Efficacy of individualized homoeopathic medicines in the pain management of plantar fasciitis in adults: A double-blind, randomized, placebo-controlled trial
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Foot Function Index (FFI)
Study Overview
Brief Summary
Plantar fasciitis (PF) is a chronic degenerative condition causing marked thickening and fibrosis of the plantar fascia, and collagen necrosis, chondroid metaplasia, and calcification. Microtears at the calcaneal origin of the plantar fascia, provoking an inflammatory response thought to be produced by repetitive traction of the plantar fascia during walking or running [2]. Patients usually complain of pain at the anteromedial prominence of the calcaneum. The pain is exacerbated by passive dorsiflexion of the toes. Symptoms may have been present for weeks or months at the time of presentation. The pain is worse when first standing after rest, typically early in the morning. Once the patient starts walking, the pain tends to recede. Obesity and reduced ankle dorsiflexion are recognized risk factors for the condition. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of IHMs in the pain management of patients with plantar fasciitis in adults. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 106 adults who are suffering from plantar fasciitis at the outpatient department of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by Foot Function Index (FFI) [primary outcomes], MYMOP-2 (Measure Yourself Medical Outcome Profile) [secondary outcomes], and Short-Form McGill Pain Questionnaire 1.0 (SF-MPQ) every month up to 3 months. Comparative analysis will be carried out to detect group differences.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Cases suffering from PF for a minimum of 12 weeks
- •Had not taken any form of treatment for the past 2 weeks
- •Age between 18 and 65 years.
- •Participants of either sex or transgender.
Exclusion Criteria
- •Patient denying consent to participate in the trial.
- •Vulnerable population – unconscious, non-ambulatory, too sick for consultation; differently abled; or terminally or critically ill subjects
- •Suffering from calcaneal spur or any bony deformity or foot pathology (ex.
- •Flat foot)
- •Elevated serum uric acid level.
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure
- •Pregnant and puerperal women, lactating mothers
- •Tobacco chewing and/or smoking, alcoholism, and/or any other form(s) of substance abuse and/or dependence
- •Undergoing homeopathic treatment for any chronic disease(s) within last 6 months
- •Simultaneous participation in any other clinical trials.
Outcomes
Primary Outcomes
Foot Function Index (FFI)
Time Frame: At baseline, monthly up to 3 months
Secondary Outcomes
- McGill Pain Questionnaire 1.0 (SF-MPQ)(At baseline, monthly up to 3 months)
- Measure Yourself Medical Outcome Profile version 2 (MYMOP-2)(At baseline, monthly up to 3 months)
Investigators
Sudipta Samanta
D.N.De Homoeopathic Medical College and Hospital