Comparative evaluation of high intensity laser & extracorporeal shockwave therapy on pain , symptoms & electrodiagnostic parameters of patients with carpal tunnel syndrome
Determining the difference in the effect of high power laser treatment and extracorporeal shock waves on pain, symptoms and electrodiagnostic parameters of patients with carpal tunnel syndrome.
Design
It is a double-blind randomized clinical trial.
The sampling method is easy. Random division with Random Allocation Sampling method: available and patients with the desired criteria Randomization method: random sequence using www.randomization.com
Settings and conduct
outpatient clinics of Medical Sciences teaching hospitals After randomization, they are assigned to one of the two HILT and ESWT groups. All patients are advised to modify their lifestyle and use a wrist splint at night and use B1 300 mg tablets daily for one month. Patients were followed up in person before the intervention, the fourth week and the twelfth week.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with mild and moderate idiopathic CTS
Age over 18 years and under 60 years
Non-entry criteria: 1-Severe cases (absence of sensory or motor wave in the nerve strip test) 2-Cervical radiculopathy and 3-peripheral polyneuropathy such as diabetes and... 4-Active hand infection during visit 5-Finding a fixable underlying cause for CTS 6-Pregnancy 7-An underlying disease such as rheumatoid arthritis 8-Receiving painkillers and painkillers in the past 9-Injection test for treatment of CTS during the last 3 months 10-Presence of coagulation disorder
11-Using a heart pacemaker 12-Untreated or treated cancer
Intervention groups
intervention groups:
One group is subjected to high power laser and one group is subjected to shockwave treatment. Also, B1 300 drug and wrist band are prescribed for both groups.
Main outcome variables
visual analog scale [VAS], Boston questionnaire, distal sensory latency parameters - Across canal Sensory conduction velocity and distal motoric latency in EMG-NCV.
General information
Reason for update
Acronym
CTS/HILT/ESWT
IRCT registration information
IRCT registration number:IRCT20240317061317N1
Registration date:2024-04-18, 1403/01/30
Registration timing:registered_while_recruiting
Last update:2024-04-18, 1403/01/30
Update count:0
Registration date
2024-04-18, 1403/01/30
Registrant information
Name
mahdi Dastanpoor hossein abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3452 7933
Email address
mahdi.dastanpoor70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of high intensity laser & extracorporeal shockwave therapy on pain , symptoms & electrodiagnostic parameters of patients with carpal tunnel syndrome
Public title
Investigating the therapeutic effect of laser and shockwave on carpal tunnel syndrome or wrist nerve adhesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild and moderate idiopathic CTS
Age above 18 years and less than 60 years
Absence of severe cases (absence of sensory or motor wave in the nerve strip test)
Absence of underlying disease such as rheumatoid arthritis
Absence of cervical radiculopathy and peripheral polyneuropathy such as diabetes and...
Exclusion criteria:
Active hand infection during visit
History of injection to treat CTS during the last 3 months
Using a heart pacemaker
pregnancy
Untreated or treated cancer
Receiving painkillers and painkillers during the past period
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method is used, and sampling will be done by the method of alternating blocks of 2 pieces. In this way, 10 blocks of 3 pieces and each block contains 3 letters from the letters A and B, including AAB-ABA-BBA-BAB-.. . will have. (two groups of 30) each patient is given a card randomly. The cards are in sealed envelopes and the technician takes the envelopes and hands them to the patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
The method of blinding is double-blind, only the first doctor who is responsible for the intervention knows the type of intervention. In order to blind the patient, one main intervention and one other group intervention are performed with the device turned off. Other people involved in the study, including the second doctor who is responsible for conducting the electrodiagnostic test (EMG-NCV), the person responsible for the follow-up of the patients, and the person responsible for analyzing the data are unaware of the placement of the patients in group A or B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق در پژوهش دانشگاه علوم پزشکی اصفهان
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Building No. 4, Research and Technology Vice-Chancellor
City
esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-03-14, 1402/12/24
Ethics committee reference number
IR.MUI.MED.REC.1402.473
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
The scale of two methods of laser and shock wave therapy on patient's pain
Timepoint
Before the start of the intervention - 4 and 12 weeks after the intervention.
Method of measurement
visual analogue scale
2
Description
Comparison of two methods of laser and shock wave therapy on motor and sensory latency of the distal.
Timepoint
Before the start of the intervention - 12 weeks after the intervention.
Method of measurement
EMG-NCV
Secondary outcomes
1
Description
Comparison of laser therapy and shock wave therapy on the severity of symptoms and functional status of carpal tunnel syndrome
Timepoint
Before the intervention - 4 and 12 weeks after the intervention
Method of measurement
Boston questionnaire
Intervention groups
1
Description
Intervention group: the group including taking B1 300 drug for one month and wristband for 3 months and performing laser therapy with HILT low fluence protocol (1.6 W- 8 J/cm2) BTL-6000 device, with a combination of wavelength 808 & 1064 nm for 36 seconds and 5 sessions in 2 weeks.
Category
Treatment - Devices
2
Description
Intervention group: the group including the use of B1 300 drug for one month and wristband for 3 months and performing ESWT shock wave therapy using the radial method and 1000 shock protocol of 0.05 mJ/mm2 and with a frequency of 5 Hz, for this group in three sessions in two week (at least one session per week).
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical Medicine Clinic of Isfahan University of Medical Sciences Hospitals