Determining and comparing the effectiveness of local corticosteroid injection and high-power laser therapy in patients with de Quervain’s tenosynovitis.
Design
Clinical trial with two parallel groups, bilaterally blind, randomized, phase 3 on 20 patients, random numbers table was used for randomization by block method.
Settings and conduct
The population investigated in this study consists of patients with the diagnosis of de Quervain’s tenosynovitis who have referred to the physical medicine clinic of Besat Hospital. Patients in group A will undergo high-power laser therapy. In this group, a gallium aluminum arsenide diode laser with a wavelength of 1064 nm, an output power of 8 watts, and an average energy intensity of 4 J/cm2 will be used. The laser wave is a pulse type with a frequency of 50 Hz and will be applied by scanning method. The total duration of treatment in each session will be 5-7 minutes. All patients will be treated for 3 consecutive weeks (5 sessions).Local corticosteroid injections will be performed for patients in group B. First, an ultrasound of the wrist is performed and the appropriate point for injection is marked. Then, under the sono guide, 1 ml of hydrocortisone and 1 ml of 2% lidocaine are injected at the site of the mark.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Duration of diagnosis is at least 3 months;Age 18-65 years;Minimum pain intensity according to VAS>3;
Exclusion Criteria:
History of surgery or recent wrist trauma;Vascular diseases;Corticosteroid treatment currently or within the past 4 months
Intervention groups
Patients in group A will undergo high-power laser therapy, 5 sessions of 5 minutes.
Patients in group B will be injected with 1 ml of hydrocortisone and 1 ml of 2% lidocaine.
Main outcome variables
tendon thickness, pain intensity, quality of life, patient satisfaction with treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221228056965N1
Registration date:2023-09-06, 1402/06/15
Registration timing:registered_while_recruiting
Last update:2023-09-06, 1402/06/15
Update count:0
Registration date
2023-09-06, 1402/06/15
Registrant information
Name
motahareh pourgholam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3323 6909
Email address
m.akbarikia@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of local corticosteroid injection and high-level laser therapy in patients diagnosed with de Quervain’s tenosynovitis.
Public title
Comparing the efficacy of laser and injection in de Quervain’s tenosynovitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosis of de Quervain’s tenosynovitis
Duration of diagnosis is at least 3 months
Age 18-65 years
Minimum pain intensity according to VAS>3.
Exclusion criteria:
History of recent wrist surgery or trauma
Vascular diseases
Corticosteroid treatment currently or within the past 4 months
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
We made 30 cards and write letter C on 15 for corticosteroid and on the other 15 letter L for the laser therapy group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the envelopes randomly will be selected and open it, based on selected letter ( C or L) patients will be assigned to local corticosteroid injection and high-level laser therapy
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor will be blinded to the treatment group of the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamedan University of Medical Sciences
Street address
Shahid Fahmideh St, Pazhouhesh
City
Hamedan
Province
Hamadan
Postal code
6517838736
Approval date
2022-12-03, 1401/09/12
Ethics committee reference number
IR.UMSHA.REC.1401.745
Health conditions studied
1
Description of health condition studied
de Quervain’s tenosynovitis
ICD-10 code
M65.4
ICD-10 code description
Radial styloid tenosynovitis [de Quervain]
Primary outcomes
1
Description
Changes in the intensity of pain in the wrist
Timepoint
On arrival, 4 weeks After the intervention, 12 weeks After the intervention
Method of measurement
visual analog scale
Secondary outcomes
1
Description
Quality of Life
Timepoint
On arrival, 4 weeks After the intervention, 12 weeks After the intervention
Method of measurement
12- item short form survay
Intervention groups
1
Description
"The first Intervention group": high-power laser therapy, in this group, a gallium aluminum arsenide diode laser with a wavelength of 1064 nm, an output power of 8 watts, and an average energy intensity of 4 joules per square centimeter will be used. The laser wave is a pulse type with a frequency of 50 Hz and will be applied by scanning method. The total duration of treatment in each session will be 5-7 minutes. All patients will be treated for 3 consecutive weeks (5 sessions).
Category
Rehabilitation
2
Description
The second Intervention group : "intervention group 2": For patients in this group , local injection of corticosteroids will be performed. First, an ultrasound of the wrist is performed and the appropriate point for injection is marked. Then, under the sono guide, 1 ml of hydrocortisone and 1 ml of 2% lidocaine are injected at the site of the mark.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan Besat Hospital
Full name of responsible person
Motahareh Pourgholam
Street address
Hokama St, Motahari Blvd
City
Hamedan
Province
Hamadan
Postal code
4541165148
Phone
+98 991 788 8751
Fax
+98 81 3265 1515
Email
motaharehpoorqolam@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Shokouhi
Street address
Fahmideh St, Pazhouhesh Sq
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3252 0182
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Motahareh Pourgholam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Hokama St, Besat Hospital
City
Hamedan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0033
Email
M.akbarikia@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Motahareh Pourgholam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Hokama St, Besat Hospital
City
Hamedan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0033
Email
M.akbarikia@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Motahareh Pourgholam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Hokama St, Besat Hospital
City
Hamedan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0033
Email
M.akbarikia@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