbrough
TS1 3BA
United Kingdom
+44 (0)1642 384977
K.Rome@tees.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RRC300/SG
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
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
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Plantar heel pain
Intervention
Two 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 type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2001
Overall trial end date
01/01/2002
Reason abandoned
Eligibility
Participant inclusion criteria
48 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
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
48
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2001
Recruitment end date
01/01/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Teesside
Middlesbrough
TS1 3BA
United Kingdom
Funders
Funder type
Government
Funder name
Department of Health (UK) - Directorate of Health & Social Care
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
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=15153583
Publication citations
-
Results
Rome K, Gray J, Stewart F, Hannant SC, Callaghan D, Hubble J, Evaluating the clinical effectiveness and cost-effectiveness of foot orthoses in the treatment of plantar heel pain: a feasibility study., J Am Podiatr Med Assoc, 94, 3, 229-238.