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Evaluation of the effect of extracorporeal shockwave therapy after botulinum toxin injection on cuff muscle spasticity improvement in patients with multiple sclerosis

Protocol summary

Study aim
Determining the effect of extracorporeal shock wave therapy after botulinum toxin injection on cuff muscle spasticity improvement in patients with multiple sclerosis
Design
A randomized, single-blinding clinical trial, with the parallel groups, Phase 2 on 20 patients
Settings and conduct
In this randomized single-blind clinical trial study, 20 eligible patients referred to Alzahra and Kashani hospitals in Isfahan will be included in the study and will be randomly divided into two groups. For patients in the first group, only botulinum toxin is injected according to the standard protocol. Patients in the second group are treated with extracorporeal shockwave after botulinum toxin injection. Then the spasticity score and the pain score due to spasticity are evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria included a definitive diagnosis of multiple sclerosis based on the opinion of a neurologist, presence of spasticity in the cuff muscles (based on a score of more than 1 on the modified Ashworth scale (MAS), and consent to participate in the study. Exclusion criteria include having a cognitive impairment (in advanced stages of the disease), having myopathy or peripheral nerve disease, having a pacemaker, pregnancy, pre-injection of botulinum toxin during the last 6 months, having cuff muscle atrophy, having coagulation disorders, have a history of surgery or previous fractures at the site of muscle spasticity.
Intervention groups
Control group: In this group, only botulinum toxin injection with BTX-A was performed for the patient under the standard protocol. For this purpose, 100-200 mU of Botox type A, Dysport is used. spasticity is injected. Intervention group: IIn this group, after injecting botulinum toxin, extracorporeal shock wave therapy is performed.
Main outcome variables
Spasticity score; Pain score due to spasticity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200825048515N41
Registration date: 2021-09-27, 1400/07/05
Registration timing: registered_while_recruiting

Last update: 2021-09-27, 1400/07/05
Update count: 0
Registration date
2021-09-27, 1400/07/05
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of extracorporeal shockwave therapy after botulinum toxin injection on cuff muscle spasticity improvement in patients with multiple sclerosis
Public title
Evaluation of the effect of extracorporeal shockwave therapy after botulinum toxin injection on cuff muscle spasticity improvement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of multiple sclerosis based on the opinion of a neurologist Presence of spasticity in the cuff muscles (based on a score of more than 1 on the modified Ashworth scale (MAS) consent to participate in the study
Exclusion criteria:
Having cognitive disorders (in advanced stages of the disease) Having myopathy or peripheral nerve disease Having a pace maker Pregnancy Pre-injection of botulinum toxin during the last 6 months Having cuff muscle atrophy Having coagulation disorders History of previous surgery or fracture at the site of spastic muscles
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
First, eligible patients will likely be selected sequentially. Then random numbers are created by computer software "Random Allocation". We randomly divide these numbers into two parts. Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the current study, the researcher is aware of the type of intervention in each of the two groups, but the patient and the evaluator (data collector) are not aware of the type of surgery in each group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2019-10-09, 1398/07/17
Ethics committee reference number
IR.MUI.MED.REC.1398.351

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Pain
Timepoint
Before, immediately, 2 weeks and 8 weeks after the intervention
Method of measurement
Visual Analogue Scale (VAS)

2

Description
Spasticity score
Timepoint
Before, immediately, 2 weeks, and 8 weeks after the intervention
Method of measurement
Modified Ashworth's Scale (MAS)

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In this group, only botulinum toxin injection with BTX-A was performed for the patient under the standard protocol, for this purpose, 100-200 mU of Botox type A, Dysport is used. This injection is performed in the medial and lateral heads of the cuff muscle based on the severity of the spasticity.
Category
Treatment - Drugs

2

Description
Intervention group: In this group, after injection of botulinum toxin with BTX-A according to the standard protocol, it is treated with extracorporeal shock wave therapy. For this purpose, radial energy is used with an intensity of 4 times and the its frequency is 8 Hz. The number of shocks is 2000 shocks on the gastrocnemius muscles, 600 shocks on the soleus muscle and 200 shocks on the Achilles tendon. The number of sessions is 5 sessions once a week. The device used for ESWT is Nortz Medical- Duolith SD1.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Shila Haghighat
Street address
Department of Physical Medicine and Rehabilitation, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Haghighatshila@gmail.com

2

Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Shila Haghighat
Street address
Department of Physical Medicine and Rehabilitation, Kashani Hospital, Kashani Street.
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
Haghighatshila@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Shila Haghighat
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Haghighatshila@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shila Haghighat
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Haghighatshila@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Marjan Ghasri
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
Marjaghasri25@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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