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Investigating the effect of sensory retraining technique on paresthesia and balance in patients with multiple sclerosis: a randomized clinical trial

Protocol summary

Study aim
Evaluating the Effect of Sensory Retraining Exercises on Paresthesia, Balance, Tactile Acuity and Quality of Life in Patients with Multiple Sclerosis
Design
A controlled, double group, single blinded (assessor), randomized, phase 3 clinical trial on 30 patients. For randomization permutational randomization method with the number of blocks 5 and block size 6 is used.
Settings and conduct
Individuals in both groups are selected from patients with MS who have been referred to centers under the supervision of SUMS. One group will receive sensory retraining exercises and Gabapentin or pregabalin, and another group will receive only drugs. The assessor and the therapist are not the same person, and in this way, the assessor will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years, Expanded Disability Status Scale less than 6, patient-reported paresthesia symptoms, score of at least 4 out of 10 in at least one of the symptoms of neuropathy on the visual scale in the legs in the past four weeks, balance disorder, no relapse of MS in at least the past 30 days. Exclusion criteria: Central or peripheral nervous system disorders such as head trauma, stroke, diabetes, Presence of any wounds or swelling at legs, Systemic diseases, pregnancy, lupus, use of tricyclic antidepressant and serotonin and norepinephrine reuptake inhibitors during the study period.
Intervention groups
treatment group: participants receive sensory retraining exercises in addition to the drug pregabalin or gabapentin. control group: participants receive pregabalin or gabapentin.
Main outcome variables
Paresthesia, Balance, Proprioception, 2-point discrimination, Texture of objects, Quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160221026674N7
Registration date: 2025-11-05, 1404/08/14
Registration timing: prospective

Last update: 2025-11-05, 1404/08/14
Update count: 0
Registration date
2025-11-05, 1404/08/14
Registrant information
Name
Marzieh Mohamadi
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
mohamadm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-06, 1404/08/15
Expected recruitment end date
2026-05-05, 1405/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of sensory retraining technique on paresthesia and balance in patients with multiple sclerosis: a randomized clinical trial
Public title
Investigating the effect of physiotherapy on sensory and balance problems in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Diagnosis of MS and confirmation of the diagnosis by a neurologist according to McDonald criteria and the patient's medical reports Extended Disability Status Scale (EDSS) score less than 6 Willing and able to comply with the study requirements Self-reported paresthesia symptoms including tingling, prickling, prickling, burning, crawling (like an insect moving across the skin), itching, partial numbness, and any abnormal sensation; score of at least 4 out of 10 on at least one of the symptoms of neuropathy (numbness, tingling, prickling, and any abnormal sensation) on a visual analogue scale in the legs in the past four weeks Balance Disorder Report: The Mini-Balance Evaluation Systems Test (Mini-BESTest) will be used. Absence of MS relapses for at least the past 30 days (defined as episodes of focal neurological impairment lasting more than 24 hours and without an alternative explanation).
Exclusion criteria:
Central or peripheral nervous system disorders such as head trauma, stroke, diabetes Presence of any wounds or swelling at the treatment site (legs) Systemic diseases Pregnancy lupus Use of Tricyclic antidepressants and Serotonin-norepinephrine reuptake inhibitors family drugs by patients during the study period
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to two groups of 15, intervention (sensory retraining exercises and drug therapy) and control (drug therapy), using a permutation randomization method with number of blocks of 5 and a block size of 6. Randomization will be performed manually by an epidemiologist. Random assignment of samples to groups is done with the ratio of 1:1 and with the help of numbered envelopes. Before performing the initial evaluation of each of the samples, the corresponding envelope is returned by the therapist at the Faculty of Rehabilitation Sciences in Shiraz.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor and the therapist are two different people, so the assessor is unaware of which of the two groups each participant is placed in.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Ethics committee, Research and Technology Vice-Chancellor, 7th floor, central building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
7198754361
Approval date
2025-07-30, 1404/05/08
Ethics committee reference number
IR.SUMS.REHAB.REC.1404.012

Health conditions studied

1

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

Primary outcomes

1

Description
Paresthesia intensity
Timepoint
Before the start of the intervention, immediately after the end of intervention course, 4 weeks after the end of the intervention
Method of measurement
Visual Analog Scale

Secondary outcomes

1

Description
Balance
Timepoint
Before the start of the intervention, immediately after the end of intervention course, 4 weeks after the end of the intervention
Method of measurement
Biodex balance SD

2

Description
Proprioception
Timepoint
Before the start of the intervention, immediately after the end of intervention course, 4 weeks after the end of the intervention
Method of measurement
Body position sense test

3

Description
Two-point discrimination
Timepoint
Before the start of the intervention, immediately after the end of intervention course, 4 weeks after the end of the intervention
Method of measurement
Sliding caliper

4

Description
The texture of objects
Timepoint
Before the start of the intervention, immediately after the end of intervention course, 4 weeks after the end of the intervention
Method of measurement
Testing the texture of objects with customized kit

5

Description
Quality of life
Timepoint
Before the start of the intervention, immediately after the end of intervention course, 4 weeks after the end of the intervention
Method of measurement
Quality of Life questionnaire

Intervention groups

1

Description
Intervention group: Sensory retraining exercises (4 weeks, 3 days a week, 60 minutes each time) with daily use of gabapentin (300 mg/day) or pregabalin (100 mg/day) for 4 weeks. The intervention consists of 4 sensory activities: stimulation of the sense of touch, recognition of the texture of objects, understanding the position of the limbs, and practice of two-point discrimination (ACTOVERCO Pharmaceutical Company).
Category
Treatment - Other

2

Description
Control group: Daily use of gabapentin (300 mg/day) or pregabalin (100 mg/day) for 4 weeks (ACTOVERCO Pharmaceutical Company).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Rehabilitation School, Shiraz University of Medical Sciences
Full name of responsible person
Marzieh mohamadi
Street address
Mehr Building, Shahid Chamran Hospital, Shahid Chamran Boulevard
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3624 0101
Email
rehabdep@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid mohammadi
Street address
Research and Technology Vice-Chancellor, 7th floor, central building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh mohamadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Shahid Doran Campus, after Amir-al-momenin Burn Accident Hospital, Sadra Town Road
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3212 2600
Email
mohamadm@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh mohamadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Shahid Doran Campus, after Amir-al-Momenin Burn Accident Hospital, Sadra Town Road
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3212 2600
Email
mohamadm@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh mohamadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, after Amir-al-Momenin Burn Accident Hospital, Shahid Doran Campus, Sadra Town Road
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3212 2600
Email
mohamadm@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information collection form including primary and secondary outcomes, informed consent form and SPSS file
When the data will become available and for how long
After publication the results of the study
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Only for recording information in scientific databases
From where data/document is obtainable
Correspondence with the project manager by email. mohamadm@sums.ac.ir
What processes are involved for a request to access data/document
Maximum one month after sending the request by email
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