Fasciitis, Plantar, ChronicSOFTNCT03854682
Surgical or Non-surgical Treatment of Plantar Fasciitis
A study testing Radiofrequency microtenotomy and Strength training in people with Fasciitis, Plantar, Chronic, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Plantar fasciitis (PF) is one of the most common causes of heel pain in 40-60 year old people. Approximately 10% of the population is affected by the disorder and the PF prevalence is 3.6-7.0%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fasciitis, Plantar, Chronic
- What is being tested?
- Radiofrequency microtenotomy and Strength training
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2020to 1 Jun 2025
- 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
- VAS pain score > 30 within last 7 days
- Plantar heel pain> 7 months
- Palpation soreness fascia plantaris at heel
- Plantar heel pain during first steps (First-step sign)
- Read and understand Danish
Who cannot join
- Systemic diseases or neuropathy
- Diabetes
- Pregnant
- Previous heel surgery on same foot
- Cortisone injections within past 3 months
- Bilateral symptom onset within past 7 days
Show all 11Show fewer
- Signs of tarsal tunnel
- Facia plantaris thickness of less than 4 mm
- Performed message / head recovery / stretching within the past month
- Any treatment for plantar pain within the past 3 months
- Other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical or Non-surgical Treatment of Plantar Fasciitis - A Randomized Clinical Trial
Plantar fasciitis (PF) is one of the most common causes of heel pain in 40-60 year old people. Approximately 10% of the population is affected by the disorder and the PF prevalence is 3.6-7.0%. The risk factors include decreased ankle dorsiflexion, overweight (BMI> 27), pronated foot position, and prolonged work and activity-related weight bearing. The condition affects both active and less active people.
The typical symptoms are pain around the attachment of the foot's tendon mirror (fascia plantaris), especially the medial part. The pain is well defined and occurs during weight bearing activities or during the first steps after rest. The walking pattern is changed to relieve pain. Ultrasound scan is used to confirm the diagnosis (thickened tendon mirror> 4 mm). The condition is described as inflammatory, but the relationship between the initial inflammatory condition and the chronic tendon mirror overload injury (fasciopathy) is unknown and marked by degenerative changes.
Read more
Although the majority of people improve within 1-2 years, the long-term prognosis is unknown. People with symptoms lasting > 7 months have poor prognosis and should be offered other treatment. Non-surgical treatment is often first line of treatment followed by surgical treatment.
In this clinical trial investigators compare pain levels (FHSQ-DK) in people, who receive surgical treatment (radiofrequency microtenotomy, shoe inserts and patient education) and people who receive non-surgical treatment (strength training, shoe inserts and patient education) with a primary end-point at 6 months. The hypothesis is that surgical treatment is better than non-surgical treatment measured by FHSQ-DK (pain)
Read the detailed description
To be completed later
- Conditions
- Fasciitis, Plantar, Chronic
- Being tested
- Radiofrequency microtenotomy, Strength training
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency microtenotomyProcedure or surgery
A longitudinal incision of about 3 cm will be made over the most tender part of the foot taking care to avoid the weight bearing part of the sole, and the tissues dissected down to the affected plantar fascia. After initiating sterile isotonic saline flow of 1 drop every 1-2 s from a line connected to the RF system, the TOPAZ tip will be placed onto the fascia and the micro debridements carried out in a grid like pattern on and throughout the symptomatic fascia area. After debridement, the wound will be irrigated with copious amounts of normal saline solution and closed in layers. A local anaesthetic will be injected into the skin and subcutaneous tissues around the wound and standard wound dressings will be applied
Strength trainingBehavioural
Also called Resistance training
Non-surgical treatment consists of one-legged heel lift to primarily activate the windlass effect and increase the mechanical stress on the tendon. The exercise is performed on a step, a thick book or the like, so the heel movement finishes below the horizontal level. The exercise is performed every other day with as many sets as possible and as heavy as possible, but not heavier than eight repetitions can be performed per. set. The load progressed from two to one leg +/- backpack. The exercise is performed as 3 s/2 s / 3 s concentric, isometric and eccentric respectively followed by 2 min rest. Patients continue to exercise 4 weeks after patient acceptable symptom state (PASS) has been achieved
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Experimental | Radiofrequency microtenotomy (RF): A longitudinal incision of about 3 cm will be made over the most tender part of the foot taking care to avoid the weight bearing part of the sole, and the tissues dissected down to the affected plantar fascia. After initiating sterile isotonic saline flow of 1 drop every 1-2 s from a line connected to the RF system, the TOPAZ tip will be placed onto the fascia and the micro debridements carried out in a grid like pattern on and throughout the symptomatic fascia area. After debridement, the wound will be irrigated with copious amounts of normal saline solution and closed in layers. A local anaesthetic will be injected into the skin and subcutaneous tissues around the wound and standard wound dressings will be applied Receives: Procedure: Radiofrequency microtenotomy |
| Non-surgical | Active comparator | Strength training: Consists of one-legged heel lift to primarily activate the windlass effect and increase the mechanical stress on the tendon. The exercise is performed on a step, a thick book or the like, so the heel movement finishes below the horizontal level. The exercise is performed every other day with as many sets as possible and as heavy as possible, but not heavier than eight repetitions can be performed per. set. The load progressed from two to one leg +/- backpack. The exercise is performed as 3 s/2 s / 3 s concentric, isometric and eccentric respectively followed by 2 min rest. Patients continue to exercise 4 weeks after patient acceptable symptom state (PASS) has been achieved Receives: Behavioral: Strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Foot Health Status Questionnaire (FHSQ)
Subdomain foot pain score range 0-100, low values represent worse conditions
Measured: Change from baseline at 6 months
Secondary outcomes (4)
The Foot Health Status Questionnaire (FHSQ)
Subdomains (foot related function, footwear and general foot health perception). Subdomain scores range from 0-100, low scores represent worse conditions
Measured: Change from baseline at 6 months
Visual Analog Scale (VAS)
Pain and scores range from 0-100, low values represent worse conditions
Measured: Change from baseline at 6 months
Global Percieved Effect (GPE)
A questionnaire using a 7-point likert scale to asses change in symptoms. The scores are categorized into (1-2 = deterioration of symptoms, 3-5 = Neutral, 6-7 improvement of symptoms).
Measured: 1,3,6,12 months post-intervention
Physical Activity Questionnaire (IPAQ)
Participation in sports and activities of daily living measured as MET-minutes/day or MET-minutes/week. Low MET-scores indicate limited activity. MET = metabolic equivalent of task
Measured: Change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 May 2020
- Primary completion1 Jun 2024
- Study completion1 Jun 2025
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 Fasciitis, Plantar, ChronicStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- A prospective, blinded, parallel-group trial with balanced randomization \[1:1\], in accordance with CONSORT
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carsten Jensen, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854682
- Sponsor's protocol ID
- 67030
- Acronym
- SOFT
- Status last verified
- Apr 2026
- First submitted
- 8 Feb 2019
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moller S, Riel H, Wester J, Simony A, Viberg B, Jensen C. Surgical or non-surgical treatment of plantar fasciopathy (SOFT): study protocol for a randomized controlled trial. Trials. 2022 Oct 4;23(1):845. doi: 10.1186/s13063-022-06785-w.
PubMed 36195936
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical or Non-surgical Treatment of Plantar Fasciitis - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03854682
- Acronym / sponsor ID
- SOFT / 67030
- Conditions
- Fasciitis, Plantar, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 26 Feb 2019 (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 (PF) is one of the most common causes of heel pain in 40-60 year old people. Approximately 10% of the population is affected by the disorder and the PF prevalence is 3.6-7.0%. The risk factors include decreased ankle dorsiflexion, overweight (BMI> 27), pronated foot position, and prolonged work and activity-related weight bearing. The condition affects both active and less active people.
The typical symptoms are pain around the attachment of the foot's tendon mirror (fascia plantaris), especially the medial part. The pain is well defined and occurs during weight bearing activities or during the first steps after rest. The walking pattern is changed to relieve pain. Ultrasound scan is used to confirm the diagnosis (thickened tendon mirror> 4 mm). The condition is described as inflammatory, but the relationship between the initial inflammatory condition and the chronic tendon mirror overload injury (fasciopathy) is unknown and marked by degenerative changes.
Although the majority of people improve within 1-2 years, the long-term prognosis is unknown. People with symptoms lasting > 7 months have poor prognosis and should be offered other treatment. Non-surgical treatment is often first line of treatment followed by surgical treatment.
In this clinical trial investigators compare pain levels (FHSQ-DK) in people, who receive surgical treatment (radiofrequency microtenotomy, shoe inserts and patient education) and people who receive non-surgical treatment (strength training, shoe inserts and patient education) with a primary end-point at 6 months. The hypothesis is that surgical treatment is better than non-surgical treatment measured by FHSQ-DK (pain)
Detailed description
To be completed later
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, blinded, parallel-group trial with balanced randomization [1:1], in accordance with CONSORT
| Arm | Type | Receives |
|---|---|---|
| Surgical | Experimental | Procedure: Radiofrequency microtenotomyRadiofrequency microtenotomy (RF): A longitudinal incision of about 3 cm will be made over the most tender part of the foot taking care to avoid the weight bearing part of the sole, and the tissues dissected down to the affected plantar fascia. After initiating sterile isotonic saline flow of 1 drop every 1-2 s from a line connected to the RF system, the TOPAZ tip will be placed onto the fascia and the micro debridements carried out in a grid like pattern on and throughout the symptomatic fascia area. After debridement, the wound will be irrigated with copious amounts of normal saline solution and closed in layers. A local anaesthetic will be injected into the skin and subcutaneous tissues around the wound and standard wound dressings will be applied |
| Non-surgical | Active comparator | Behavioral: Strength trainingStrength training: Consists of one-legged heel lift to primarily activate the windlass effect and increase the mechanical stress on the tendon. The exercise is performed on a step, a thick book or the like, so the heel movement finishes below the horizontal level. The exercise is performed every other day with as many sets as possible and as heavy as possible, but not heavier than eight repetitions can be performed per. set. The load progressed from two to one leg +/- backpack. The exercise is performed as 3 s/2 s / 3 s concentric, isometric and eccentric respectively followed by 2 min rest. Patients continue to exercise 4 weeks after patient acceptable symptom state (PASS) has been achieved |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- VAS pain score > 30 within last 7 days
- Plantar heel pain> 7 months
- Palpation soreness fascia plantaris at heel
- Plantar heel pain during first steps (First-step sign)
- Read and understand Danish
Key exclusion criteria (11 listed)
- Systemic diseases or neuropathy
- Diabetes
- Pregnant
- Previous heel surgery on same foot
- Cortisone injections within past 3 months
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 |
|---|---|---|
| Radiofrequency microtenotomyA longitudinal incision of about 3 cm will be made over the most tender part of the foot taking care to avoid the weight bearing part of the sole, and the tissues dissected down to the affected plantar fascia. After initiating sterile isotonic saline flow of 1 drop every 1-2 s from a line connected to the RF system, the TOPAZ tip will be placed onto the fascia and the micro debridements carried out in a grid like pattern on and throughout the symptomatic fascia area. After debridement, the wound will be irrigated with copious amounts of normal saline solution and closed in layers. A local anaesthetic will be injected into the skin and subcutaneous tissues around the wound and standard wound dressings will be applied | Procedure or surgery | Surgical |
| Strength trainingAlso: Resistance trainingNon-surgical treatment consists of one-legged heel lift to primarily activate the windlass effect and increase the mechanical stress on the tendon. The exercise is performed on a step, a thick book or the like, so the heel movement finishes below the horizontal level. The exercise is performed every other day with as many sets as possible and as heavy as possible, but not heavier than eight repetitions can be performed per. set. The load progressed from two to one leg +/- backpack. The exercise is performed as 3 s/2 s / 3 s concentric, isometric and eccentric respectively followed by 2 min rest. Patients continue to exercise 4 weeks after patient acceptable symptom state (PASS) has been achieved | Behavioural | Non-surgical |
Primary outcome
Change in the Foot Health Status Questionnaire (FHSQ)
Time frame: Change from baseline at 6 months
Subdomain foot pain score range 0-100, low values represent worse conditions
4 secondary outcomes
The Foot Health Status Questionnaire (FHSQ)
Time frame: Change from baseline at 6 months
Visual Analog Scale (VAS)
Time frame: Change from baseline at 6 months
Global Percieved Effect (GPE)
Time frame: 1,3,6,12 months post-intervention
Physical Activity Questionnaire (IPAQ)
Time frame: Change from baseline at 6 months
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 5 May 2026.
- Derived from this study: PubMed 36195936Moller S, Riel H, Wester J, Simony A, Viberg B, Jensen C. Surgical or non-surgical treatment of plantar fasciopathy (SOFT): study protocol for a randomized controlled trial. Trials. 2022 Oct 4;23(1):845. doi: 10.1186/s13063-022-06785-w.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency microtenotomy and Strength training in people with Fasciitis, Plantar, Chronic, run by University of Southern Denmark at 1 site in Denmark.
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 5 inclusion and 11 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 5 May 2026. 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 Denmark. 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. 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?
Change in the Foot Health Status Questionnaire (FHSQ) (time frame: Change from baseline at 6 months). 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 NCT03854682, 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 5 May 2026.