Plantar FascitisNCT03472989
Plantar Fasciopathy and the Effectiveness of Radial Extracorporeal Shockwave Therapy, Physical Training or Usual Care
A study testing Radial extracorporeal shock wave and Standardized high-load exercise program in people with Plantar Fascitis, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to evaluate whether radial extracorporeal shockwave therapy (rESWT), sham- rESWT or standardised exercise program is more effective on change in heel pain than usual care in the treatment of plantar fasciopathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Radial extracorporeal shock wave and Standardized high-load exercise program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 21 Mar 2018to 22 Feb 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain with duration > 3 months localized in the proximal insertion of the plantar fascia on the medial calcaneal tuberosity.
- Only patients with reported pain NRS 3 or more at activity at baseline, will be included in the trial.
- Tenderness to palpation corresponding to the painful area.
- Be residents of Norway, understand oral and written Norwegian.
Who cannot join
- Treatment with radial extracorporeal shock wave therapy the last 3 months.
- Spondylarthropathy or rheumatoid arthritis.
- Plantar fibromatosis.
- Tarsal tunnel syndrome.
- Polyneuropathy.
- Previous surgery with remaining osteosynthesis material in the foot or ankle.
- Contraindications for shock wave therapy ( use of anticoagulant drugs, pregnancy, bleeding disorders, epilepsy or pacemaker)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Radial Extracorporeal Shockwave Therapy (rESWT), Sham- rESWT, Standardised Exercise Program or Usual Care for Patients With Plantar Fasciopathy. Study Protocol for a Double-blind, Randomised Sham- Controlled Trial
The purpose of this study is to evaluate whether radial extracorporeal shockwave therapy (rESWT), sham- rESWT or standardised exercise program is more effective on change in heel pain than usual care in the treatment of plantar fasciopathy.
The null hypothesis is: There is no difference between rESWT, sham- rESWT or standardised exercise program on change in heel pain (primary outcome) and functioning (secondary outcomes) compared to usual care in the treatment of plantar fasciopathy at 6 months follow-up (and secondary outcomes at the 12 months follow-up).
Read more
Alternative hypothesis is:
H1: There is a difference between rESWT and usual care on change in heel pain (and secondary outcomes) at the 6 months follow-up (and secondary outcomes at the 12 months follow-up).
H2: There is a difference between sham-rESWT and usual care on change in heel pain (and secondary outcomes ) at 6 months follow-up (and secondary outcomes at the 12 months follow-up).
H3: There is a difference between standardized exercise program and usual care on change in heel pain (and secondary outcomes) at 6 months follow- up (and secondary outcomes at the 12 months follow-up).
Read the detailed description
Plantar fasciopathy is a common cause of plantar heel pain, with reported lifetime prevalence up to 10%. The choice of best practice in these patients is debated. Two randomised studies reported that Radial Extracorporeal Shock Wave Therapy (rESWT) is effective, but a meta-analysis concluded that due to methological limitations the evidence is questioned. There are few studies reporting the effect on exercise programs with high-load strength training, despite widespread use. The usual care at our outpatient clinic is information on the pathogenesis, etiology and prognosis. We give advice on using proper footwear, including foot orthosis and to accept pain to a certain level during activity. To our knowledge there are no other previous trials comparing rESWT, sham-rESWT and exercises to usual care. This trial is designed in order to provide results important for future clinical practice.
The patients who give their informed consent will be randomised into one of the four Groups; rESWT, sham-rESWT, standardized exercise or usual care. A computer generation randomisation schedule with blocks of 8, in a 1:1 ratio, will be performed by an external statistician and electronically concealed. All the patients regardless of group allocation will receive standardized information (oral and written) on the condition and get custom made foot orthosis made by an orthopedic technician at Sophies Minde AS.
The patients are blinded for rESWT/sham-rESWT, whereas blinding of the exercise group and usual care group is not possible. To evaluate the blinding of the rESWT, the patients are asked after the last treatment whether they believe that they have received real rESWT, sham-rESWT or if they do not know.
The patients will have follow-up at 3 months, 6 months and 12 months. The main outcome is change in heel pain (NRS) during activity at 6 months. Patient characteristics, anthropometric data and the duration of symptoms in the different groups will be registered at baseline, and presented as mean values (SD) for continuous variables or numbers (%) for categorical data. Pain and function scores will be presented as mean (SD). In addition to the two- group comparisons with t-tests, we will perform longitudinal data analysis and perform a mixed model analysis to compare differences between groups at follow- up with adjustment for scores at baseline and present mean differences (95% confidence intervals).
We will perform analysis regarding secondary outcome as stated above. In addition we will apply multivariable logistic and linear regression analysis to identify predictive factors as demographics, clinical and ultrasound findings for primary and secondary outcomes. Model building will be done in a way that is appropriate for the given sample sizes, by restricting the number of potential predictive factors and considering shrinkage methods to stabilise predictions.
Participants in the exercise group not attending 6 of 8 sessions with the physiotherapist or not completing 30 of 36 exercise sessions (3 sessions per week, 12 weeks) are regarded as non- adherence. In the rESWT and sham- rESWT group, participants not attending 2 of 3 sessions are regarded as non- adherence. They will be included in the intention- to- treat analysis. There will also be a separate intention-to- treat analysis with only adherent patients.
There will be performed a study evaluating the validity, reliability and responsiveness on the Foot Functional Index Revised Short Form.
- Conditions
- Plantar Fascitis
- Being tested
- Radial extracorporeal shock wave, Sham-radial extracorporeal shock wave, Standardized high-load exercise program, Usual care
- Keywords
- plantar fasciopathy, plantar fasciitis, radial extracorporeal shock wave therapy, sham- radial extracorporeal shock wave therapy, high-load strength training, foot orthosis
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial extracorporeal shock waveDevice
Patients will receive treatment once a week for 3 weeks. Treatment will be administered by using the rESWT device named Swiss DolorClast (EMS). 2000 impulses are implied via the power hand piece to the area of max tenderness at the insertion of the plantar fascia, with a pressure of 1.5-3 bars depending on what the patient tolerates. The treatments will be given by a trained physiotherapist at our Department.
Patients will also receive standardized information at baseline, and will get custom made foot orthosis.
Sham-radial extracorporeal shock waveDevice
Patients will receive the same treatment as the patients in the group receiving real shock waves, but no real shock waves are conducted. The probe is similar in design, sound and shape.
Patients will also receive standardized information at baseline, and will get custom made foot orthosis.
Standardized high-load exercise programBehavioural
Patients will be instructed to do 2 exercises: "Unilateral heel raise" and "unilateral leg squat" three times a week for 12 weeks. The patients will have a total of 8 sessions supervised by a physiotherapist at our Department.
Patients will also receive standardized information at baseline, and will get custom made foot orthosis.
Usual careBehavioural
Patients will get standardized information as in the other three intervention groups with information on pathogenesis, etiology and prognosis, and they will get custom made foot orthosis
| Study group | Role | What they receive |
|---|---|---|
| Radial extracorporeal shock wave | Active comparator | Active shock wave treatment. All patients will get standardized information and custom made foot orthosis. Receives: Device: Radial extracorporeal shock wave |
| Sham-radial extracorporeal shock wave | Sham comparator | Sham- shock wave treatment. All patients will get standardized information and custom made foot orthosis. Receives: Device: Sham-radial extracorporeal shock wave |
| Standardized high-load exercise program | Active comparator | High-load exercise treatment. All patients will get standardized information and custom made foot orthosis. Receives: Behavioral: Standardized high-load exercise program |
| Usual care | Active comparator | Only standardized information and custom made foot orthosis Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS)
Change in heel pain (during activity the last week ). Numeric rating scale is a patient reported pain intensity scale ranging from 0 (no pain) to 10 (worst possible pain).
Measured: 6 months
Secondary outcomes (5)
Foot Functional Index, revised, short Version (FFI-RS)
Change in Foot Health status. Consists of 34 questions.
Measured: 6 and 12 months
RAND- 12
Health related quality of life. 12 items.
Measured: 6 and 12 months
Numeric rating scale (NRS)
Change in heel pain (in rest the last week). Numeric rating scale is a patient reported pain intensity scale ranging from 0 (no pain) to 10 (worst possible pain).
Measured: 6 and 12 months
Numeric rating scale (NRS)
Change in heel pain (in activity the last week).Numeric rating scale is a patient reported pain intensity scale ranging from 0 (no pain) to 10 (worst possible pain).
Measured: 12 months
Patient Global Impression Of Change Scale (PGIC)
7-point scale ranging from "very much improved" to "very much worse"
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start21 Mar 2018
- Primary completion7 Sep 2022
- Study completion22 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Participants will be randomly assigned to one of the four intervention groups in parallell for the duration of the study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marte Heide, MD, Oslo University Hospital
- Investigators
- Aasne Fenne Hoksrud, MD, PhD, Study director, Oslo University hospital, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472989
- Sponsor's protocol ID
- 2017/1325
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2018
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rompe JD. Plantar fasciopathy. Sports Med Arthrosc Rev. 2009 Jun;17(2):100-4. doi: 10.1097/JSA.0b013e3181a3d60e.
PubMed 19440137Sun J, Gao F, Wang Y, Sun W, Jiang B, Li Z. Extracorporeal shock wave therapy is effective in treating chronic plantar fasciitis: A meta-analysis of RCTs. Medicine (Baltimore). 2017 Apr;96(15):e6621. doi: 10.1097/MD.0000000000006621.
PubMed 28403111Rathleff MS, Molgaard CM, Fredberg U, Kaalund S, Andersen KB, Jensen TT, Aaskov S, Olesen JL. High-load strength training improves outcome in patients with plantar fasciitis: A randomized controlled trial with 12-month follow-up. Scand J Med Sci Sports. 2015 Jun;25(3):e292-300. doi: 10.1111/sms.12313. Epub 2014 Aug 21.
PubMed 25145882Landorf KB. Plantar heel pain and plantar fasciitis. BMJ Clin Evid. 2015 Nov 25;2015:1111.
PubMed 26609884Gill LH. Plantar Fasciitis: Diagnosis and Conservative Management. J Am Acad Orthop Surg. 1997 Mar;5(2):109-117. doi: 10.5435/00124635-199703000-00006.
PubMed 10797213Ibrahim MI, Donatelli RA, Schmitz C, Hellman MA, Buxbaum F. Chronic plantar fasciitis treated with two sessions of radial extracorporeal shock wave therapy. Foot Ankle Int. 2010 May;31(5):391-7. doi: 10.3113/FAI.2010.0391.
PubMed 20460065Gerdesmeyer L, Frey C, Vester J, Maier M, Weil L Jr, Weil L Sr, Russlies M, Stienstra J, Scurran B, Fedder K, Diehl P, Lohrer H, Henne M, Gollwitzer H. Radial extracorporeal shock wave therapy is safe and effective in the treatment of chronic recalcitrant plantar fasciitis: results of a confirmatory randomized placebo-controlled multicenter study. Am J Sports Med. 2008 Nov;36(11):2100-9. doi: 10.1177/0363546508324176. Epub 2008 Oct 1.
PubMed 18832341Riel H, Jensen MB, Olesen JL, Vicenzino B, Rathleff MS. Self-dosed and pre-determined progressive heavy-slow resistance training have similar effects in people with plantar fasciopathy: a randomised trial. J Physiother. 2019 Jul;65(3):144-151. doi: 10.1016/j.jphys.2019.05.011. Epub 2019 Jun 13.
PubMed 31204294Rasenberg N, Riel H, Rathleff MS, Bierma-Zeinstra SMA, van Middelkoop M. Efficacy of foot orthoses for the treatment of plantar heel pain: a systematic review and meta-analysis. Br J Sports Med. 2018 Aug;52(16):1040-1046. doi: 10.1136/bjsports-2017-097892. Epub 2018 Mar 19.
PubMed 29555795Whittaker GA, Munteanu SE, Menz HB, Tan JM, Rabusin CL, Landorf KB. Foot orthoses for plantar heel pain: a systematic review and meta-analysis. Br J Sports Med. 2018 Mar;52(5):322-328. doi: 10.1136/bjsports-2016-097355. Epub 2017 Sep 21.
PubMed 28935689Frisaldi E, Shaibani A, Benedetti F. Why We should Assess Patients' Expectations in Clinical Trials. Pain Ther. 2017 Jun;6(1):107-110. doi: 10.1007/s40122-017-0071-8. Epub 2017 May 5.
PubMed 28477082Budiman-Mak E, Conrad KJ, Mazza J, Stuck RM. A review of the foot function index and the foot function index - revised. J Foot Ankle Res. 2013 Feb 1;6(1):5. doi: 10.1186/1757-1146-6-5.
PubMed 23369667Johnson JA, Maddigan SL. Performance of the RAND-12 and SF-12 summary scores in type 2 diabetes. Qual Life Res. 2004 Mar;13(2):449-56. doi: 10.1023/B:QURE.0000018494.72748.cf.
PubMed 15085917Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
PubMed 15621359Roe C, Heide M, Soberg HL, Brunborg C, Hoksrud AF, Myhre K, Brox JI, Mork M. One-Year Trajectory of Pain, Function, and Health-Related Quality of Life in Patients With Plantar Fasciopathy. J Foot Ankle Res. 2025 Sep;18(3):e70067. doi: 10.1002/jfa2.70067.
PubMed 40671207
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Radial Extracorporeal Shockwave Therapy (rESWT), Sham- rESWT, Standardised Exercise Program or Usual Care for Patients With Plantar Fasciopathy. Study Protocol for a Double-blind, Randomised Sham- Controlled Trial
- ClinicalTrials.gov ID
- NCT03472989
- Acronym / sponsor ID
- 2017/1325
- Conditions
- Plantar Fascitis
- Keywords
- plantar fasciopathy, plantar fasciitis, radial extracorporeal shock wave therapy, sham- radial extracorporeal shock wave therapy, high-load strength training, foot orthosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 21 Mar 2018 (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.
The purpose of this study is to evaluate whether radial extracorporeal shockwave therapy (rESWT), sham- rESWT or standardised exercise program is more effective on change in heel pain than usual care in the treatment of plantar fasciopathy.
The null hypothesis is: There is no difference between rESWT, sham- rESWT or standardised exercise program on change in heel pain (primary outcome) and functioning (secondary outcomes) compared to usual care in the treatment of plantar fasciopathy at 6 months follow-up (and secondary outcomes at the 12 months follow-up).
Alternative hypothesis is:
H1: There is a difference between rESWT and usual care on change in heel pain (and secondary outcomes) at the 6 months follow-up (and secondary outcomes at the 12 months follow-up).
H2: There is a difference between sham-rESWT and usual care on change in heel pain (and secondary outcomes ) at 6 months follow-up (and secondary outcomes at the 12 months follow-up).
H3: There is a difference between standardized exercise program and usual care on change in heel pain (and secondary outcomes) at 6 months follow- up (and secondary outcomes at the 12 months follow-up).
Detailed description
Plantar fasciopathy is a common cause of plantar heel pain, with reported lifetime prevalence up to 10%. The choice of best practice in these patients is debated. Two randomised studies reported that Radial Extracorporeal Shock Wave Therapy (rESWT) is effective, but a meta-analysis concluded that due to methological limitations the evidence is questioned. There are few studies reporting the effect on exercise programs with high-load strength training, despite widespread use. The usual care at our outpatient clinic is information on the pathogenesis, etiology and prognosis. We give advice on using proper footwear, including foot orthosis and to accept pain to a certain level during activity. To our knowledge there are no other previous trials comparing rESWT, sham-rESWT and exercises to usual care. This trial is designed in order to provide results important for future clinical practice.
The patients who give their informed consent will be randomised into one of the four Groups; rESWT, sham-rESWT, standardized exercise or usual care. A computer generation randomisation schedule with blocks of 8, in a 1:1 ratio, will be performed by an external statistician and electronically concealed. All the patients regardless of group allocation will receive standardized information (oral and written) on the condition and get custom made foot orthosis made by an orthopedic technician at Sophies Minde AS.
The patients are blinded for rESWT/sham-rESWT, whereas blinding of the exercise group and usual care group is not possible. To evaluate the blinding of the rESWT, the patients are asked after the last treatment whether they believe that they have received real rESWT, sham-rESWT or if they do not know.
The patients will have follow-up at 3 months, 6 months and 12 months. The main outcome is change in heel pain (NRS) during activity at 6 months. Patient characteristics, anthropometric data and the duration of symptoms in the different groups will be registered at baseline, and presented as mean values (SD) for continuous variables or numbers (%) for categorical data. Pain and function scores will be presented as mean (SD). In addition to the two- group comparisons with t-tests, we will perform longitudinal data analysis and perform a mixed model analysis to compare differences between groups at follow- up with adjustment for scores at baseline and present mean differences (95% confidence intervals).
We will perform analysis regarding secondary outcome as stated above. In addition we will apply multivariable logistic and linear regression analysis to identify predictive factors as demographics, clinical and ultrasound findings for primary and secondary outcomes. Model building will be done in a way that is appropriate for the given sample sizes, by restricting the number of potential predictive factors and considering shrinkage methods to stabilise predictions.
Participants in the exercise group not attending 6 of 8 sessions with the physiotherapist or not completing 30 of 36 exercise sessions (3 sessions per week, 12 weeks) are regarded as non- adherence. In the rESWT and sham- rESWT group, participants not attending 2 of 3 sessions are regarded as non- adherence. They will be included in the intention- to- treat analysis. There will also be a separate intention-to- treat analysis with only adherent patients.
There will be performed a study evaluating the validity, reliability and responsiveness on the Foot Functional Index Revised Short Form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned to one of the four intervention groups in parallell for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Radial extracorporeal shock wave | Active comparator | Device: Radial extracorporeal shock waveActive shock wave treatment. All patients will get standardized information and custom made foot orthosis. |
| Sham-radial extracorporeal shock wave | Sham comparator | Device: Sham-radial extracorporeal shock waveSham- shock wave treatment. All patients will get standardized information and custom made foot orthosis. |
| Standardized high-load exercise program | Active comparator | Behavioral: Standardized high-load exercise programHigh-load exercise treatment. All patients will get standardized information and custom made foot orthosis. |
| Usual care | Active comparator | Behavioral: Usual careOnly standardized information and custom made foot orthosis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pain with duration > 3 months localized in the proximal insertion of the plantar fascia on the medial calcaneal tuberosity.
- Only patients with reported pain NRS 3 or more at activity at baseline, will be included in the trial.
- Tenderness to palpation corresponding to the painful area.
- Be residents of Norway, understand oral and written Norwegian.
Key exclusion criteria (7 listed)
- Treatment with radial extracorporeal shock wave therapy the last 3 months.
- Spondylarthropathy or rheumatoid arthritis.
- Plantar fibromatosis.
- Tarsal tunnel syndrome.
- Polyneuropathy.
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 |
|---|---|---|
| Radial extracorporeal shock wavePatients will receive treatment once a week for 3 weeks. Treatment will be administered by using the rESWT device named Swiss DolorClast (EMS). 2000 impulses are implied via the power hand piece to the area of max tenderness at the insertion of the plantar fascia, with a pressure of 1.5-3 bars depending on what the patient tolerates. The treatments will be given by a trained physiotherapist at our Department. Patients will also receive standardized information at baseline, and will get custom made foot orthosis. | Device | Radial extracorporeal shock wave |
| Sham-radial extracorporeal shock wavePatients will receive the same treatment as the patients in the group receiving real shock waves, but no real shock waves are conducted. The probe is similar in design, sound and shape. Patients will also receive standardized information at baseline, and will get custom made foot orthosis. | Device | Sham-radial extracorporeal shock wave |
| Standardized high-load exercise programPatients will be instructed to do 2 exercises: "Unilateral heel raise" and "unilateral leg squat" three times a week for 12 weeks. The patients will have a total of 8 sessions supervised by a physiotherapist at our Department. Patients will also receive standardized information at baseline, and will get custom made foot orthosis. | Behavioural | Standardized high-load exercise program |
| Usual carePatients will get standardized information as in the other three intervention groups with information on pathogenesis, etiology and prognosis, and they will get custom made foot orthosis | Behavioural | Usual care |
Primary outcome
Numeric rating scale (NRS)
Time frame: 6 months
Change in heel pain (during activity the last week ). Numeric rating scale is a patient reported pain intensity scale ranging from 0 (no pain) to 10 (worst possible pain).
5 secondary outcomes
Foot Functional Index, revised, short Version (FFI-RS)
Time frame: 6 and 12 months
RAND- 12
Time frame: 6 and 12 months
Numeric rating scale (NRS)
Time frame: 6 and 12 months
Numeric rating scale (NRS)
Time frame: 12 months
Patient Global Impression Of Change Scale (PGIC)
Time frame: 6 and 12 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 17 Mar 2023.
- Background: PubMed 19440137Rompe JD. Plantar fasciopathy. Sports Med Arthrosc Rev. 2009 Jun;17(2):100-4. doi: 10.1097/JSA.0b013e3181a3d60e.
- Background: PubMed 28403111Sun J, Gao F, Wang Y, Sun W, Jiang B, Li Z. Extracorporeal shock wave therapy is effective in treating chronic plantar fasciitis: A meta-analysis of RCTs. Medicine (Baltimore). 2017 Apr;96(15):e6621. doi: 10.1097/MD.0000000000006621.
- Background: PubMed 25145882Rathleff MS, Molgaard CM, Fredberg U, Kaalund S, Andersen KB, Jensen TT, Aaskov S, Olesen JL. High-load strength training improves outcome in patients with plantar fasciitis: A randomized controlled trial with 12-month follow-up. Scand J Med Sci Sports. 2015 Jun;25(3):e292-300. doi: 10.1111/sms.12313. Epub 2014 Aug 21.
- Background: PubMed 26609884Landorf KB. Plantar heel pain and plantar fasciitis. BMJ Clin Evid. 2015 Nov 25;2015:1111.
- Background: PubMed 10797213Gill LH. Plantar Fasciitis: Diagnosis and Conservative Management. J Am Acad Orthop Surg. 1997 Mar;5(2):109-117. doi: 10.5435/00124635-199703000-00006.
- Background: PubMed 20460065Ibrahim MI, Donatelli RA, Schmitz C, Hellman MA, Buxbaum F. Chronic plantar fasciitis treated with two sessions of radial extracorporeal shock wave therapy. Foot Ankle Int. 2010 May;31(5):391-7. doi: 10.3113/FAI.2010.0391.
- Background: PubMed 18832341Gerdesmeyer L, Frey C, Vester J, Maier M, Weil L Jr, Weil L Sr, Russlies M, Stienstra J, Scurran B, Fedder K, Diehl P, Lohrer H, Henne M, Gollwitzer H. Radial extracorporeal shock wave therapy is safe and effective in the treatment of chronic recalcitrant plantar fasciitis: results of a confirmatory randomized placebo-controlled multicenter study. Am J Sports Med. 2008 Nov;36(11):2100-9. doi: 10.1177/0363546508324176. Epub 2008 Oct 1.
- Background: PubMed 31204294Riel H, Jensen MB, Olesen JL, Vicenzino B, Rathleff MS. Self-dosed and pre-determined progressive heavy-slow resistance training have similar effects in people with plantar fasciopathy: a randomised trial. J Physiother. 2019 Jul;65(3):144-151. doi: 10.1016/j.jphys.2019.05.011. Epub 2019 Jun 13.
- Background: PubMed 29555795Rasenberg N, Riel H, Rathleff MS, Bierma-Zeinstra SMA, van Middelkoop M. Efficacy of foot orthoses for the treatment of plantar heel pain: a systematic review and meta-analysis. Br J Sports Med. 2018 Aug;52(16):1040-1046. doi: 10.1136/bjsports-2017-097892. Epub 2018 Mar 19.
- Background: PubMed 28935689Whittaker GA, Munteanu SE, Menz HB, Tan JM, Rabusin CL, Landorf KB. Foot orthoses for plantar heel pain: a systematic review and meta-analysis. Br J Sports Med. 2018 Mar;52(5):322-328. doi: 10.1136/bjsports-2016-097355. Epub 2017 Sep 21.
- Background: PubMed 28477082Frisaldi E, Shaibani A, Benedetti F. Why We should Assess Patients' Expectations in Clinical Trials. Pain Ther. 2017 Jun;6(1):107-110. doi: 10.1007/s40122-017-0071-8. Epub 2017 May 5.
- Background: PubMed 23369667Budiman-Mak E, Conrad KJ, Mazza J, Stuck RM. A review of the foot function index and the foot function index - revised. J Foot Ankle Res. 2013 Feb 1;6(1):5. doi: 10.1186/1757-1146-6-5.
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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.
Aasne Fenne Hoksrud, MD, PhD study director
Oslo University hospital, Department of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial extracorporeal shock wave and Standardized high-load exercise program in people with Plantar Fascitis, run by Oslo University Hospital at 1 site in Norway.
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 4 inclusion and 7 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 17 Mar 2023. 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 Norway. 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?
Numeric rating scale (NRS) (time frame: 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 NCT03472989, which also lists 19 linked publications.
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 17 Mar 2023.