Comparison of shockwave and low level laser in upper limb pain and function and ultra sonographic changes in bodybuilding sportsman with supraspinatus tendinitis
Comparison of a shockwave and low-level laser in upper limb pain and function and ultrasonographic changes in bodybuilding sportsman with supraspinatus tendinitis
Design
The clinical trial without a control group, with parallel groups, randomized, single-center. The sample size is 38 patients (consist of 2 groups of 19 intervention 1 and intervention 2).
Settings and conduct
Neuromuscular Rehabilitation Research Center.
Comparison of a shockwave and low-level laser in upper limb pain and function and ultrasonographic changes in bodybuilding sportsman with supraspinatus tendinitis will be performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Confirmation of supraspinatus tendon involvement by specialized tests; At least 3 months of pain in the affected area; No treatment of the affected area in the last 3 months.
Exclusion criteria: Malignancy, history of infection of the affected area, epilepsy; Cervical radiculopathy; Recurrent pain in the shoulder and neck.
Intervention groups
Intervention group 1: Therapeutic sessions for the low-level laser group; It is done 3 times a week for a month. the patient is placed in a sitting position. The laser is applied to focus on the points that have the most tenderness.
Intervention group 2: Therapeutic sessions for the shockwave group are 5 sessions per month (once every 6 days). the patient lies in a supine position and the shoulder is placed in extension and internal rotation with the elbow bent (hand behind the waist). Shockwave is then applied with gentle pressure.
Main outcome variables
Pain, Function.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N63
Registration date:2021-02-11, 1399/11/23
Registration timing:registered_while_recruiting
Last update:2021-02-11, 1399/11/23
Update count:0
Registration date
2021-02-11, 1399/11/23
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-03, 1399/11/15
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of shockwave and low level laser in upper limb pain and function and ultra sonographic changes in bodybuilding sportsman with supraspinatus tendinitis
Public title
Comparison of a shockwave and low-level laser in upper limb pain and function and ultrasonographic changes in bodybuilding sportsman with supraspinatus tendinitis
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of supraspinatus tendon involvement by specialized tests
At least 3 months of pain in the affected area
No treatment of the affected area in the last 3 months
Exclusion criteria:
Malignancy, history of infection of the affected area, epilepsy
Cervical radiculopathy
Recurrent pain in the shoulder and neck
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to the shockwave and low-level laser treatment groups by choosing a sealed envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2021-01-26, 1399/11/07
Ethics committee reference number
IR.SEMUMS.REC.1399.283
Health conditions studied
1
Description of health condition studied
Upper limb pain
ICD-10 code
G90.51
ICD-10 code description
Complex regional pain syndrome I of upper limb
Primary outcomes
1
Description
Pain
Timepoint
Before and after the intervention
Method of measurement
Visual analogue scale Questionnaire
2
Description
Function
Timepoint
Before and after the intervention
Method of measurement
Disability of Arm, Shoulder and Hand (DASH) Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Therapeutic sessions for the low-level laser group; It is done 3 times a week for a month. the patient is placed in a sitting position. The laser is applied to focus on the points that have the most tenderness.
Category
Treatment - Devices
2
Description
Intervention group 2: Therapeutic sessions for the shockwave group are 5 sessions per month (once every 6 days). the patient lies in a supine position and the shoulder is placed in extension and internal rotation with the elbow bent (hand behind the waist). Shockwave is then applied with gentle pressure.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Roghayeh Mohammadi
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences, Blvd Basij
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences, Blvd Basij
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences, Blvd Basij
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.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