The dose response effects of low level and high power laser therapy on pain and electrophysiological parameters of median nerve in subjects with carpal tunnel syndrome
The purpose of this study is to investigate the effects of low level and high power lasers therapy on pain and electrophysiological parameters of the medial nerve in patients with carpal tunnel syndrome. The inclusion criteria are age range of 20 to 60 years old and moderate carpal tunnel syndrome based on electromyography findings. Exclusion criteria are mild or severe carpal tunnel syndrome based on electromyography findings as well as secondary neuropathy and history of head and neck surgery. The target population are people aged 20-60 years with moderate carpal tunnel syndrome who will be referred to medical centers of Guilan University of Medical Sciences in the second half of the year. The patients will be randomized into 5 groups and each will be treated for 5 sessions with low level or high-power laser, one group is a control group. The sample size for each group is 20 people and 100 totally . The main outcomes of this study are pain and electrophysiologic parameters of median nerve that will be measured before and 20 days after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017051634003N1
Registration date:2017-10-05, 1396/07/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-05, 1396/07/13
Registrant information
Name
Kamran Ezzati
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3369 0099
Email address
kamranezzati@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences, Deputy of research
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The dose response effects of low level and high power laser therapy on pain and electrophysiological parameters of median nerve in subjects with carpal tunnel syndrome
Public title
Laser in carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 20-60 years; Having moderate carpal tunnel syndrome based on electromyographic findings; involvement of sensory and motor fibers provided that no one is absent; sensory delay of more than 3.6 msec and motor delay more than 1/4 millisecond.
Exclusion criteria: Individuals with severe and mild carpal tunnel syndrome: In severe patients sensory and motor waveforms are absent, and there is a decrease in the amplitude of motor nerve and denervation in electromyography, but in the mild type, only the involvement of sensory fibers without the involvement of motor fibers is present and sensory delay of more than 3.6 ms and a motor delay less than 1.4 ms; people with secondary neuropathy, such as thyroid problems; people with neck and shoulder myopathy; myelopathy and torticollis; those with a history of neck and shoulder surgery and other areas of the body; people with cancer, infection, pain and pulmonary disease, HIV; people with substance abuse or taking corticosteroids; pregnant women; people who have been continuously did physiotherapy or exercise during the past two weeks; taking analgesic and inflammatory drugs one week before the evaluation; people with Mental and cognitive impairment as well as uncorrected visual impairment; patients with atrophy of ternar muscle.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The data collection method will be randomized clinical trials in 5 treatment groups. For this purpose, a questionnaire containing the information, height, weight, type of exercise, upper limb, were given to the subjects.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences, Deputy of research
Street address
Deputy of Research, Opposie to Azodi Stadium, Namjoo St, Rasht, Iran
City
Rasht
Postal code
Approval date
2017-03-04, 1395/12/14
Ethics committee reference number
Ir.Gums.rec.1395.371
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
Delay amp area CAMP- Motor & Sensory NCV
Timepoint
Before and after 20 days
Method of measurement
Nerve conduction velocity
Secondary outcomes
1
Description
Pain
Timepoint
Before and after 20 days
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group 1: Low level laser 50 mW, 8 J/cm2 on 10 points each point 19 seconds irradiation and 4 type exercises.
Category
Rehabilitation
2
Description
Intervention group 2: Low level laser 50 mW, 20 J/cm2 on 10 points each point 15 seconds irradiation and 4 type exercises.
Category
Rehabilitation
3
Description
Intervention group 3: High power laser 5W, 8 J/cm2 on 20 cm2, 64 seconds irradiation and 4 type exercises.
Category
Rehabilitation
4
Description
Intervention group 4: High power laser 5W, 20J/cm2 on 20 cm2, 160 seconds irradiation and 4 type exercises.
Category
Rehabilitation
5
Description
Control group: 4 type exercises: Wrist extension, stretching the hand on table while standing, open and closing fingers, stretching the hand with opposite one.