CompletedNot Applicable

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

Norway200 participantsStarted 2018-03-21

Plain-language 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. 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).

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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)

What they're measuring

Numeric rating scale (NRS)

Timeframe: 6 months

Trial details

NCT IDNCT03472989

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-07