Condition 1: Flat feet (also called pes planus or fallen arches) is a postural deformity in which the arches of the foot collapse, with the entire sole of the foot coming into complete or near-complete contact with the ground. Condition 2: Metatarsalgia, literally metatarsal pain and colloquially known as a stone bruise, is a general term used to refer to any painful foot condition affecting the metatarsal region of the foot. This is a common problem that can affect the joints and bones of the m
Conditions
Interventions
Intervention 1: Intervention group: In this group, patients receive Botox injection of 70IU solution of botulinum type A (diluted in 10 ml of normal saline). Intervention 2: Control group: In this gro
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Clinically confirmed chronic achilles tendinopathy, metatarsalgia, or flat foot Proved chrionicity, described as: persistent pain (>6 months), despite medicaltreatment consisting of rest, analgesics, anti-in?ammatories, localcorticosteroid injections, and/or physiotherapy.
Exclusion criteria
Exclusion criteria: age< 18 years osteoarticular pathology of the ankle ?bromyalgia any con?ict of interest associated with the patient’spain, including an unresolved workplace injury or ongoing legal proceedings for compensation; or postoperative symptoms. radiculopathy or disc herniation history systemic inflammatory diseases peripheral neuropathic diseases e.g diabetes contraindications to intramuscular BoNT-A injection, including suspected pregnancy, breastfeeding, a history of neuromuscular pathology, or current anticoagulant or aminoglycoside treatment. Patients who hadreceived BoNT-A injections previously were excluded to avoidtreatment ineffectiveness due to immunization against BoNT-A.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS score: The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between “no pain” and “worst pain.”. Timepoint: Comparison of visual analog scale (VAS) between intervention and placebo groups in two time periods before injection and 3 months after injection. Method of measurement: The visual analog scale (VAS).;Function assessment by American Orthopaedic Foot and Ankle Society (AOFAS) questionnaire range from 0 to 100, with healthy ankles receiving 100 points. Timepoint: Comparison of visual analoge scale (VAS) between intervention and placebo groups in two time periods before injection and 3 months after injection. Method of measurement: AOFAS questionnaire.;Ankle dorsiflexion measured as degree in physical exam. Timepoint: Comparison of visual analoge scale (VAS) between intervention and placebo groups in two time periods before injection and 3 months after injection. Method of measurement: physical exam.;Calf power as standing time on one toe (seconds). Timepoint: Comparison of visual analoge scale (VAS) between intervention and placebo groups in two time periods before injection and 3 months after injection. Method of measurement: physical exam. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life 0-100 (No interference - complete interference with life). Timepoint: Comparison of VAS score between intervention and placebo groups in two time periods before injection and 3 months after injection. Method of measurement: Asking the patient.;Patient satisfaction with the injection (Absolutely - to some extent - not at all). Timepoint: Comparison of VAS score between intervention and placebo groups in two time periods before injection and 3 months after injection. Method of measurement: Asking the patient.;Symptom improvement rate based on Likert (worsening-unchanged-slightly better-completely better). Timepoint: Comparison of VAS score between intervention and placebo groups in two time periods before injection and 3 months after injection. Method of measurement: Asking the patient.;Tendency to inject the same in yourself or loved ones (strongly agree - somewhat agree - not at all). Timepoint: Comparison of VAS score between intervention and placebo groups in two time periods before injection and 3 months after injection. Method of measurement: Asking the patient. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Movahedinia
Shahid Beheshti University of Medical Sciences
Outcome results
None listed