Evaluation of the effect of the wristband with low-level laser therapy in comparison with wristband alone in reducing pain in patients with the wrist ganglion cyst
Determining the effect of low power laser on reducing pain caused by ganglion cysts of the wrist
Design
A randomized single-blinding clinical trial with the control group, with parallel groups, phase 3 on 60 patients
Settings and conduct
In this study, 60 patients with ganglion cysts of the wrist referred to Al-Zahra Hospital will be included in the study and will be randomly divided into two groups. Due to the intervention method, the study is single-blind. Both groups will receive wristbands. The intervention group is also treated with the low-level laser. In the control group, patients will be received a zero-watt laser in the same way. Patients' pain is assessed before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having wrist pain caused by the ganglion cyst and satisfaction to participate in the study. Exclusion criteria include intra-articular corticosteroid injection in the last 6 months, use of low-level laser therapy to treat cyst in the last 6 months, other joint disorders besides ganglion cyst, history of distal forearm and wrist fractures, having polyneuropathy and peripheral nerve involvement (Ulnar, Radial, Median), having rheumatic diseases, and have a history of recent trauma in the past two months.
Intervention groups
All patients use a wristband. In the intervention group, patients receive laser by "FLOWER" method as a point in the middle of the ganglion cyst with intensity of 10 J and 4 points around it with an intensity of 5 J by a 0.5 watt power device. In the control group, patients will receive a zero-watt laser in the same way.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120729010439N4
Registration date:2020-12-23, 1399/10/03
Registration timing:registered_while_recruiting
Last update:2020-12-23, 1399/10/03
Update count:0
Registration date
2020-12-23, 1399/10/03
Registrant information
Name
Babak Vahdatpour
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 5555
Email address
vahdatpour@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of the wristband with low-level laser therapy in comparison with wristband alone in reducing pain in patients with the wrist ganglion cyst
Public title
The effect of low level laser therapy in pain relief of patients with wrist ganglion cyst
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having wrist pain caused by the ganglion cyst
Satisfaction to participate in the study
Exclusion criteria:
Intra-articular corticosteroid injection in the last 6 months
Use of low-level laser therapy to treat cyst in the last 6 months
Other joint disorders besides ganglion cyst
History of distal forearm and wrist fractures
Having polyneuropathy and peripheral nerve involvement (Ulnar, Radial, Median)
Having rheumatic diseases
Have a history of recent trauma in the past two months
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
We randomly select 60 eligible patients. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the two study groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, due to the fact that the intervention group will be treated with low-level laser therapy and patients in the control group will be treated with zero watt laser therapy in the same way. Therefore, the researcher is aware of the type of therapeutic intervention, but the participant and the person evaluating the information will not be aware of the two groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Esfahan
Province
Isfehan
Postal code
8179964167
Approval date
2020-06-01, 1399/03/12
Ethics committee reference number
IR.MUI.MED.REC.1399.190
Health conditions studied
1
Description of health condition studied
Wrist ganglion cyst
ICD-10 code
M67.40
ICD-10 code description
Ganglion, unspecified site
Primary outcomes
1
Description
Pain score
Timepoint
Before, 4 and 8 weeks after the intervention
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All patients use a wristband. In the intervention group, patients receive laser by the "FLOWER" method as a point in the middle of the ganglion cyst with the intensity of 10 J and 4 points around it with the intensity of 5 J by a device with 0.5 watt power.
Category
Treatment - Other
2
Description
Control group: All patients use a wristband. In the control group, patients will be received a zero-watt laser in the same way as the intervention group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Babak Vahdatpour
Street address
Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
vahdatpour@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Babak Vahdatpour
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Rehabilitation Medicine, Alzahra Hospital, Soffeh blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
Vahdatpour@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Vahdatpour
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Rehabilitation Medicine, Alzahra Hospital, Soffeh blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Fax
+98 31 1668 7898
Email
vahdatpour@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Vahdatpour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Rehabilitation Medicine, Alzahra Hospital, Soffeh blvd.
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3668 5555
Fax
+98 31 1668 7898
Email
vahdatpour@med.mui.ac.ir
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