The purpose of adding a dry needle to eccentric exercises is to reduce the treatment time in the exercise program and achieve possible more effective treatment results and save time and money.
Design
Clinical trial with control group, with parallel group, single blinded, randomized based on random allocation rule, sample size= 40
Settings and conduct
1- Admission of patients with inclusion criteria
2- Dividing patients into two treatment groups
3- eight sessions of eccentric exercises and the other group, in addition to these exercises, is treated with a dry needle for 4 sessions.
4- At the beginning of the third session of the dry needle, the studied variables (except the questionnaires) are re-evaluated.
5- re-evaluate variables at the end
6 - At the end, after 72 hours, as fallow up, the said variables are re-evaluated to prevent the effect of dry needle Soreness on the evaluation results.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Patients with positive diagnostic tests
2- aged 50 to 70 years
3- patients with chronic symptoms (3 to 6 months after the onset of symptoms)
4- Grade 1 and 2 tendon sprain
Exclusion criteria:
1- Complete tendon rupture
2- Illiterate patients
3- Patients with cognitive problems
4- Patients with shoulder instability
5- History of cardiovascular disease
Intervention groups
The first group of patients receive dry needle treatment in addition to eccentric exercises. The patients of the second group are treated with eccentric exercises and dry needling as a placebo (in such a way that the needle sinks superficially and only to the patient's hypodermis) (control group).
Main outcome variables
Improves tendon injury and reduces pain; Save treatment time; Save on treatment costs; Low side effects of treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210112050016N1
Registration date:2021-02-02, 1399/11/14
Registration timing:prospective
Last update:2021-02-02, 1399/11/14
Update count:0
Registration date
2021-02-02, 1399/11/14
Registrant information
Name
Shiva Pourshafie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2296 3751
Email address
sh_pourshafie@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-03, 1399/11/15
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Eccentric Exercises acompany with and without Dry Needling Approches at the Patients with Chronic Rotator Cuff Tendinopathy
Public title
dry needling and exercise therapy in rotator cuff tendinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic rotator cuff tendinopathy that can approve with: X-Ray, MRI, US, doctor approval and exam tests( Neer Test and Hawkins-Kennedy Test)
Age between 50 to 70 year
Chronic diagnosis( at least 3 to 6 months after symptoms appearance)
Tendon sprain in grade 1 or 2 in empty can test and lift off test
Exclusion criteria:
Patients whom have complete rupture of the rotator cuff muscle tendon
Patients who are unable to read and write
Patients who have cognitive problems and do not understand what is being asked of them
Patients with instability (partial dislocation or dislocation) in the shoulder
Patients with history of cardiovascular disease
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In base of random allocation rule, First, the number of sample size (40) is written on small and similar papers, then the papers are folded so that the numbers inside it are not known and placed inside the bag for drawing.
Each patient randomly picks a piece of paper without replacement. Patients who pick up odd numbers are in the treatment group and patients who pick up even numbers are in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
patient in control group treat with eccentric exercise and placebo dry needling( needle will just go through the hypodermis)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No 15, east ladan, south golzar Ave. , sayad shirazi highway
City
Tehran
Province
Tehran
Postal code
1693939977
Approval date
2020-12-22, 1399/10/02
Ethics committee reference number
IR.TUMS.FNM.REC.1399.152
Health conditions studied
1
Description of health condition studied
Rotator cuff tendinopathy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain: Pain is an unpleasant sensation that is felt by an organism due to external or internal stimuli. There is usually no complete objective method for measuring pain, and most pain is assessed by mental methods. In this study, the amount of discomfort and pain in the shoulder and arm is measured by the VAS scale. Shoulder disability: Shoulder pain when resting or moving with limited mobility and function in the shoulder is referred to as disability. In this study, the amount of limitation and pain in movements and daily activities is measured with Quick DASH and SPADI scale and TFAST (Timed Functional Arm and Shoulder Test).
Timepoint
The beginning of the study, the third session of dry needle, the last session of treatment, 72 hours later
Method of measurement
VAS scale, quick DASH and SPADI questionnaire and TFAST functional test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: undergo eight sessions of eccentric exercises in such a way that in each session, three sets of abduction, internal rotation and external rotation exercises are performed eccentrically with 10 to 15 repetitions in each set; In addition, the exercises are treated with dry needles for 4 sessions in such a way that the dry needle is inserted in between sessions for patients.
Category
Treatment - Other
2
Description
Control group: 8 sessions of eccentric exercises and 4 sessions of dry needles as a placebo
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pishgam physiotherapy clinic
Full name of responsible person
Sharareh Zandi
Street address
Dolat Street, between Qanat and Kaveh intersections, Negin Complex
City
Tehran
Province
Tehran
Postal code
1693939977
Phone
+98 21 2259 4876
Email
shiva_porshafie@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Siamak Bashardoust
Street address
Enqelab St., Pich Shemiran, corner of Safi Alisha St., Faculty of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5132
Email
s_bashardoust@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Faculty of Rehabilitation of Tehran University of Medical Science
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
Tehran University of Medical Sciences
Full name of responsible person
Siamak Bashardoust Tajali
Position
Assistant profossor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Enghelab St., Pich Shemiran, Faculty of Rehabilitation, Tehran University of Medical Sciences, Department of Physiotherapy
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
s_bashardoust@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shiva Pourshafie
Position
Sudent
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No 15, east ladan, south golzar av., end of sayad shirazi highway
City
Tehran
Province
Tehran
Postal code
1693939977
Phone
+98 21 2296 3751
Email
shiva_porshafie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shiva Pourshafie
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No 15, east ladan Ave., south golzar Ave., shahid fakhrizade Street
City
Tehran
Province
Tehran
Postal code
1693939977
Phone
+98 21 2296 3751
Email
shiva_porshafie@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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data included VAS scale, answers to Quick DASH and SPADI questionnaires and TFAST test and degree of shoulder abduction
When the data will become available and for how long
Until the publication of the article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For approval in magazines
From where data/document is obtainable
Shiva Pourshafi and Dr. Siamak Bashardoost, Faculty of Rehabilitation, University of Tehran
What processes are involved for a request to access data/document