The goal of this clinical trial is to learn whether focused extracorporeal shockwave therapy (ESWT) provides better outcomes than radial ESWT for adults with plantar fasciitis. It will also learn about the safety and tolerability of both treatments.
The main questions it aims to answer are:
1. Does focused ESWT lead to greater improvement in heel pain than radial ESWT? 2. Does focused ESWT improve foot function more than radial ESWT? 3. Do participants experience less discomfort during focused ESWT compared with radial ESWT? 4. What medical problems or side effects occur with either treatment?
Researchers will compare focused ESWT to radial ESWT to see whether one treatment offers better clinical outcomes or is better tolerated.
Participants will:
1. Receive three shockwave treatment sessions (radial or focused), one week apart 2. Attend clinic follow-up assessments at 6 weeks, 12 weeks, 6 months, and 12 months 3. Complete questionnaires about heel pain and foot function Keep a diary of symptoms, daily pain levels, activity limitations, and any use of pain medication
ultrasound scan (USS); or
magnetic resonance imaging (MRI); 6. able to understand the study and provide written informed consent; 7. sufficient spoken and written English to understand the study information and complete the planned questionnaires and telephone follow-up assessments
previous ESWT to the affected study foot;
corticosteroid injection to the affected region within the preceding 3 months;
previous plantar fascia surgery;
an alternative diagnosis considered to be the principal cause of the heel pain;
Parallel
Focused Shockwave therapy
DevicePatients will be randomly allocated to focused shockwave therapy. The settings with regards to the waves will be pre-determined and will be the normal setting usually used by the department They will have one session every week for 3 weeks We will chase them up with outcome at 6 weeks, 12 weeks, 6 months and 12months.
Radial shockwave therapy
DevicePatients will be randomly allocated to radial shockwave therapy The setting for the shockwave will be pre-determined as advised by the literature and manufacturers of the device They will have one session every week for 3 weeks We will chase them up with outcome at 6 weeks, 12 weeks, 6 months and 12months.
Average Heel pain at 12 weeks using a numerical rating scale ranging from 0 - 10
To compare the clinical effectiveness of radial versus focused Extracorporeal shockwave therapy (ESWT) for chronic plantar heel pain by assessing the difference between treatment groups in average heel pain at 12 weeks, adjusted for baseline pain. The numerical rating scale ranges from 0 - 10 with 10 being a worse outcome
To compare the effect of radial and focused shockwave therapy on foot related function using the modified Foot Function Index (FFI) questionnaire
The modified foot function index is a 23 item questionnaire with a 0 - 10 numerical scale response. Higher scoring tends to indicate worse outcome. This questionnaire will be done at baseline, 6 weeks, 12 weeks, 6 months and 12 months
Comparing first step heel pain after radial vs focused shockwave therpay using a numerical rating scale from 0 - 10
This will be recorded at baseline, 6 weeks, 12 weeks, 6 months and 12 months. A higher score indicates a worse outcome
To compare procedural treatment discomfort after radial vs focused shockwave therapy using a numerical rating scale (ranging 0-10)
This will be recorded after each treatment session. There are 3 treatment session in total happening in 3 consecutive weeks, once a week A higher score indicates a worse outcome
Patient-reported global improvement following radial vs focused shockwave therapy using a Likert scale
This will be recorded at 6 weeks, 12 weeks, 6 months and 12 months. The likert scale is as follows: Compared with before shockwave treatment, how is your heel pain now? Much worse Worse no change Better Much better
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This trial is not recruiting at the moment. You can still explore other options:
