Shockwave therapy and exercise for plantar heel pain: A Pilot study
Research type
Research Study
Full title
Comparison of Extracorporeal shockwave therapy, exercise, and a combined intervention for plantar fasciopathy: a mixed methods pilot RCT.
IRAS ID
261311
Contact name
Kay Cooper
Contact email
Sponsor organisation
Robert Gordon University
Duration of Study in the UK
1 years, 0 months, 14 days
Research summary
Musculoskeletal disorders are having an increasing burden on society with costs to healthcare systems and individuals. Heel pain known as Plantar fasciopathy is a common musculoskeletal disorder of the foot, resulting in chronic pain and impaired function. Extracorporeal shockwave therapy (ESWT) involves using mechanical shockwaves applied from an electrical device outside the body to stimulate healing in chronic musculoskeletal disorders. In clinical practice, ESWT is often used in combination with exercise, although this has been poorly addressed in previous studies. Specific exercises and ESWT alone for plantar fasciopathy have been found to be effective treatment interventions in randomised controlled trials (RCTs). However there have been no studies comparing these two interventions against each other and a combined intervention. A three-arm RCT comparing these three groups would be the ideal way to determine the most effective treatment protocol for plantar fasciopathy. There have also been no qualitative studies investigating patients’ perceptions, expectations and acceptability of these interventions. Therefore, the proposed mixed methods study will involve a pilot RCT with qualitative semi-structured interviews. Participants with heel pain of 3 months or longer will be recruited from NHS podiatry, the general population and from Robert Gordon University (RGU). Participants will be randomised to three groups, and receive 3 treatment sessions at RGU physiotherapy clinic, with outcome measures completed 1 and 3-months following treatment. The pilot RCT will test trial procedures and process evaluation and allow calculations of effect sizes from outcome measures, allowing for a future larger-scale RCT to be adequately powered. This future RCT would be adequately powered to determine effectiveness of the interventions, allowing for recommendations. This method of pilot testing the procedures prior to the larger-scale RCT is recommended for complex health interventions. The qualitative semi-structured interviews will allow investigation of patients’ perceptions, expectations and acceptability of these interventions. Not only would this data help explain the intervention outcomes it would help in determining if these interventions are acceptable to patients in clinical practice.
REC name
North of Scotland Research Ethics Committee 1
REC reference
19/NS/0119
Date of REC Opinion
29 Jul 2019
REC opinion
Favourable Opinion