Heel Pain SyndromeNCT04380285
Treating Heel Pain in Adults: A Randomized Clinical Trial of Hard Versus Soft Orthotics
A study testing Custom heel pads and modified soft molded orthotics and Custom hard orthotic in people with Heel Pain Syndrome, run by Deborah Seligman, MSc., B.Sc.O.T..
Trial summary
Objectives: This study compared the effectiveness of soft versus hard orthotics in treating heel pain and plantar fasciitis in adults. It also compared the level of function after orthotic use, cost and number of visits for orthotics and explored if age was a factor in orthotic effectiveness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heel Pain Syndrome
- What is being tested?
- Custom heel pads and modified soft molded orthotics and Custom hard orthotic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- sample of convenience from the hospital and private clinic. The participants had heel pain associated with plantar fasciitis. Participants could describe and report changes in their pain
Who cannot join
- Those excluded were non-ambulatory (unable to walk greater than 25 meters) orchid spasticity due to a neurological disorder. Others excluded were non-communicative, had cognitive impairment or were unable to complete a questionnaire.
About this study
Official title: Treating Heel Pain Associated With Plantar Fasciitis in Adults: A Randomized Clinical Trial of Hard Versus Modified Soft Custom Orthotics and Heel Pads
Objectives: This study compared the effectiveness of soft versus hard orthotics in treating heel pain and plantar fasciitis in adults. It also compared the level of function after orthotic use, cost and number of visits for orthotics and explored if age was a factor in orthotic effectiveness.
Read the detailed description
Design: This randomized clinical trial included 44 adults (18+) with heel pain and plantar fasciitis. Participants received hard or soft customized orthotics and rated their pain intensity, pain interference and function, pre and post orthotic use. Scores were analyzed with repeated measures ANOVA. Analysis of age used repeated measures ANOVA. Costs were compared using t-test and number of visits was compared using Wilcoxon Rank Sum.
- Conditions
- Heel Pain Syndrome
- Being tested
- Custom heel pads and modified soft molded orthotics, Custom hard orthotic
- Keywords
- Foot, Heel Pain, Plantar Fasciitis, Orthotic Devices
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom heel pads and modified soft molded orthoticsDevice
Custom hard orthoticDevice
| Study group | Role | What they receive |
|---|---|---|
| Group 1. Custom heel pads and modified soft molded orthotics | Active comparator | Modified soft custom orthotics supported in the medial longitudinal arches and medial shock absorbing heel pads with customized cutout at the point corresponding to the heel pain Receives: Device: Custom heel pads and modified soft molded orthotics |
| Group 2. Custom hard orthotics | Active comparator | Custom hard orthotics made from a positive mold of a foot in neutral position, with arch support and medial heel postings. Receives: Device: Custom hard orthotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory: a sub-scale from this measurement tool measuring pain intensity. Change in pain intensity is being assessed using this measurement tool pre and post treatment.
Measures pain intensity on a numeric rating scale with anchors of 'no pain' (0) to 'pain as bad as you can imagine' (10)
Measured: This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.
Secondary outcomes (2)
Brief Pain Inventory: a sub-scale from this measurement tool measuring pain interference with activity and level of function. Change in pain interference is being assessed using this measurement tool pre and post treatment.
Pain interference was rated on the following items: general activity, walking, work, relations with other people, mood, sleep and enjoyment of life, using a numeric scale with anchors 'does not interfere (0) to 'completely interferes' (10)
Measured: This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.
Late Life Function and Disability Instrument (Late Life FDI): Function component. Change in function is being assessed using this measurement tool pre and post treatment.
It rates one's ability to do a wide variety of activities that involve basic upper and lower extremity function, such as reaching, standing and bending as well as higher levels of physical endurance such as walking and climbing stairs.It is a 32 item self-report questionnaire with five response categories and a score ranging from 32 to 160.
Measured: This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study startJan 2003
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heel Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design was a randomized clinical trial.The study was completed when the target number of recruitments was reached. Prior to randomization to treatment groups, patients were stratified by age (younger adults: 18 - 64 years and older adults: 65 years and older) in blocks of four to ensure that there were an equal number of participants receiving soft versus hard orthotics in each age group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deborah Seligman, MSc., B.Sc.O.T.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deborah Seligman, MSc., B.Sc.O.T., University of Toronto
- Investigators
- Aileen Davis, PhD,BScPT, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380285
- Sponsor's protocol ID
- #9964
- Status last verified
- May 2020
- First submitted
- 28 Apr 2020
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, measurement tools, interventions used.
Publications
Seligman DAR, Dawson D, Streiner DL, Seligman DJ, Davis A. Treating Heel Pain in Adults: A Randomized Controlled Trial of Hard vs Modified Soft Custom Orthotics and Heel Pads. Arch Phys Med Rehabil. 2021 Mar;102(3):363-370. doi: 10.1016/j.apmr.2020.10.124. Epub 2020 Nov 18.
PubMed 33217374
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Heel Pain Associated With Plantar Fasciitis in Adults: A Randomized Clinical Trial of Hard Versus Modified Soft Custom Orthotics and Heel Pads
- ClinicalTrials.gov ID
- NCT04380285
- Acronym / sponsor ID
- #9964
- Conditions
- Heel Pain Syndrome
- Keywords
- Foot, Heel Pain, Plantar Fasciitis, Orthotic Devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Deborah Seligman, MSc., B.Sc.O.T.University, hospital or other
- Study start
- Jan 2003 (actual)
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: This study compared the effectiveness of soft versus hard orthotics in treating heel pain and plantar fasciitis in adults. It also compared the level of function after orthotic use, cost and number of visits for orthotics and explored if age was a factor in orthotic effectiveness.
Detailed description
Design: This randomized clinical trial included 44 adults (18+) with heel pain and plantar fasciitis. Participants received hard or soft customized orthotics and rated their pain intensity, pain interference and function, pre and post orthotic use. Scores were analyzed with repeated measures ANOVA. Analysis of age used repeated measures ANOVA. Costs were compared using t-test and number of visits was compared using Wilcoxon Rank Sum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study design was a randomized clinical trial.The study was completed when the target number of recruitments was reached. Prior to randomization to treatment groups, patients were stratified by age (younger adults: 18 - 64 years and older adults: 65 years and older) in blocks of four to ensure that there were an equal number of participants receiving soft versus hard orthotics in each age group.
| Arm | Type | Receives |
|---|---|---|
| Group 1. Custom heel pads and modified soft molded orthotics | Active comparator | Device: Custom heel pads and modified soft molded orthoticsModified soft custom orthotics supported in the medial longitudinal arches and medial shock absorbing heel pads with customized cutout at the point corresponding to the heel pain |
| Group 2. Custom hard orthotics | Active comparator | Device: Custom hard orthoticCustom hard orthotics made from a positive mold of a foot in neutral position, with arch support and medial heel postings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- sample of convenience from the hospital and private clinic. The participants had heel pain associated with plantar fasciitis. Participants could describe and report changes in their pain
Key exclusion criteria (1 listed)
- Those excluded were non-ambulatory (unable to walk greater than 25 meters) orchid spasticity due to a neurological disorder. Others excluded were non-communicative, had cognitive impairment or were unable to complete a questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom heel pads and modified soft molded orthotics | Device | Group 1. Custom heel pads and modified soft molded orthotics |
| Custom hard orthotic | Device | Group 2. Custom hard orthotics |
Primary outcome
Brief Pain Inventory: a sub-scale from this measurement tool measuring pain intensity. Change in pain intensity is being assessed using this measurement tool pre and post treatment.
Time frame: This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.
Measures pain intensity on a numeric rating scale with anchors of 'no pain' (0) to 'pain as bad as you can imagine' (10)
2 secondary outcomes
Brief Pain Inventory: a sub-scale from this measurement tool measuring pain interference with activity and level of function. Change in pain interference is being assessed using this measurement tool pre and post treatment.
Time frame: This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.
Late Life Function and Disability Instrument (Late Life FDI): Function component. Change in function is being assessed using this measurement tool pre and post treatment.
Time frame: This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Derived from this study: PubMed 33217374Seligman DAR, Dawson D, Streiner DL, Seligman DJ, Davis A. Treating Heel Pain in Adults: A Randomized Controlled Trial of Hard vs Modified Soft Custom Orthotics and Heel Pads. Arch Phys Med Rehabil. 2021 Mar;102(3):363-370. doi: 10.1016/j.apmr.2020.10.124. Epub 2020 Nov 18.
- Individual participant dataSharing planned: Yes. Study protocol, measurement tools, interventions used.
Related trials for Heel Pain Syndrome
Not yet recruiting
Acupuncture for Heel Pain Syndrome
Heel Pain Syndrome
Recruiting
Individualized Rehabilitation for Osgood-Schlatter or Sever Pain in Youth Athletes
Osgood-Schlatter Disease, Sever's Disease
Not yet recruiting
Baxter's Nerve Pulsed Radiofrequency Versus Platelet-Rich Plasma Injection or Both Together as a Treatment Modality of Recalcitrant Plantar Fasciitis
Plantar Fasciitis, Heel Pain
Not yet recruiting
Effect of Kaltenborn vs Mulligan Mobilization With Intrinsic Foot Strengthening in Plantar Fasciitis
Plantar Fascitis, Heel Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aileen Davis, PhD,BScPT principal investigator
University of Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Custom heel pads and modified soft molded orthotics and Custom hard orthotic in people with Heel Pain Syndrome, run by Deborah Seligman, MSc., B.Sc.O.T..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory: a sub-scale from this measurement tool measuring pain intensity. Change in pain intensity is being assessed using this measurement tool pre and post treatment. (time frame: This questionnaire was administered on the initial visit and then 6 weeks after orthotics were provided.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04380285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.