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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

Protocol summary

Study aim
Evaluation of short-term effects of Botox in improving the symptoms of patients with Achilles tendinopathy
Design
We intend to investigate for the first time the effects of Botox on the improvement of symptoms by conducting a randomized, multi-center, triple-blinded, placebo-controlled clinical trial (Phase III) with three months of follow-up. Patients with Achilles tendinopathy, metatarsalgia, or plantar fasciitis. The number of participants in each group is 30 randomly selected using randomization software. The exact injection site is determined by an ultrasound-guided radiologist.
Settings and conduct
Patients will be selected from three medical centers (Akhtar, Rasoul, and Tajrish Hospital). All participants will confirm the informed consent form as well as the description of the treating physician. The patients, the doctors, and the statistical analyst of this project will not know the identity of the patients in each group (triple blindness).
Participants/Inclusion and exclusion criteria
Clinically confirmed chronic Achilles tendinopathy, metatarsalgia, or flat foot are included. Exclusion criteria include age< 18 years osteoarticular pathology of the ankle fibromyalgia radiculopathy or disc herniation history systemic inflammatory diseases peripheral neuropathic diseases and any contraindications to intramuscular BoNT-A injection.
Intervention groups
Subcutaneous injection of Botox at a dose of 70 IU of botulinum solution type A (diluted in 10 ml of normal saline) in the one-third proximal area of the medial head of the gastrocnemius for the intervention group and a similar volume of normal saline (1.5 liters) in the control group.
Main outcome variables
Patient pain, patient function, calf power, and ankle dorsiflexion, quality of life, and injection satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200521047525N2
Registration date: 2021-05-16, 1400/02/26
Registration timing: prospective

Last update: 2021-05-16, 1400/02/26
Update count: 0
Registration date
2021-05-16, 1400/02/26
Registrant information
Name
Mohammad Movahedinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 8215
Email address
m.movahedinia@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2023-03-06, 1401/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Botulinum Toxin A Rolls in Foot and Ankle Muscular Disorders
Purpose
Treatment
Inclusion/Exclusion 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-inflammatories, localcorticosteroid injections, and/or physiotherapy.
Exclusion criteria:
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.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences Ethics Committee
Street address
Shahid Beheshti University of Medical Sciences, Next to Ayatollah Taleghani Hospital, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2021-01-31, 1399/11/12
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.1005

Health conditions studied

1

Description of health condition studied
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.
ICD-10 code
M21.4
ICD-10 code description
Flat foot [pes planus] (acquired)

2

Description of health condition studied
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.
ICD-10 code
M77.4
ICD-10 code description
Metatarsalgia

3

Description of health condition studied
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.
ICD-10 code
M76.6
ICD-10 code description
Achilles tendinitis

Primary outcomes

1

Description
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)

2

Description
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

3

Description
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

4

Description
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 outcomes

1

Description
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

2

Description
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

3

Description
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

4

Description
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

Intervention groups

1

Description
Intervention group: In this group, patients receive Botox injection of 70IU solution of botulinum type A (diluted in 10 ml of normal saline).
Category
Treatment - Drugs

2

Description
Control group: In this group, a similar volume of normal saline (1.5 liters) will be injected.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Akhtar hospital
Full name of responsible person
Mohammad Movahedinia
Street address
Unit1, Floor1, No16, Alley Yousef, St Mirkhani, Sq Tohid
City
Tehran
Province
Tehran
Postal code
1419763594
Phone
+98 21 6694 8215
Email
mmvn93@gmail.com

2

Recruitment center
Name of recruitment center
Hazrate Rasoole Akram Hospital
Full name of responsible person
Mohammad Movahedinia
Street address
Unit1, Floor1, No16, Alley Yousef, St Mirkhani, Sq Tohid
City
Tehran
Province
Tehran
Postal code
1419763594
Phone
+98 21 6694 8215
Email
mmvn93@gmail.com

3

Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Amir Sadaghzadeh
Street address
Shohada Tajrish Hospital, Tajrish Square, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
dramirsabbaghzadeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
5th Floor, Bldg No.2, SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9780
Fax
+98 21 2243 9981
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Movahedinia
Position
Orthopaedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Unit1, Floor1, No16, Alley Yousef, St Mirkhani, Sq Tohid
City
Tehran
Province
Tehran
Postal code
1419763594
Phone
+98 21 6694 8215
Email
m.movahedinia@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Movahedinia
Position
Orthopaedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Unit1, Floor1, No16, Alley Yousef, St Mirkhani, Sq Tohid
City
Tehran
Province
Tehran
Postal code
1419763594
Phone
+98 21 6694 8215
Email
m.movahedinia@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Movahedinia
Position
Orthopaedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Unit1, Floor1, No16, Alley Yousef, St Mirkhani, Sq Tohid
City
Tehran
Province
Tehran
Postal code
1419763594
Phone
+98 21 6694 8215
Email
m.movahedinia@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
En The start date of data availability will be in March 2023.
To whom data/document is available
Documents will be shared and available for researchers working in any academic institution.
Under which criteria data/document could be used
Any requests to access all documents (for example for a systematic review) should be sent to the responsible researcher.
From where data/document is obtainable
To contact the corresponding researcher: Email: mmvn93@gmail.com WhatsApp: 00989216361088 Linkedin: mohammad movahedinia
What processes are involved for a request to access data/document
After contacting the corresponding researcher, documents will be sent in one month
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