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

Table 1 Schedule of enrolment, interventions, and assessments during the study period

	Enrolment	Allocation	Interventions	Follow-up
Time point	0	0	0–3 months	3 months	6 months	12 months
Enrolment:
Eligibility screen	X
Informed consent	X
Allocation		X
Interventions:
rESWT			X
Sham-rESWT			X
Exercise programme			X
Usual care 1)			X
Assessments:
Baseline variables 2)	X
NRS 3)	X			X	X	X
FFI-RS 4)	X			X	X	X
RAND-12	X			X	X	X
PGIC 5)				X	X	X
Other data variables 6)				X	X	X
Clinical examination and ultrasound 7)	X				X	X

1) Usual care: all patients get the same information before randomisation. 2) Baseline variables: age, gender, relationship status, education, work situation, sick leave, duration of symptoms, previous treatment, previous radial shock wave treatment, use of pain medication, physical activity, smoke/non-smoker, expectations of change in foot pain, which treatment the patient hopes he/she will get in the trial. 3) NRS: numeric rating scale.4) FFI-RS: Foot Functional Index Revised Short Version. 5) PGIC: Patient Global Impression of Change. 6) Other variables: use of foot orthosis, side effects of treatment, use of other treatment modalities, use of pain medication. 7) Clinical examination includes palpation of the ankle and foot including the insertion of the plantar fascia, weight-bearing ankle dorsiflexion motion, calf-raise test. In addition and only at inclusion: height, weight, body mass index, measurement of calf circumference, passive range of motion in the ankle joint. Ultrasound measurement includes thickness in millimetres, hypoechogenicity (presence/no presence), neovascularization (presence/no presence) and calcification (presence/no presence)

ISSN: 1745-6215