The aim of this study was to investigate the effect of dry needle on the subacromial space(SAS).
Design
The clinical trial has two non-randomized and parallel groups of intervention and control with 3 months follow-up and designed for 30 samples which are entered into each of the intervention or control groups one by one according to the order of entering the research.
Settings and conduct
The research is being done in Tehran at Raz physiotherapy clinic and Mehregan radiology institute. Samples are selected from clients who are eligible to enter the research and have the willingness to participate. The study is single-blind and the colleague who measures the subacromial shoulder-distance by ultrasound before and after the intervention does not know about grouping.
Participants/Inclusion and exclusion criteria
People with subacromial shoulder pain syndrome referred to Raz Physiotherapy Center in 2021-2022 except for those with heart problems, injuries such as fractures, dislocations or trauma
Intervention groups
The intervention includes performing physical therapy on the painful shoulder. In the intervention group, dry needling is added to this treatment and at the end of the session, a dry needle is applied to the scapular levator muscles, rhomboids, as well as the active trigger points found in the first, third, fifth, seventh, and ninth sessions.
The Effect of Dry Needle Intervention on AcromioHumeral Distance and Shoulder Pain and Disability in Patient with Subacromial Pain Syndrome.
Public title
The Effect of Dry Needling on Shoulder Pain and AcromioHumeral Distance
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People with subacromial shoulder pain syndrome
Decreased subacromial space
Exclusion criteria:
History of fractures and dislocations in the scapula and shoulder area
History of scapula and shoulder surgery
Neurological symptoms in the upper extremities such as sensory and motor disorders
Frozen shoulder and severe neck pain
Congenital skeletal abnormalities
Inflammatory joint disease such as rheumatoid arthritis
Performing treatments such as dry needling, topical corticosteroids injection, PRP and ozone therapy during the last 3 months
Fear of needles and taking Anticoagulant for dry needle group
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Ethic Committee of University of Social Welfare and Rehabilitation Science
Street address
No. 18, Shafagh Alley, Hajizadeh St. West Payambar St., Dist.5
City
Tehran
Province
Tehran
Postal code
1471755486
Approval date
2021-06-19, 1400/03/29
Ethics committee reference number
IR.USWR.REC.1400.062
Health conditions studied
1
Description of health condition studied
Shoulder Subacromial Pain Syndrome
ICD-10 code
M25.51
ICD-10 code description
Pain in shoulder
Primary outcomes
1
Description
shoulder pain
Timepoint
Before the intervention, after the end of the intervention and 3 months after the end of the intervention
Method of measurement
Visual Analogue Scale
2
Description
Shoulder disability
Timepoint
Before the intervention, after the end of the intervention and 3 months after the end of the intervention
Method of measurement
Shoulder Pain And Disability Index
3
Description
Upper extremity disability
Timepoint
Before the intervention, after the end of the intervention and 3 months after the end of the intervention
Method of measurement
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash).
4
Description
Acromiohumeral Distance
Timepoint
Before the intervention, after the end of the intervention and 3 months after the end of the intervention
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Physiotherapy is performed on the painful shoulder. Physiotherapy treatment modalities include TENS, Ultrasound, and Infrared radiation. These devices include TENS Model 62L and Ultrasound Model 215A provided by Novin Medical Engineering Company. Passive, active and resistance exercises are performed for 25 minutes to increase range of motion, reduce pain and strengthen of the Serratus Anterior, Lower and Middle Trapezius, Pectoralis Major, Latissimus Dorsi, Teres Major, Deltoid, Supraspinatus, Infraspinatus, Teres Minor muscles.
Category
Rehabilitation
2
Description
Intervention group: In the intervention group, dry needling is added to physiotherapy treatment and at the end of the physiotherapy session, dry needling intervention is applied to the Levator Scapula muscles, Rhomboids as well as active trigger points found in the first, third, fifth, seventh and ninth sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Raz Physiotherapy institute
Full name of responsible person
Jamshid Mohammadiasl
Street address
No. 18, Shafaq Alley, Hajizadeh St., West Payambar St., District 5
City
Tehran
Province
Tehran
Postal code
1471755741
Phone
+98 21 4403 6121
Email
mohammadi_pt@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. Hamidreza Khoramkhorshid
Street address
Kodakyar Alley., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2822
Email
rd@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Jamshid Mohammadiasl
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 18, Shafagh Avenue, hajizadeh St., East Payambar St., Dist.5, Tehran
City
Tehran
Province
Tehran
Postal code
1471755741
Phone
+98 21 4497 4770
Fax
Email
mohammadi_pt@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Jamshid Mohammadiasl
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 18, Shafagh Avenue, hajizadeh St., East Payambar St., Dist.5, Tehran
City
Tehran
Province
Tehran
Postal code
1471755741
Phone
+98 21 4497 4770
Fax
Email
mohammadi_pt@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Jamshid Mohammadiasl
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 18, Shafagh Avenue, hajizadeh St., East Payambar St., Dist.5, Tehran
City
Tehran
Province
Tehran
Postal code
1471755741
Phone
+98 21 4497 4770
Fax
Email
mohammadi_pt@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as information about the main outcome, can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Scientific research
From where data/document is obtainable
mohammadi_pt@yahoo.com
What processes are involved for a request to access data/document