The effect of high power laser and mirror therapy on complex regional pain syndrome type 1 in the hand area
Design
This study is a randomized, single-blind, placebo-controlled clinical trial. Available sampling method and patients are randomly divided into two groups depending on the high power laser and mirror therapy and Placebo laser and mirror therapy.
Settings and conduct
The patients in question attend the research center of Tarbiat Modarres University and then, after controlling the inclusion and exclusion criteria of the study, fill in the informed consent form for inclusion in the study. After initial clinical evaluations, they are divided into intervention and control groups. Clinical evaluations are performed again after the treatment sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: existence of complex regional pain syndrome in the hand; swelling in the affected hand; having persistent pain that is not commensurate with the cause of the accident.
Exclusion criteria: pregnancy; infection; patients with history of stroke; radiotherapy in the last 6 months.
Intervention groups
In this study, patients are divided into two groups of intervention and control. In the intervention group, first a high-power laser is shone on the hand area, then mirror therapy is performed as a range of motion exercises for the joints of the hand. In the control group, the high-power laser is performed as a placebo and then the mirror therapy is performed as a range of motion exercises for the joints of the hands.
Main outcome variables
Pain level; hand function level; range of motion; swelling level; muscle activity level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210724051966N1
Registration date:2022-02-07, 1400/11/18
Registration timing:prospective
Last update:2022-02-07, 1400/11/18
Update count:0
Registration date
2022-02-07, 1400/11/18
Registrant information
Name
Farhan Khorramdel
Name of organization / entity
The university of Tarbiat Modares
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 6544
Email address
farhan.khorramdel@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-06, 1400/12/15
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of high power laser and mirror therapy on type I complex regional pain syndrome in the hand area
Public title
Evaluation of the effects of high power laser and mirror therapy on type I complex regional pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis by a neurologist or orthopedist of a complex regional pain syndrome in the participant's hand
Men and women with type 1 complex regional pain syndrome based on the Budapest standard
The patient's hand is involved
Having constant pain that is not commensurate with the accident that caused it
There is edema or swelling in the hand relative to the healthy side
Exclusion criteria:
Pregnancy
Infection
Radiotherapy in the last 6 months
cancer
Patients with stroke
People's unwillingness to continue treatment for any reason
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly assigned to the study or control group by selecting one of the envelopes in the package
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, only participants in the study are blinded. In both groups, mirror therapy and laser therapy are performed, but in the control group, instead of laser, there is only red light.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat modares University
Street address
Tarbiat Modarres University, Jalal al Ahmad Ave., Nasr Bridge
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2021-12-26, 1400/10/05
Ethics committee reference number
IR.MODARES.REC.1400.260
Health conditions studied
1
Description of health condition studied
Complex regional pain syndrome
ICD-10 code
G90.5
ICD-10 code description
Complex regional pain syndrome I (CRPS I)
Primary outcomes
1
Description
Pain level changes
Timepoint
Measurement of pain at the beginning of the study (before the intervention) and at the end of treatment sessions (seven sessions and three sessions per week for a total of fourteen days after the intervention)
Method of measurement
Visual analogue scale
2
Description
Hand function changes
Timepoint
Measurement of changes in hand function at the beginning of the study (before the intervention) and at the end of treatment sessions (seven sessions and three sessions per week for a total of fourteen days after the intervention)
Method of measurement
Fugl-Meyer Evaluation Scale
3
Description
Hand swelling changes
Timepoint
Measurement of changes in hand swelling at the beginning of the study (before the intervention) and at the end of treatment sessions (seven sessions and three sessions per week for a total of fourteen days after the intervention)
Method of measurement
Measurement by Figure of eight method
4
Description
Range of motion
Timepoint
Measurement of range of motion at the beginning of the study (before the intervention) and at the end of the treatment sessions (seven sessions and three sessions per week for a total of fourteen days after the intervention)
Method of measurement
Goniameter
5
Description
The amount of muscle activity
Timepoint
Measurement of muscle activity at the beginning of the study (before the intervention) and at the end of the treatment sessions (seven sessions and three sessions per week for a total of fourteen days after the intervention)
Method of measurement
Electromyography device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: High-power laser with K-laser brand with a power of 5 watts with a dose of 20 joules per square centimeter and a cross-sectional area of 1 cm in 3 phases in the entire hand area. Seven sessions and 3 sessions per week of this intervention is performed. Then, mirror therapy is performed with Range of motion exercise of the hand joints.
Category
Treatment - Other
2
Description
Control group: Red light radiation is done in 3 phases and in the whole hand area. Seven sessions and 3 sessions per week of this intervention. Mirror therapy is then performed with Range of motion exercise of the hand joints.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The University of Tarbiat Modares
Full name of responsible person
Farhan Khorramdel
Street address
Tarbiat Modarres University, Jalal al Ahmad Ave., Nasr Bridge
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 3115
Email
farhan.khoramdel@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Tarbiat modares
Full name of responsible person
Yaghoob Fatolahi
Street address
Tarbiat Modarres University, Jalal al Ahmad Ave., Nasr Bridge
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3115
Email
farhan.khoramdel@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Tarbiat modares
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
The University of Tarbiat Modares
Full name of responsible person
Farhan Khorramdel
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat Modarres University, Jalal al Ahmad Ave., Nasr Bridge
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3115
Email
farhan.khoramdel@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Farhan Khorramdel
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat Modarres University, Jalal al Ahmad Ave., Nasr Bridge
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3115
Email
farhan.khoramdel@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Farhan Khorramdel
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat Modarres University, Jalal al Ahmad Ave., Nasr Bridge
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3115
Email
farhan.khoramdel@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