Condition category
Musculoskeletal Diseases
Date applied
18/12/2002
Date assigned
18/12/2002
Last edited
09/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

North Tyneside AHA Trust Research Unit (UK)

Sponsor details

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

Sponsor type

Government

Website

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

  1. 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.

Additional files

Editorial Notes