Comparison of efficacy between two groups of dextrose injection of Prolotherapy and Methylprednisolone in CTS patients
Design
After giving the necessary explanations, a signed written consent is obtained from the mentioned patients, and then they are treated with Prolotherapy or Methyl prednisolone by block randomization method.
Settings and conduct
This randomized clinical trial will be performed in Imam Reza Hospital in Tehran in 1400
Participants/Inclusion and exclusion criteria
Inclusion criteria included age 20 to 80 years, patient informed consent and willingness to participate in the study,EMG NCV findings indicate mild to moderate CTS and They have symptom lasted more than three months and the diagnosis has been confirmed by electrodiagnostic examiners.
Intervention groups
Patients were randomly selected (one in between) in one of two groups treated with perinural D5W injection
Or methylprednisolone topically. In the first group, under one injection with 5 cc D5W and In the second group, they are injected with 1 cc of methylprednisolone and 0.5 cc of lidocaine in the carpal tunnel area. After injection, they are treated with COCK UP splint.
Main outcome variables
Evaluation of patient performance with Boston questionnaire؛ Intensity of pain ؛ Electrodiagnostic criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039323N3
Registration date:2021-11-27, 1400/09/06
Registration timing:prospective
Last update:2021-11-27, 1400/09/06
Update count:0
Registration date
2021-11-27, 1400/09/06
Registrant information
Name
Zahra Rezasoltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4382 3476
Email address
z.rezasoltani@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-16, 1400/09/25
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of neurofascial dextrose prolotherapy on pain and function of patients with carpal tunnel syndrome
Public title
The effect of dextrose and corticosteroid injections in CTS patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Nocturnal paresthesia / dysplasia with or without excessive pain on the hands
Numbness In the sensory distribution of the median nerve
Weakness with atrophic changes in the Median nerve innervated
Positive Phalen or Tinel test
Age 20 to 80 years
They have mild to moderate CTS and their symptoms last for more than three months And have been resistant to drug therapy and splints
conscious patient satisfaction
Exclusion criteria:
History of polyneuropathy
History of inflammatory arthritis
Current use of warfarin
Previous steroid injection for CTS
Trauma at the injection site
Allergy to corticosteroid
skin infection at the injection site
neoplasm at the injection site
History of Brachial plexiopathy
History of thoracic outlet syndrome
History of wrist surgery
History of hypothyroidism
History of pregnancy
History of rheumatic disorders
History of having a pacemaker
Age
From 20 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to Prolotherapy or Corticosteroid by block randomization in one of two groups. To randomly assign two groups with 22participants in each group (44 patients in total), we use block randomization with different block sizes. The size of the blocks is a multiple of 2 and a divisor of 44 (2,4,8). Initially, the size of the blocks is randomly selected. Then for each block, different permutations are determined for the size of the equal group. Finally, one of the permutations is randomly selected. Random numbers are generated using a computer in an independent statistical unit.
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
Ethics Committees of AJA University of Medical Sciences