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IRCT20200521047525N2 IRCT 2021-05-16 Shahid Beheshti University of Medical Sciences Botulinum Toxin A Rolls in Foot and Ankle Muscular Disorders Short-Term Effect of Ultrasonography -Guided Botulinum Toxin A Injection in the Treatment of Foot and Ankle Disorders: A Multi-center Randomized, Triple-Blinded Study 2021-09-06 anticipated 180 Complete https://irct.ir/trial/48384 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will use restricted randomization to allocate equal patients in each group. We will do permuted block randomization to have 3 blocks of 60 patients (30 patients in intervention and 30 in the control group). Each block is for one of the 3 diseases of this study. we will first stratified randomization according to the center and use Random allocation software for randomization. For allocation concealment, we will use central randomization in Akhtar hospital (Tehran) and gather the data from the other two centers (Tajrish and Rasoul). We classify the samples according to the classification center, and then we generate a random sequence in each class with the help of randomization software. To hide random allocation, we use the central randomization method. Random sequencing is performed at Akhtar Hospital Center in Tehran and sampling is performed simultaneously at Tajrish and Rasoul Hospital centers in Tehran at the same time. The secretary in charge of the Akhtar Center, based on the order in which the participants entered the study, communicated with the secretary of the other center and asked about the random assignment of the participant to a special group. In the randomization process, the person who creates the random sequence, and the person who examines the participants in terms of inclusion and exit criteria is a secretary at Akhtar Hospital, which is responsible for maintaining information and confidentiality until the end of the study, Blinding description: We will use a triple-blinded study with blinding of participants, principle investigators, healthcare providers (Physicians, nurses, physiotherapists, etc.) who care for participants during the trial, outcome assessors (analyzer), and manuscript writer. The corresponding secretary in Akhtar, who will allocate randomization, and the other two center secretaries, who should report the randomization process will be alert about patients' specific group. 3 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 metatarsals. Condition 3: Achilles tendinitis (also Achilles tenosynovitis or Achilles tendinopathy) is tendinitis of the Achilles tendon, generally caused by overuse of the affected limb and is more common among athletes training under less than ideal conditions. 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 group, a similar volume of normal saline (1.5 liters) will be injected. Yes - There is a plan to make this available What will be shared: There is a plan to make clinical study reports and data of this study available to other researchers (typically after the end of the study). These data consist of all variables (except patient identification) for half of each group of participants (control/intervention) provided in SPSS format. When: En The start date of data availability will be in March 2023. To whom: Documents will be shared and available for researchers working in any academic institution. Conditions: Any requests to access all documents (for example for a systematic review) should be sent to the responsible researcher. Where to obtain: To contact the corresponding researcher: Email: mmvn93@gmail.com WhatsApp: 00989216361088 Linkedin: mohammad movahedinia How to obtain: After contacting the corresponding researcher, documents will be sent in one month Comments:
public Mohammad Movahedinia
Unit1, Floor1, No16, Alley Yousef, St Mirkhani, Sq Tohid
Tehran Iran (Islamic Republic of) 1419763594 +98 21 6694 8215 m.movahedinia@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mohammad Movahedinia
Unit1, Floor1, No16, Alley Yousef, St Mirkhani, Sq Tohid
Tehran Iran (Islamic Republic of) 1419763594 +98 21 6694 8215 m.movahedinia@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Clinically confirmed chronic achilles tendinopathy, metatarsalgia, or flat foot Proved chrionicity, described as: persistent pain (>6 months), despite medicaltreatment consisting of rest, analgesics, anti-inflammatories, localcorticosteroid injections, and/or physiotherapy. 18 years no limit Both age< 18 years osteoarticular pathology of the ankle fibromyalgia any conflict 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. M21.4 M77.4 M76.6 Flat foot [pes planus] (acquired) Metatarsalgia Achilles tendinitis Treatment - Drugs Placebo Intervention group: In this group, patients receive Botox injection of 70IU solution of botulinum type A (diluted in 10 ml of normal saline). Control group: In this group, a similar volume of normal saline (1.5 liters) will be injected. 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. 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. Shahid Beheshti University of Medical Sciences Approved 2021-01-31 Shahid Beheshti University of Medical Sciences Ethics Committee Shahid Beheshti University of Medical Sciences, Next to Ayatollah Taleghani Hospital, Evin, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)