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Shockwave therapy and exercise for plantar heel pain: A pilot study

Comparison of Radial Extracorporeal shockwave therapy, physiotherapy, and a combined intervention for plantar fasciopathy: a mixed methods pilot RCT.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN82762757
Enrollment
48
Registered
2019-07-31
Start date
2019-04-01
Completion date
Unknown
Last updated
2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plantar fasciopathy Musculoskeletal Diseases

Interventions

Group I: Radial Shockwave therapy following standardized protocol (EMS Swiss DolorClast), performed 3x in weekly intervals (Week 1, 2 and 3) combined with Plantar fascia-specific strengthening and str

Sponsors

Robert Gordon University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults over the age of 18 2. Diagnosis of plantar fasciopathy by referring clinician to include: 2.1 Heel Pain in the morning or after sitting for extended periods 2.2 Localised pain on palpation where the plantar fascia attaches to the heel – medial calcaneal tuberosity 2.3 Increased pain with walking or standing for extended periods 3. History of at least 3 months of heel pain prior to beginning trial 4. Willingness to abstain from any other treatments during the trial 5. Signed informed consent form

Exclusion criteria

Exclusion criteria: 1. Neurological abnormalities, peripheral neuropathy or nerve entrapment syndromes (e.g., tarsal tunnel syndrome) 2. Infections or tumours of the lower extremity, active malignancy 3. Vascular abnormality (e.g., severe varicosities, ischaemia) 4. Arthrosis or arthritis of the foot, rheumatoid arthritis 5. Systemic inflammatory disease, osteomyelitis 6. Dysfunction of the foot or ankle (e.g. chronic instability) 7. Corticosteroid injection or shockwave therapy within 6 weeks of beginning trial interventions 8. Calcaneal stress fracture, plantar fascia rupture or previous surgery for heel spur or plantar fascia 9. Bleeding disorder or haemophilia or active coagulation therapy 10. Cardiac pacemaker 11. Pregnancy

Design outcomes

Primary

MeasureTime frame
This is a pilot study. Primary outcome will be the efficacy of the study procedure, including participant recruitment, retention, intervention acceptability, trial procedures and process evaluation. Acceptability will be measured by patient interview.

Secondary

MeasureTime frame
1. Change of the sum score of the Revised Foot function Index (FFI-R) from baseline to month one, month three and month six. 2. Change of the sum score of Foot and Ankle Ability Measure (FAAM) from baseline to month one, month three and month six. 3. Change of 100mm Vas pain scale from baseline to month one, month three and month six. 4. Change of Roles and Maudsley Score from baseline to month one, month three and month six. 5. Change of EQ-5D-5L Quality of life score from baseline to month one, month three and month six. 6. Global rating of change (GRoC) score from baseline to month one, month three and month six.

Countries

Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026