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Comparison of the effect of hydrodissection combined with corticosteroids and open surgery in the treatment of moderate and severe carpal tunnel syndrome: A controlled clinical trial

Protocol summary

Study aim
Comparison of the effectiveness of hydrodissection combined with corticosteroids and open surgery in the treatment of moderate and severe carpal tunnel syndrome.
Design
Clinical trial, with two parallel groups, non-randomized, without blinding, on 40 patients
Settings and conduct
Patients with moderate to severe carpal tunnel syndrome who refer to physical medicine and rehabilitation or orthopedic clinics under the supervision of Isfahan University of Medical Sciences will be allocated to the surgery group if they wish to undergo surgery, and to the hydrodissection group if they do not agree to surgery or want to delay it for at least 6 months. In this study, only the data analyst is unaware of the patient grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Moderate to severe carpal tunnel syndrome, age over 18, no injection treatment or physiotherapy and modality within the last three months. Exclusion criteria: Radiculopathy, plexopathy, peripheral neuropathy, uncontrolled systemic diseases.
Intervention groups
The first group received median nerve release through hydrodissection, utilizing 5 cc of 5% dextrose solution and 1 cc of triamcinolone, guided by ultrasound in a single session. Meanwhile, the second group was treated surgically with a longitudinal incision on the distal forearm along the fourth finger.
Main outcome variables
Visual analogue scale score, Boston carpal tunnel questionnaire score for pain and function, amplitude and latency of median nerve sensory and motor responses

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180507039571N5
Registration date: 2025-03-26, 1404/01/06
Registration timing: prospective

Last update: 2025-03-26, 1404/01/06
Update count: 0
Registration date
2025-03-26, 1404/01/06
Registrant information
Name
Shervin Ghaffari hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3611 5208
Email address
shghaffari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-22, 1404/03/01
Expected recruitment end date
2026-01-20, 1404/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of hydrodissection combined with corticosteroids and open surgery in the treatment of moderate and severe carpal tunnel syndrome: A controlled clinical trial
Public title
Comparison of the effect of hydrodissection combined with corticosteroids and open surgery in the treatment of moderate and severe carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with moderate to severe Carpal tunnel syndrome based on electrodiagnostic testing Age above 18 Male and female gender Not receiving carpal tunnel injection treatment and physiotherapy and modalities in the last three months
Exclusion criteria:
Radiculopathy Plexopathy Motor neuron disease Peripheral neuropathy pregnancy Hand and bone joint deformity History of hand trauma Having uncontrolled systemic diseases, such as inflammatory joint diseases and uncontrolled diabetes Suffering from thenar atrophy and severe weakness of the palm muscles
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of school of medicine, Isfahan University of Medical Sciences
Street address
Vice President for Research and Technology, Building No. 4, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2025-03-10, 1403/12/20
Ethics committee reference number
IR.MUI.MED.REC.1403.506

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
Wrist pain score in carpal tunnel syndrome patients
Timepoint
Before the intervention and one, three, and six months after the completion of the intervention
Method of measurement
Using a visual analogue scale

2

Description
Severity of dysfunction
Timepoint
Before the intervention and one, three, and six months after the completion of the intervention
Method of measurement
Using the Boston carpal tunnel questionnaire (BCTQ)

3

Description
Sensory and motor wave amplitude of the median nerve
Timepoint
Before and three months after the intervention
Method of measurement
Electrodiagnostic study

4

Description
Median nerve sensory and motor wave latency
Timepoint
Before and three months after the intervention
Method of measurement
Electrodiagnostic study

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Using an ultrasound device (ALPINION E-CUBE9 with 3-12 Mhz linear probe.ALPINION medical system.Seoul.South Korea), a hydrodissection injection of 5 cc of 5% dextrose water and 1 cc of triamcinolone is administered without local anesthesia using an inplane approach from the ulnar side to release the median nerve from the surrounding tissue.
Category
Treatment - Drugs

2

Description
Intervention group 2: Median nerve release surgery is performed with a 2.5 cm long incision 1.5 cm distal to the forearm along the fourth finger.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Shervin Ghaffari Hoseini
Street address
Amin hospital, Sonbolestan Alley, Ibn Sina Avenue, Shohada Square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3445 5051
Email
shghaffari@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholam Reza Askari
Street address
3rd floor, Vice President for Research and Technology of the University, 4th building, Isfahan University of Medical Sciences, Hezar Jarib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3133
Email
intres@nui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Shervin Ghaffari Hoseini
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Isfahan Cardiovascular Research Institute, Shahid Rahmani Alley, next to Shahid Chamran Heart Hospital, after Shahrestan Bridge, 3rd Mushtaq St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3611 5208
Email
shghaffari@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shervin Ghaffari Hoseini
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Isfahan Cardiovascular Research Institute, Shahid Rahmani Alley, next to Shahid Chamran Heart Hospital, after Shahrestan Bridge, 3rd Mushtaq St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3611 5208
Email
shghaffari@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shervin Ghaffari Hoseini
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Isfahan Cardiovascular Research Institute, Shahid Rahmani Alley, next to Shahid Chamran Heart Hospital, after Shahrestan Bridge, 3rd Mushtaq St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3611 5208
Email
shghaffari@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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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