Protocol summary

Summary
The objective of this randomized trial is to evaluate the effect of dry needling of supraspinatus muscle on the management of patients with impingement syndrome. In this study 15 subjects with subacromial impingement syndrome who suffer from shoulder pain 1-week before intervention and have localized pain at the proximal and antero-lateral aspect of shoulder joint and have at least one positive impingement test will be recruited and randomly assigned into intervention or control group. The subjects in the intervention group will receive one session of dry needling. The subjects in control group will receive no intervention. Changes of the average pain score, range of motion, and upper extremity performance improvement in the patients, will be measured before the intervention and after session, and will be compared between 2 groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201601234203N10
Registration date: 2016-03-02, 1394/12/12
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-03-02, 1394/12/12
Registrant information
Name
Atefeh Aminian Far
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4180
Email address
aminianfar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of dry needling of supraspinatus muscle on the management of patients with impingement syndrome
Public title
Dry needling and shoulder impingement syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who suffer from shoulder painat the proximal and antero-lateral aspect of shoulder region lasting more than 1-week; Having at least one positive impingement test. Exclusion criteria: Fibromyalgia; Pregnancy; Traumatic onset of symptoms; Other histoy of shoulder injury; Torn tendons; Ligamentous laxity; Numbness or tingling in the upper extremity; History of shoulder or neck surgery; Systemic diseases; BMI > 28; History of steroid injection 3 months before intervention; History of physiotherapy 6 months before intervention; Depression; Taking analgesics or muscle relaxants 72 hours befor examination; Complete tear of rotator cuff muscles diagnosed with ultrasonography; Frozen shoulder. Frozen shoulder
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization through sealed envelope

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Bassij Blvd, Semnan University of Medical Sciences, Deputy of Research, Semnan, Iran.
City
Semnan
Postal code
Approval date
2016-01-05, 1394/10/15
Ethics committee reference number
ir.semums.rec.1394.130

Health conditions studied

1

Description of health condition studied
Impingement syndrome of shoulder
ICD-10 code
M75.4
ICD-10 code description
Impingement syndrome of shoulder

Primary outcomes

1

Description
Pain
Timepoint
Before intervention, Immediately after intervention, 10 days after intervention
Method of measurement
VAS

2

Description
Shoulder range of motion
Timepoint
befor intervention, Immediately after intervention, 10 days after intervention
Method of measurement
Goniometery

3

Description
Shoulder function
Timepoint
befor intervention-10 days after intervention
Method of measurement
Shoulder performance questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: No intervention
Category
Treatment - Drugs

2

Description
Intervention group: Inserting of dry needling into trigger point of supraspinatus muscle with a 0.2 mm diameter and 4 mm length needle, lasting for 2 minutes.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabatabaee Clinic of Semnan University of Medical Sciences
Full name of responsible person
Dr Atefeh Aminian Far
Street address
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Dr, Ali Rashidipour
Street address
Bassij Blvd, Semnan University of Medical Sciences, Deputy of Research, Semnan, Iran.
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research, Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
aminfar@semums.ac.iraminfar83@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
aminfar@semums.ac.iraminfar83@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Position
Ph.D of Physiotherapy/ Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
aminfar@sem-ums.ac.iraminfar83@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...