1. Determining and comparing the mean of pain in in subjects with adhesive capsulitis before, after five sessions, after ten sessions treatments and one month later
2. Determining and comparing the mean of abduction and external rotation in subjects with adhesive capsulitis before, after five sessions, after ten sessions treatments and one month later
3. Determining and comparing the mean of supraspinatous rest thickness in subjects with adhesive capsulitis before, after five sessions, after ten sessions treatments and one month later
4. Determining and comparing the mean of supraspinatous scaption 60 degree thickness in subjects with adhesive capsulitis before, after five sessions, after ten sessions treatments and one month later
Design
Randomized controlled clinical trial with factorial groups and double blinded
Settings and conduct
The rationale for this research is to determine the effects of laser therapy on pain, range of motion and muscle thickness in patients with adhesive capsulitis. This will done in poursina hospital and neither patients no examiner know the grouping and treatments procedures.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 16 to 60 years.
Adhesive capsulitis diagnosis: According to orthopedic physician assessment; Patients with pain duration between 3-9 month.
Exclusion criteria:
Patients with pain duration less than 3 months.
Patients with adhesive capsulitis which shoulder range of motion not affected.
Patients with humerus, clavicle and scapula fractures.
Patients with history of cervical and shoulder surgery, or capsular and tendon surgery.
Patients with complete soft tissues tear such as tendons and labrum.
Patients with referral pain form neck.
Addict or pregnant individuals.
Patients that took part in physiotherapy program about during four weeks ago.
Patients with history of rheumatoid diseases such as rheumatoid arthritis.
Patients with history of diabetes and other inflammatory, articular and myofascial diseases
Patients that laser therapy is contraindicated due to tumor or hemorrhage
Professional athletics
Intervention groups
Control group receive routine physical therapy treatments and intervention group receive routine physical therapy as well as laser therapy
Main outcome variables
Shoulder pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170516034003N2
Registration date:2018-02-01, 1396/11/12
Registration timing:prospective
Last update:2018-02-01, 1396/11/12
Update count:0
Registration date
2018-02-01, 1396/11/12
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
Expected recruitment start date
2018-02-19, 1396/11/30
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of laser therapy on pain, range of motion and muscle thickness in subjects with adhesive capslitis
Public title
The effects of laser therapy on pain and muscle thickness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adhesive capsulitis diagnosis: According to orthopedic physician assessment
Patients with pain duration between 3-9 month
Exclusion criteria:
Patients with adhesive capsulitis which shoulder range of motion not affected.
Patients with humerus, clavicle and scapula fractures
Patients with complete soft tissues tear such as tendons and labrum
Patients with history of diabetes and other inflammatory, articular and myofascial diseases
Patients that laser therapy is contraindicated due to tumor or hemorrhage
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were assigned simple randomly by randomized numerical table between 1 to52 numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients in both groups receive routine physiotherapy and laser therapy is performed in just one group. Treatment is done by health care staff who are not aware of the grouping and only implement the treatment protocol. The evaluation is done by one of the researchers who does not know about the treatment performed on patients.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
5th floor, Central office of Guilan University of Medical Sciences, Namjoo St., Rasht, Iran
City
Rasht
Province
Guilan
Postal code
۴۱۹۳۷۱۳۱۹۴
Approval date
2018-01-13, 1396/10/23
Ethics committee reference number
IR.GUMS.REC.1396.434
Health conditions studied
1
Description of health condition studied
Adhesive capsulitis
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder
Primary outcomes
1
Description
Visual Analogue Scale
Timepoint
Before intervention, After five sessions treatments, After ten sessions treatments, one month follow-up
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Shoulder range of motion with goniometer
Timepoint
Before intervention, After five sessions treatments, After ten sessions treatments, one month follow-up
Method of measurement
Goniometer
2
Description
Muscle thickness by sonography
Timepoint
Before intervention, After five sessions treatments, After ten sessions treatments, one month follow-up
Method of measurement
sonography
Intervention groups
1
Description
Intervention group: Interventions in this group include: 1) Infrared therapy for 20 minutes: The Infrared bulb is positioned at a distance of 50 cm from the shoulder of the individual. The patient will feel mild heat. 2- Treatment with TENS type brief for 20 minutes. In this method, four electrodes on the sides of the shoulder will be used. The frequency used varies from 3 to 120 Hz, and the patient will feel the electrical current, along with the muscle vibrations. 3- Exercise for strengthening muscle should include five exercises from the third to the tenth sessions twice daily. 4. Laser therapy: In this study, a laser with a wavelength of 905 nm, an energy density of 8 J / cm 2, a power of 50 mW in 10 points of the shoulder including 3 points on the anterior capsule, 3 points on the posterior capsule, 2 points on the root of the C5 nerve and the two points on the axillary region. The radiation time will be 91s for each point.
Category
Rehabilitation
2
Description
Control group: Interventions in this group include: 1) Infrared therapy for 20 minutes: The Infrared bulb is positioned at a distance of 50 cm from the shoulder of the individual. The patient will feel mild heat. 2- Treatment with TENS type brief for 20 minutes. In this method, four electrodes on the sides of the shoulder will be used. The frequency used varies from 3 to 120 Hz, and the patient will feel the electrical current, along with the muscle vibrations. 3- Exercise for strengthening muscle should include five exercises from the third to the tenth sessions twice daily.