Protocol summary

Study aim
The aim of this study was to investigate the effect of rotator cuff dry needling on the stability and function of the upper limb in people with shoulder pain.
Design
A clinical trial with controlled group , single blind , randomized
Settings and conduct
In this clinical trial study, 40 patients with shoulder pain who referred to clinics affiliated to Shiraz School of Rehabilitation Sciences will be divided into two groups using a random method: the first group of dry needling and The second group receive sham dry needling.
Participants/Inclusion and exclusion criteria
This study are perform in people with shoulder pain who have had at least 3 months of pain and they have at least one active trigger point in two the muscle is made up of four rotator cuff muscles. And if they have special injury in the shoulder and neck joints or prohibited from using dry needling, they will be excluded from the study.
Intervention groups
Dry needling Group: People with shoulder pain who receive three sessions of dry needling in one week of treatment (every other day), in the trigger points of the rotator cuff muscles (supraspinatus, infraspinatus, subscapularis and teres minor). Control group: people with shoulder pain who receive the sham dry needling in the said muscles, in three sessions; They receive the same as the treatment group. Samples recruited from rehabilitation clinics of Shiraz University of Medical Sciences.
Main outcome variables
Shoulder stability and upper extremity function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190909044734N4
Registration date: 2023-08-20, 1402/05/29
Registration timing: prospective

Last update: 2023-08-20, 1402/05/29
Update count: 0
Registration date
2023-08-20, 1402/05/29
Registrant information
Name
Leila Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
leabbasi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-06, 1402/06/15
Expected recruitment end date
2023-10-07, 1402/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of rotator cuff trigger points dry needling on the stability and function of the upper limb in people with shoulder pain
Public title
Investigating the effect of dry needling of the rotator cuff muscles on the stability and function of the upper limb in people with shoulder pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of shoulder pain for at least three months Existence of trigger points with three characteristics: 1. Existence of a palpable knot in the skeletal muscle band.2. Existence of excessive points Irritable in taut band 3. Patients who report local or referred pain after mechanical stimulation of trigger points. (with the difference that latent trigger points become painful only after mechanical stimulation and active points even without stimulation. It is a mechanism that causes myofascial pain ) The presence of at least one trigger point in two of the four rotator cuff muscles
Exclusion criteria:
History of shoulder and neck surgery Instability of the glenohumeral joint and serious diseases related to the joint of cervical vertebrae, ang glenohumeral joint History of corticosteroid injections or local anesthetics in the past year Symptoms indicating systemic disorders History of any physiotherapy in the last 3 months History of diagnosis or medical reports about the presence of myopathy and neuropathy Cognitive problems Patients with any limitations in dry needling treatment (fear of needles, patient dissatisfaction, lymphoedema, Acute and emergency conditions, patients with coagulation problems, immune system disorders, vascular problems, diabetes, epilepsy, allergy to metals, patients with mental disorders, use of anticoagulants) Use of anti-platelet, anti-coagulant, anti-pain and anti-inflammatory drugs in the last three months Cardiovascular, rheumatoid, and neurological problems History of rotator cuff tears
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Using of randomization software, 40 numbers are considered for each case and the software defines 10 blocks of 4, from 4 to 2 people in the dry needling group and 2 people in sham dry needling. They are dried and thus 40 people are completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who will evaluate the patients and analyze the data is completely unaware of the details of the patient grouping and the treatments performed.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research, Shiraz Faculty of Rehabilitation Sciences
Street address
Abiverdi Street 1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
1733-71345
Approval date
2023-07-26, 1402/05/04
Ethics committee reference number
IR.SUMS.REHAB.REC.1402.009

Health conditions studied

1

Description of health condition studied
Shoulder pain
ICD-10 code
M25.51
ICD-10 code description
Pain in shoulder

Primary outcomes

1

Description
Stability of shoulder
Timepoint
Before the intervention, after the end of the treatment and one week after the end of the treatment as a follow-up
Method of measurement
Closed Kinetic Chain Upper Extremity Stability Test

2

Description
Upper extremity function
Timepoint
Before the intervention, after the end of the treatment and one week after the end of the treatment as a follow-up
Method of measurement
Quick Disabilities of Arm, Shoulder & Hand questionnaire

3

Description
Grip strenght
Timepoint
Before the intervention, after the end of the treatment and one week after the end of the treatment as a follow-up
Method of measurement
Dynamometer device

4

Description
Shoulder pain
Timepoint
Before the intervention, after the end of the treatment and one week after the end of the treatment as a follow-up
Method of measurement
Visual Analogue Scale

5

Description
The strength of internal and external rotators of the shoulder joint
Timepoint
Before the intervention, after the end of the treatment and one week after the end of the treatment as a follow-up
Method of measurement
Dynamometer device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: dry needling: people with shoulder pain who received 3 dry needling sessions per week according to the routine of the control group3 times during a week of treatment (one day in between), in the trigger points of the rotator cuff muscles (supraspinatus, infraspinatus, subscapularis and teres minor).
Category
Rehabilitation

2

Description
Control group: sham dry needling group: people with shoulder pain who received dry needling in the rotator cuff muscles (supraspinatus, infraspinatus, subscapularis and teres minor) and practically the needle does not enter the skin.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz School of Rehabilitation
Full name of responsible person
Leila Abbasi
Street address
Abivardi St 1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
1733-71345
Phone
+98 71 3627 1552
Fax
+98 71 3627 2495
Email
leabbasi@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Research Deputy, Central building of Shiraz University of Medical Sciences, Opposite Palestine St, Zand St.
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Fax
+98 71 3235 9317
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Leila Abbasi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty , Abiverdi 1 street , Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
leabbasi@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Abbasi
Position
استادیار دانشگاه علوم پزشکی شیراز
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Abiverdi St 1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
leabbasi@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Abbasi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Abiverdi St 1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
leabbasi@sums.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
No - There is not 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
No - There is not 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
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