A clinical trial to study the effects of two foot insoles, customized total contact insole and silicone insole in patients with plantar fasciitis.
Phase 2
- Conditions
- Health Condition 1: M722- Plantar fascial fibromatosis
- Registration Number
- CTRI/2023/10/058929
- Lead Sponsor
- Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
a. Subject age between 18 to 60 years
b. Unilateral involvement of plantar fasciitis
c. Heel Pain more than 4 on VAS scale attached in.
d. History of Plantar Heel pain for at least 1 month
Exclusion Criteria
a. Previous surgical intervention of foot
b. Acute heel trauma due to fall or any injury.
c. Flat feet
d. Plantar fasciitis due to systemic rheumatic disease, neuropathic pain or any local infection.
e. Pregnancy
f. Coagulation disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Foot & Ankle Outcome Score (FAOS) will be used to assess the outcome of orthotic insoles. <br/ ><br> It consists of 42 questions, divided into five subscales- pain, symptoms, activities of daily living (ADL), quality of life (QOL) & sports & recreation. Each question gets a score from 0 to 4 on a Likert scale, & the raw subscale scores are calculated from the sum of individual scores. The subscale scores are converted into normalized score out of 100, whereby 100 depicts normal function & 0 represents extreme dysfunction.Timepoint: 3 weeks with orthosis
- Secondary Outcome Measures
Name Time Method nilTimepoint: nil