Clinical trial of insoles for heel pain

ISRCTN	ISRCTN47272667
DOI	https://doi.org/10.1186/ISRCTN47272667
Protocol serial number	CT222
Sponsor	SSL International (UK)
Funder	SSL International Ltd (UK)

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

Director
Centre for Rehabilitation & Human Performance Research
Brian Blatchford Building
University of Salford
Salford
M6 6PU
United Kingdom

Phone	+44 (0)161 295 2275
Email	c.j.nester@salford.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised, single-blinded (subjects blinded), single-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	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)
Completion date	31/07/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Director

Salford
M6 6PU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

06/05/2016: No publications found, verifying study status with principal investigator.