Contact information
Type
Scientific
Primary contact
Dr Christopher Nester
ORCID ID
Contact details
Director
Centre for Rehabilitation & Human Performance Research
Brian Blatchford Building
University of Salford
Salford
M6 6PU
United Kingdom
+44 (0)161 295 2275
c.j.nester@salford.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CT222
Study information
Scientific title
A randomized controlled trial to evaluate the effectiveness of insoles to treat plantar heel pain
Acronym
HELP Trial
Study hypothesis
A functional insole and a silicon gel heel pad will each produce greater improvements in heel pain compared to a sham control group.
Ethics approval
Ethics Committee, University of Salford, 23/03/2008, ref: 07/054
Study design
Randomised, single-blinded (subjects blinded), single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Plantar heel pain
Intervention
The participants will be randomly allocated to the following three arms:
1. Intervention group 1: Orthaheel® regular. This is a 3/4 length insole with arch shape which is positioned under the heel and the middle of the foot. It is inserted into shoes and worn daily.
2. Intervention group 2: Orthaheel® gel heel pad. This is a silicon gel based insole which is positioned under the heel. It is inserted into shoes and worn daily.
3. Sham control group: Flat 3 mm soft insole with fabric cover
Subjects are blinded to their group allocation.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Foot pain
2. Foot health related function
Foot pain will be measured primarily using a 0-10 visual analogue scale. The Foot Health Status Questionnaire (FHSQ) will be used to provide categorical assessment of pain and foot health related function.
Primary timepoint of interest: 4 weeks
Secondary outcome measures
1. Use of insoles (in time)
2. Foot pain at 3, 6 and 12 months (see Primary outcome measures for details)
3. Foot health related function at 3, 6 and 12 months (see Primary outcome measures for details)
Overall trial start date
28/03/2008
Overall trial end date
31/07/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male or female participants between the ages of 18 and 65 years old
2. Participants with self-reported plantar heel pain with a minimum of 4 weeks duration
3. Self-reported plantar heel pain who score at least 40 mm on a 100 mm visual analogue scale (VAS) for pain
4. Participants with plantar heel pain in the 2 days prior to recruitment
5. Participants who agree to wear the insoles provided for at least 4 hours each day
6. Participants who give written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Participants reporting acute injury to the foot at the onset of the plantar heel pain
2. Participants with posterior or medial/lateral heel pain or any secondary pain elsewhere in the foot since the onset of plantar heel pain
3. Participants with significant musculo-skeletal disease diagnosed such as rheumatoid arthritis, hip, knee or back pain
4. Participants with sensory or motor function disease such as diabetes
5. Participants who are pregnant or breast-feeding
6. Participants who have received or self-administered treatment for the heel pain in the previous 4 weeks
7. Participants who have received corticosteroid injection therapy in the heel in the previous 3 months
8. Participants that were previously in this study
9. Participants that were in another study within the last 3 months
Recruitment start date
28/03/2008
Recruitment end date
31/07/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Director
Salford
M6 6PU
United Kingdom
Sponsor information
Organisation
SSL International (UK)
Sponsor details
SSL International Plc
Venus
1 Old Park Lane
Trafford Park
Urmston
Manchester
M41 7HA
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
SSL International Ltd (UK)
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