Clinical trial of insoles for heel pain
| ISRCTN | ISRCTN47272667 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47272667 |
| Secondary identifying numbers | CT222 |
- Submission date
- 23/04/2008
- Registration date
- 31/07/2008
- Last edited
- 06/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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 Christopher Nester
Scientific
Scientific
Director
Centre for Rehabilitation & Human Performance Research
Brian Blatchford Building
University of Salford
Salford
M6 6PU
United Kingdom
| Phone | +44 (0)161 295 2275 |
|---|---|
| c.j.nester@salford.ac.uk |
Study information
| Study design | Randomised, single-blinded (subjects blinded), single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomized controlled trial to evaluate the effectiveness of insoles to treat plantar heel pain |
| Study acronym | HELP Trial |
| Study objectives | 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(s) | Ethics Committee, University of Salford, 23/03/2008, ref: 07/054 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 28/03/2008 |
| Completion date | 31/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 28/03/2008 |
| Date of final enrolment | 31/07/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Director
Salford
M6 6PU
United Kingdom
M6 6PU
United Kingdom
Sponsor information
SSL International (UK)
Industry
Industry
SSL International Plc
Venus, 1 Old Park Lane
Trafford Park
Urmston
Manchester
M41 7HA
United Kingdom
| Website | http://www.ssl-international.com |
|---|---|
"ROR" |
https://ror.org/01g87hr29 |
Funders
Funder type
Industry
SSL International Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
06/05/2016: No publications found, verifying study status with principal investigator.
