Fasciitis, Plantar, ChronicNCT04461197
Efficacy of the Treatment of Plantar Orthoses With Extracorporeal Shock Wave Therapy in Plantar Fasciitis
A study testing customised foot orthoses and orthotic insole in people with Fasciitis, Plantar, Chronic, run by University of Seville at 1 site in Spain.
Trial summary
Plantar fasciitis is inflammation of plantar fascia. It arises from degeneration and chronic inflammation. Treatment of plantar fasciitis contains conservative methods like rest, body weight control, stretching exercise, non-steroidal anti-inflammatory drugs and arch supports. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fasciitis, Plantar, Chronic
- What is being tested?
- customised foot orthoses and orthotic insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jun 2019to 15 Jun 2020
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 - 65 years
- able to understand the explanations about the potential benefits and risks of participating in the study
- both genders
- diagnosis of chronic plantar fasciitis
- duration of symptoms equal or superior to 6 months at the time of enrollment
- Foot Posture Index ≥ +6 (pronated foot in one or both feet).
Who cannot join
- being younger than 18 years of age
- previous treatments with shock wave devices
- previous surgery on the painful heel; history of calcaneus fracture
- any inflammation at the level of the ankle
- infection in the treated area
- patients with diabetes mellitus or cardiac or respiratory disease
Show all 17Show fewer
- osteomyelitis
- patients on anticoagulant drugs
- pregnancy
- patients on immunosuppressive therapy
- rheumatoid arthritis or history of rheumatic disease
- neurological deficits
- malignant disease with or without metastases
- significant liver function abnormalities
- neurological or vascular insufficiency in the painful heel; fasciotomy or heel spur surgery
- discrepancy in the length of the foot > 5 mm; previous back of foot surgery
- patients treated with rigid plantar supports
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Therapeutic Effects of Adjunctive Treatment of Plantar Orthoses With Extracorporeal Shock Wave Therapy in Plantar Fasciitis: a Randomized Clinical Trial.
Plantar fasciitis is inflammation of plantar fascia. It arises from degeneration and chronic inflammation. Treatment of plantar fasciitis contains conservative methods like rest, body weight control, stretching exercise, non-steroidal anti-inflammatory drugs and arch supports. ESWT has commonly been used for the treatment of plantar fasciitis. The shock waves can be radial or focused. The aim of this study was to evaluate the effectiveness of the adjuvant use of plantar orthoses in the process of plantar fasciitis when extracorporeal shock waves are applied. The hypothesis porposed was that the use of extracorporeal shock waves together with the use of custom foot orthotics improves the symptoms produced by plantar fasciitis. This study is planned as double-blind, randomized controlled trial. Participants are randomly allocated to two groups: the ESWT group and the custom foot orthotics and ESWT group. Radial ESWT will be applied in this study.
The people receiving the therapy and the people assessing the outcomes are blinded . Both group will recieve ESWT one session per week for three weeks. Each session will last for 2-5 minutes. The primary outcome measure of this study is change in heel pain of affected side assessed using Visual Analog Scale. The secondary outcome measure is Roles y Maudsley scores. The primary endpoint of this study is to determine a decrease in pain score according to Visual Analog Scale.
- Conditions
- Fasciitis, Plantar, Chronic
- Being tested
- customised foot orthoses, orthotic insole
- Keywords
- Fasciitis, Plantar, Foot Orthoses, High-Energy Shock Waves
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
customised foot orthosesDevice
The foot orthoses for group A were custom made using phenolic foam molds of the feet. Separated molds were made of both feet for all the participants. . The insole was made based on a positive mold of plaster with 45 Shore cork materials with horizontal thrusts just proximal to the metatarsal heads, with the intention of correcting the pathological subtalar pronation, with a 3mm bilateral raising of the heel and a bilateral latex metatarsal bar.
orthotic insoleDevice
For group B, a flat insole of polyester resin was made, fitting it to the foot's size.
| Study group | Role | What they receive |
|---|---|---|
| ESWT + orthotic insole | Experimental | (shock waves + orthotic insole +Stretches of the posterior muscle chain) Receives: Device: customised foot orthoses |
| ESWT + flat insole | Placebo comparator | (shock waves + flat insole + Stretches of the posterior muscle chain) Receives: Device: orthotic insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale (VAS)
Heel pain intensity was referred to as 0-10, in which 0= no pain at all and 10= the worst pain possible
Measured: Baseline
Secondary outcomes (1)
Roles-Maudsley (RM) scores
This is a self-administered scale of functional valuation which classifies the patients into 4 categories
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start20 Jun 2019
- Primary completion15 May 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasciitis, Plantar, ChronicStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MANUEL PABON CARRASCO, University of Seville
- Investigators
- Ana J Perez, Dra., Study director, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461197
- Sponsor's protocol ID
- CRESEUE-Foot 2
- Status last verified
- Apr 2021
- First submitted
- 26 Jun 2020
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Therapeutic Effects of Adjunctive Treatment of Plantar Orthoses With Extracorporeal Shock Wave Therapy in Plantar Fasciitis: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04461197
- Acronym / sponsor ID
- CRESEUE-Foot 2
- Conditions
- Fasciitis, Plantar, Chronic
- Keywords
- Fasciitis, Plantar, Foot Orthoses, High-Energy Shock Waves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 8 Jul 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.
Plantar fasciitis is inflammation of plantar fascia. It arises from degeneration and chronic inflammation. Treatment of plantar fasciitis contains conservative methods like rest, body weight control, stretching exercise, non-steroidal anti-inflammatory drugs and arch supports. ESWT has commonly been used for the treatment of plantar fasciitis. The shock waves can be radial or focused. The aim of this study was to evaluate the effectiveness of the adjuvant use of plantar orthoses in the process of plantar fasciitis when extracorporeal shock waves are applied. The hypothesis porposed was that the use of extracorporeal shock waves together with the use of custom foot orthotics improves the symptoms produced by plantar fasciitis. This study is planned as double-blind, randomized controlled trial. Participants are randomly allocated to two groups: the ESWT group and the custom foot orthotics and ESWT group. Radial ESWT will be applied in this study.
The people receiving the therapy and the people assessing the outcomes are blinded . Both group will recieve ESWT one session per week for three weeks. Each session will last for 2-5 minutes. The primary outcome measure of this study is change in heel pain of affected side assessed using Visual Analog Scale. The secondary outcome measure is Roles y Maudsley scores. The primary endpoint of this study is to determine a decrease in pain score according to Visual Analog Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWT + orthotic insole | Experimental | Device: customised foot orthoses(shock waves + orthotic insole +Stretches of the posterior muscle chain) |
| ESWT + flat insole | Placebo comparator | Device: orthotic insole(shock waves + flat insole + Stretches of the posterior muscle chain) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 - 65 years
- able to understand the explanations about the potential benefits and risks of participating in the study
- both genders
- diagnosis of chronic plantar fasciitis
- duration of symptoms equal or superior to 6 months at the time of enrollment
Key exclusion criteria (17 listed)
- being younger than 18 years of age
- previous treatments with shock wave devices
- previous surgery on the painful heel; history of calcaneus fracture
- any inflammation at the level of the ankle
- infection in the treated area
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 |
|---|---|---|
| customised foot orthosesThe foot orthoses for group A were custom made using phenolic foam molds of the feet. Separated molds were made of both feet for all the participants. . The insole was made based on a positive mold of plaster with 45 Shore cork materials with horizontal thrusts just proximal to the metatarsal heads, with the intention of correcting the pathological subtalar pronation, with a 3mm bilateral raising of the heel and a bilateral latex metatarsal bar. | Device | ESWT + orthotic insole |
| orthotic insoleFor group B, a flat insole of polyester resin was made, fitting it to the foot's size. | Device | ESWT + flat insole |
Primary outcome
visual analog scale (VAS)
Time frame: Baseline
Heel pain intensity was referred to as 0-10, in which 0= no pain at all and 10= the worst pain possible
1 secondary outcome
Roles-Maudsley (RM) scores
Time frame: Baseline
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 14 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Ana J Perez, Dra. study director
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing customised foot orthoses and orthotic insole in people with Fasciitis, Plantar, Chronic, run by University of Seville at 1 site in Spain.
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 6 inclusion and 17 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 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
visual analog scale (VAS) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2021.