Protocol summary

Study aim
Evaluation of the effect of ultrasound therapy and nerve gliding techniques in patients with carpal tunnel syndrome
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, phase 3 on 48 patients. The block method will be used for randomization.
Settings and conduct
A study in Imam Reza Birjand Hospital, South Khorasan Province, on 48 patients who were randomly divided into two treatment groups: ultrasound and neurogliding techniques. Patients are evaluated at the beginning of the study and 4 weeks after the start of the study
Participants/Inclusion and exclusion criteria
Patients suffering from carpal tunnel syndrome refer to Imam Reza hospital clinic in Birjand city. Inclusion criteria: No need for surgery, no use of non-steroidal anti-inflammatory drugs or steroids, balanced mental status and consent to participate in the research and exclusion criteria: Patients under 18 years of age, pregnant women, reports of previous treatment of the syndrome with ultrasound or laser or regular use of analgesic and anti-inflammatory drugs, use of local steroid injections inside the carpal tunnel during the last year or during the study, severe atrophy of the thenar region, history of to malignant tumors, suffering from peripheral system neuropathy, suffering from any disease that affects the results of the study Irregular attendance in treatment programs.
Intervention groups
Patients with carpal tunnel syndrome referring to Imam Reza Hospital Clinic, Birjand city, were randomly assigned to two ultrasound groups A (frequency of 1 megahertz, current intensity of 1 watt per square centimeter, 3 times a week for 10 sessions of 5 minutes). , the group of neuro-gliding techniques (3 times a week for 10 sessions of 20 minutes) will be placed.
Main outcome variables
pain Severity of symptoms (paresthesia)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190618043934N23
Registration date: 2023-11-18, 1402/08/27
Registration timing: registered_while_recruiting

Last update: 2023-11-18, 1402/08/27
Update count: 0
Registration date
2023-11-18, 1402/08/27
Registrant information
Name
Zabihullah Mohaghegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3232 3232
Email address
oabstudent@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of ultrasound therapy and nerve gliding techniques in patients with mild to moderate carpal tunnel syndrome
Public title
Evaluation of the effect of ultrasound therapy and nerve gliding techniques in patients with mild to moderate carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having carpal tunnel syndrome based on clinical findings or electrodiagnostic criteria Not needing surgery and having mild to moderate disease symptoms based on muscle nerve strip and clinical examinations Not taking non-steroidal anti-inflammatory drugs or steroids before or during the intervention Balanced mental state and full satisfaction to participate in the research
Exclusion criteria:
Patients under 18 years of age Pregnant women Report of previous treatment of syndrome with ultrasound or laser or regular use of analgesic and anti-inflammatory drugs Use of local steroid injections inside the carpal tunnel during the last year or during the study Severe atrophy of the thenar region History of malignant tumors Having neuropathy of the peripheral system Having any disease that affects the results of the study Irregular attendance at treatment programs Unwillingness to participate in the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Placement of people in each group will be simple random and in a block method, in one of the two group A, ultrasound therapy (with a frequency of 1 Mhtz, current intensity of 1 wt/cm2) 3 times a week for 10 sessions and Each session for 5 minutes), group B will receive neuro-gliding techniques (3 times a week for 10 sessions and each session for 20 minutes). In this way, first, various blocks of four (AABB, BBAA, ABAB, BABA, ABBA and BABA) are created on different cards. One of these blocks will be randomly selected using the lottery method and the patients will be divided into one of two groups A or B. Then randomization is done for other patients as well. This will be done by the study manager.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome evaluator: The physical medicine specialist examines and records the desired variables without knowing the placement of patients in two groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717811674
Approval date
2022-09-26, 1401/07/04
Ethics committee reference number
IR.BUMS.REC.1401.248

Health conditions studied

1

Description of health condition studied
Carpal tunnel syndrome
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome

Primary outcomes

1

Description
Pain
Timepoint
At the beginning of the study and 4 weeks after the intervention in patients
Method of measurement
Using the visual pain scale questionnaire (VAS)

2

Description
Severity of symptoms (paresthesia)
Timepoint
At the beginning of the study and 4 weeks after the intervention in patients
Method of measurement
Using the Boston questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group 1 patients with carpal tunnel syndrome who are treated with ultrasound with a frequency of 1 megahertz, current intensity of 1 watt/cm2 3 times a week for 10 sessions and each session for 5 minutes.
Category
Treatment - Devices

2

Description
Intervention group: Intervention group 2 patients with carpal tunnel syndrome who will be treated with neuro-gliding techniques 3 times a week for 10 sessions and each session for 20 minutes.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital-Birjand
Full name of responsible person
Maryam Nazariyan
Street address
Taleghani Street
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
public_r@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Masoud Yosefi
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3238 1200
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaghegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Maryam Sadat Rahimi
Position
Faculty Membe
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Orthopedy, School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
maryam.sadat.rahimi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaghegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3232 3232
Email
zabihullahmohaghegh@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 need to publish individual patient information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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