The effect of high intensity laser on rotator cuff tendonitis will be investigated.
Design
Clinical trial of 32 participants with control group, with parallel groups, double blind, randomized block.
Settings and conduct
Thirty-two patients with rotator cuff tendonitis will be referred to a physiotherapy clinic and will receive physiotherapy services within 12 sessions depending on the control group or treatment by a physiotherapist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of rotator cuff tendonitis based on clinical examination; movement restriction; pain more than 1 month with visual analog scale 3-7; evidence of subacromial fluid accumulation around the tendon; age range 20-60 years old.
Exclusion criteria: history of shoulder surgery; neoplastic disease; systemic inflammatory diseases; full rotator cuff tendon rupture based on ultrasound evidence; history of corticosteroid injection over the past 6 months.
Intervention groups
Thirty-two patients in the study will be divided into two groups of 16 in each treatment and control group.
Both treatment and control groups will receive 1 tablet of diclofenac 100 mg daily for the first 10 days after tendon rotator cuff rotation diagnosis. Hot packs in tendonitis area and pulsed ultrasound will be used in internal shoulder rotation.
In the treatment group, in addition to the conventional physiotherapy mentioned in the control group, a pulsed 808 nano meter pulse laser with a mean power of 4 watts will be used.
Both groups ROM training, including WAND exercises and strengthening the rotator cuff muscles of pain-free range.
Ultrasound evaluation of the rotator cuff tendon in both treatment and control groups will be performed.
Main outcome variables
The effect of high power laser on increasing range of motion; reducing pain; decreasing subacromial fluid around the tendon; returning to daily activity.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191127045528N1
Registration date:2020-02-23, 1398/12/04
Registration timing:registered_while_recruiting
Last update:2020-02-23, 1398/12/04
Update count:0
Registration date
2020-02-23, 1398/12/04
Registrant information
Name
morteza beyrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3235 6488
Email address
morteza.beyrami.pt@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-12, 1398/09/21
Expected recruitment end date
2020-12-11, 1399/09/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of high intensity laser therapy on clinical and sonogeraphy findings in patients with rotator cuff tendinitis
Public title
Effects of high intensity laser therapy on rotator cuff tendinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis for rotator cuff tendinitis
Range of motion restriction
Pain range 3-7 in visual analog scale
Increase liquid in subacromial space
Age between 20-60 years old
Exclusion criteria:
Shoulder surgery
Neoplastic disease
systemic inflammation disease
Complate tearing of rotator cuff
Cervical discopathy
Corticosteroids injection
Shoulder fracture
physical therapy in shoulder
Axillary lymphoedem
Myofasica syndrom
Pain killer user
Diabetic disease
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
32 patients will be selected by simple non-probability sampling.
After completing the informed consent form, the research will be randomly blocked with forth blocked size will be divided into two groups of 16; treatment and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be empowered with placebo without the knowledge of a kind of powerful laser.The respected colleague evaluates in which group, without knowing the people in the group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tabriz university of medical sciences
Street address
Third Floor Vice Chancellor for Research and Technology, Building No. 2, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5147746734
Approval date
2019-11-12, 1398/08/21
Ethics committee reference number
IR.TBZMED.REC.1398.837
Health conditions studied
1
Description of health condition studied
People with rotator cuff tendinitis
ICD-10 code
M75.1
ICD-10 code description
Rotator cuff syndrome
Primary outcomes
1
Description
Effects of high intensity laser therapy in increasing of shoulder range of motion.
Timepoint
Measurement of shoulder range of motion in the first study and after 12 sessions of laser therapy
Method of measurement
Goniometry
2
Description
The effect of high power laser on pain relief in people with shoulder tendonitis will be determined.
Timepoint
Measurement of shoulder pain in the first study and after 12 sessions of laser therapy.
Method of measurement
Visual Analogue Scale
3
Description
The effect of high power laser on decreasing sub acromial fluid around the tendon in people with rotator cuff tendonitis will be determined based on ultrasound images.
Timepoint
Measurement of subacromial fluid around the tendon in the first study and after 12 sessions of laser therapy.
Method of measurement
Musculoskeletal ultrasound
4
Description
The effect of a powerful laser on returning to the daily activities of people with shoulder tendonitis will be determined.
Timepoint
Return to daily activity at baseline and after 12 sessions of laser therapy.
Method of measurement
Shoulder pain and disability questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
16 patients participating in the study who were selected by simple non-probability sampling. Before using the modalities, the pain scale with "VAS scale" and the degree of disability by the "Pain and Shoulder Disability Questionnaire" were administered to patients. The data will be evaluated. Also, the range of motion of the shoulder in the directions of flexion, abduction and external and internal rotation by "goniometry" and the amount of subacromial fluid accumulation around the rotator cuff tendon will be measured by "sonography" treatment groups will receive 1 tablet of diclofenac 100 mg daily for the first 10 days after rotator cuff tendonitis. After the 10 day treatment period, diclofenac will be administered.Intervention group: In addition to the conventional physiotherapy, the 808 nm pulsed laser pulse laser with an average power of 4 watts and a power density of 20 joule / cm2 and frequency of 20 Hz will be used at 10 painful points and ROM exercises including WAND exercises to increase range of motion,flexion, external rotation, abduction, internal rotation and pendular training in the first 6 sessions and rotator cuff muscles strengthening and scapular stabilizers in the final 6 sessions. No pain was given.Marinate will initially be trained in a 3 set of 10 sets at the clinic to evaluate the proper performance under the supervision of a physiotherapist. If pain is reported during each exercise, the exercise will be stopped and re-examined after a few sessions.These exercises will be performed once a day, with 3 sessions of 10 sessions per day as a home exercise. (12 sessions in total). At the end of physiotherapy sessions, pain and range of motion، Shoulder pain and disability questionnaireare measured by a physiotherapist who is unaware of the treatment and The amount of fluid accumulation around the tendon will also be monitored by a physician.
Category
Rehabilitation
2
Description
Control group:16 patients participating in the study who were selected by simple non-probability sampling. Before using the modalities, the pain scale with "VAS scale" and the degree of disability by the "Pain and Shoulder Disability Questionnaire" were administered to patients. The data will be evaluated. Also, the range of motion of the shoulder in the directions of flexion, abduction and external and internal rotation by "goniometry" and the amount of subacromial fluid accumulation around the rotator cuff tendon will be measured by "sonography" control group will receive 1 tablet of diclofenac 100 mg daily for the first 10 days after rotator cuff tendonitis. After the 10 day treatment period, diclofenac will be administeredIn addition to the conventional physiotherapy,placebo high power laser therapy be used for them and ROM exercises including WAND exercises to increase range of motion flexion, external rotation, abduction, internal rotation and pendular training in the first 6 sessions and rotator cuff muscles strengthening and scapular stabilizers in the final 6 sessions. No pain was given.At the end of physiotherapy sessions, pain and range of motion، Shoulder pain and disability questionnaire are measured by a physiotherapist who is unaware of the control and The amount of fluid accumulation around the tendon will also be monitored by a physician.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sadra physiotherapy clinic
Full name of responsible person
Morteza Beyrami
Street address
No,5, jahan seyr building,saadi jonobi Ave,vali asr
City
Tabriz
Province
East Azarbaijan
Postal code
514777346
Phone
+98 41 3235 6488
Email
morteza.beyrami.pt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Aboulgasem Joyban
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht St.,Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
514777346
Phone
+98 41 3335 7311
Fax
+98 41 3334 4280
Email
info@medfac.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz university of medical science.
Proportion provided by this source
1
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
Tabriz University of Medical Sciences
Full name of responsible person
Morteza Beyrami
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Next to Imam Reza Hospital School of Medicine / Golgasht Street /Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
514777346
Phone
+98 41 3337 6923
Fax
Email
info@medfac.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Morteza Beyrami
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Next to Imam Reza Hospital School of Medicine / Golgasht Street /Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
514777346
Phone
+98 41 3337 6923
Fax
Email
info@medfac.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Morteza Beyrami
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Next to Imam Reza Hospital School of Medicine / Golgasht Street /Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
514777346
Phone
+98 41 3337 6923
Fax
Email
info@medfac.tbzmed.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
no more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
I can share treatment protocol and report completely.
When the data will become available and for how long
Start of access period 6 months after printing results