Plantar Fasciitis of Both Feet, Plantar Fascitis
Conditions
Keywords
Exercise Therapy, Patient Education, Non-Inferiority Trial
Brief summary
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.
Detailed description
Plantar fasciitis is a common cause of chronic plantar heel pain and may lead to functional limitation and reduced quality of life. Exercise education is an important component of conservative treatment; however, in busy outpatient settings, the time available for detailed face-to-face instruction may be limited. Standardized video-based education may provide a practical alternative by delivering the same exercise content in a reproducible format. This study will evaluate whether video-based exercise instruction is non-inferior to physician-led face-to-face instruction in patients with plantar fasciitis. All participants will receive standard information about plantar fasciitis, load management, footwear recommendations, weight control, short-term analgesic or anti-inflammatory use when needed, and heel pad or insole support. The home exercise program will be identical in both groups and will include plantar fascia-specific stretching, gastrocnemius/soleus stretching, plantar fascia self-massage, gradual toe raises, and towel pull exercises. Assessments will be performed at baseline, 1 month, and 3 months after randomization. Functional status will be assessed using the Foot Function Index, and pain will be measured using a 0-10 numerical rating scale. Exercise knowledge, adherence, education duration, video viewing behavior, additional treatment use, and satisfaction will also be recorded.
Interventions
BEHAVIORALPhysician-Led Face-to-Face Exercise Instruction
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.
BEHAVIORALVideo-Based Exercise Instruction
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.
Sponsors
Balikesir Ataturk City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Because of the nature of the intervention, participants and treating physicians cannot be masked to group allocation. To reduce bias, standardized forms and predefined follow-up assessments will be used, and group codes will be used during statistical analysis.
Intervention model description
Participants will be randomized in a 1:1 ratio to either physician-led face-to-face exercise instruction or standardized video-based exercise instruction. The exercise content will be identical in both groups; only the method of instruction will differ.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Tenderness on palpation of the medial calcaneal tubercle * Baseline heel pain score of 4 or higher on a 0-10 numerical rating scale * Functional capacity to perform the prescribed exercises * Access to a smartphone, tablet, or computer to view the exercise video * Ability to provide written informed consent
Exclusion criteria
* 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 * Severe knee or hip osteoarthritis limiting exercise performance * Severe cognitive impairment preventing participation or completion of questionnaires * Pregnancy * Inability or unwillingness to comply with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Foot Function Index Total/Index Score From Baseline to 3 Months | Baseline and 3 months after randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Numeric Rating Scale Pain Score From Baseline to 1 and 3 Months | Baseline, 1 month, and 3 months after randomization | 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. |
| Change in Foot Function Index Pain Subscale Score From Baseline to 1 and 3 Months | Baseline, 1 month, and 3 months after randomization | 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. |
| Change in Foot Function Index Disability Subscale Score From Baseline to 1 and 3 Months | Baseline, 1 month, and 3 months after randomization | The disability subscale of the Foot Function Index will be used to assess foot-related functional disability. Higher scores indicate greater disability. |
Countries
Turkey (Türkiye)
Contacts
CONTACTgunes SARIKAYA
PRINCIPAL_INVESTIGATORgunes SARIKAYA
Balikesir Ataturk City Hospital
Outcome results
None listed