Condition category
Musculoskeletal Diseases
Date applied
23/04/2008
Date assigned
31/07/2008
Last edited
06/05/2016
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 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

http://www.ssl-international.com

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

Publication citations

Additional files

Editorial Notes

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