Video-Based Versus Physician-Led Exercise Training for Plantar Fasciitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBalikesir Ataturk City Hospital

About this trial

This prospective, single-center, two-arm, parallel-group randomized non-inferiority trial will compare physician-led face-to-face exercise instruction with standardized video-based exercise instruction in adults with plantar fasciitis. Participants will be randomized in a 1:1 ratio to receive either face-to-face exercise training by an orthopedic physician or access to a standardized exercise video via QR code/web link. The exercise content will be identical in both groups; only the method of instruction will differ. The primary outcome will be the change in the Foot Function Index total/index score from baseline to 3 months. Secondary outcomes will include pain score, Foot Function Index subscales, exercise knowledge, exercise adherence, education time, video viewing status, additional treatment requirement, and patient satisfaction.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to 70 years

Clinical diagnosis of plantar fasciitis

Plantar heel pain lasting for at least 3 months

Heel pain that is most prominent with the first steps in the morning or after rest

Disqualifiers

Previous foot or ankle surgery on the affected side

History of foot fracture, foot tumor, advanced neuropathy, Charcot arthropathy, or tarsal tunnel syndrome

Corticosteroid injection, extracorporeal shock wave therapy, platelet-rich plasma injection, or other interventional treatment for plantar fasciitis within the last 6 months

Inflammatory arthritis or systemic rheumatologic disease affecting the foot

Trial design

Design model

Parallel

Treatments tested in this trial

  • Physician-Led Face-to-Face Exercise Instruction

    Behavioral

    Face-to-face instruction and demonstration of a standardized home exercise program by an orthopedic physician. The program includes plantar fascia-specific stretching, gastrocnemius/soleus stretching, plantar fascia self-massage, gradual toe raises, and towel pull exercises.

  • Video-Based Exercise Instruction

    Behavioral

    Access to a standardized home exercise video prepared by the study team via QR code or web link. Participants will be instructed to watch the video at home and perform the same exercise program used in the physician-led group.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Physician-Led Face-to-Face Exercise InstructionActive comparator 1 intervention
Group B: Video-Based Exercise InstructionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Foot Function Index Total/Index Score From Baseline to 3 Months

The Foot Function Index total/index score is a patient-reported measure of foot pain, disability, and activity limitation, converted to a 0-100 score. Higher scores indicate worse foot-related function. The primary endpoint will be the change from baseline to 3 months, calculated as baseline FFI score minus 3-month FFI score; higher positive values indicate greater clinical improvement.

Time frame
Baseline and 3 months after randomization

Secondary outcomes

1

Change in Numeric Rating Scale Pain Score From Baseline to 1 and 3 Months

Heel pain while walking during the previous week will be assessed using an 11-point numerical rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates unbearable pain. Change scores will be calculated from baseline to each follow-up visit.

Time frame
Baseline, 1 month, and 3 months after randomization
2

Change in Foot Function Index Pain Subscale Score From Baseline to 1 and 3 Months

The pain subscale of the Foot Function Index will be used to assess foot-related pain. Scores will be converted according to the standard Foot Function Index scoring method; higher scores indicate worse pain.

Time frame
Baseline, 1 month, and 3 months after randomization
3

Change in Foot Function Index Disability Subscale Score From Baseline to 1 and 3 Months

The disability subscale of the Foot Function Index will be used to assess foot-related functional disability. Higher scores indicate greater disability.

Time frame
Baseline, 1 month, and 3 months after randomization

Other outcomes

Sponsors and contacts

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