NCT03472989

Plantar Fasciopathy and the Effectiveness of Radial Extracorporeal Shockwave Therapy, Physical Training or Usual Care

Completed NA Last updated 17 March 2023

What this trial tests

NA trial testing Radial extracorporeal shock wave in Plantar Fascitis in 200 participants. Completed in 22 February 2023.

Timeline

21 March 2018

Primary endpoint
7 September 2022

22 February 2023

Quick facts

Lead sponsor	Oslo University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	200
Start date	21 March 2018
Primary completion	7 September 2022
Estimated completion	22 February 2023
Sites	1 location across Norway

Drugs / interventions tested

• Radial extracorporeal shock wave
• Sham-radial extracorporeal shock wave
• Standardized high-load exercise program
• Usual care

Conditions studied

• Plantar Fascitis — all drugs for Plantar Fascitis →

Sponsor

Oslo University Hospital

Who can join

Adults 18 to 70, any sex, with Plantar Fascitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. The effectiveness of radial extracorporeal shock wave therapy (rESWT), sham-rESWT, standardised exercise programme or usual care for patients with plantar fasciopathy: study protocol for a double-blind, randomised, sham-controlled trial.
   Heide M, Mørk M, Røe C, Brox JI, et al · · 2020 · cited 12× · PMID 32600386 · DOI 10.1186/s13063-020-04510-z
2. Is radial extracorporeal shock wave therapy (rESWT), sham-rESWT or a standardised exercise programme in combination with advice plus customised foot orthoses more effective than advice plus customised foot orthoses alone in the treatment of plantar fasciopathy? A double-blind, ra
   Heide M, Røe C, Mørk M, Myhre K, et al · · 2024 · cited 7× · PMID 38904119 · DOI 10.1136/bjsports-2024-108139
3. The struggle to stay physically active-A qualitative study exploring experiences of individuals with persistent plantar fasciopathy.
   Mørk M, Soberg HL, Hoksrud AF, Heide M, et al · · 2023 · cited 7× · PMID 37061709 · DOI 10.1186/s13047-023-00620-4
4. Predictors for pain and functioning in patients with plantar fasciopathy one year after inclusion in a treatment trial in specialist care.
   Mørk M, Soberg HL, Heide M, Hoksrud AF, et al · · 2024 · cited 2× · PMID 39702178 · DOI 10.1186/s12891-024-08187-2
5. One-Year Trajectory of Pain, Function, and Health-Related Quality of Life in Patients With Plantar Fasciopathy.
   Røe C, Heide M, Søberg HL, Brunborg C, et al · · 2025 · cited 1× · PMID 40671207 · DOI 10.1002/jfa2.70067