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Comparison of the effect of the two different methods of dry needling in patients with shoulder impingement syndrome

Protocol summary

Study aim
Comparison of the effect of two different methods of dry needling in patient with shoulder impingement syndrome
Design
A randomized controlled trial,2 parallel groups with a control group, single-blinded, design of 48 cases
Settings and conduct
Field of Study: The effect of different dry needles methods in patients with impingement syndrome. location: Faculty of Rehabilitation, Shiraz University of Medical sciences. method: Patients will be treated With routine physical therapy treatment. Finally, a statistical comparison of different needling methods in the 1st & 2nd groups will be performed. The data collector researcher will be unaware of the patient's classification.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged between 20 and 55, positive Hawkins-Kennedy and Neer's sig tests, existence of at least one trigger point in the infraspinatus muscle, matching the pattern of trigger points with patient pain, Exclusion criteria: History of shoulder injections, history of shoulder surgery, glenohumeral instability, history of physiotherapy in the past 3 months, signs of systemic disorders, use of corticosteroids drugs in the last 3 months, overhead sport & activity, and any restrictions on dry needling,
Intervention groups
1st intervention group (10 consecutive sessions of physiotherapy including interferential therapy, Hot packs and exercise therapy plus three sessions of dry needle infra-spinatus trigger points by deep methods) 2nd intervention group (10 consecutive sessions of physiotherapy including interferential therapy, Hot packs and exercise therapy plus three sessions of dry needle infra-spinatuos trigger points by Hong methods) 3.Control group (10 consecutive sessions of physiotherapy including interferential therapy, Hot packs and exercise therapy)
Main outcome variables
Shoulder Pain and Disability, pain Intensity, pressure pain threshold

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190409043210N1
Registration date: 2020-01-11, 1398/10/21
Registration timing: prospective

Last update: 2020-01-11, 1398/10/21
Update count: 0
Registration date
2020-01-11, 1398/10/21
Registrant information
Name
Mehrdad Emani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3832 6132
Email address
m_emani@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-04, 1398/11/15
Expected recruitment end date
2020-04-03, 1399/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of the two different methods of dry needling in patients with shoulder impingement syndrome
Public title
Dry needling of shoulder pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Impingement syndrome cases with positive Hawkins-kennedy and Neer’s sig presence of at least one active or inactive trigger point in the infraspinatus muscle matching Pattern of trigger points with patient pain based on references age between 20-55
Exclusion criteria:
Shoulder injection history shoulder surgery history glenohumeral instability Shoulder physiotherapy in the last 3 months Symptoms indicate systemic disorders Taking corticosteroid anti-inflammatory drugs over the past 3 months history of sport & over head activity Patients with any restrictions on dry needling
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
The way to assigning people to 3 groups based on the Permuted block randomization (6 people in every block) is according to Random Allocation software.
Blinding (investigator's opinion)
Single blinded
Blinding description
All stages of measurement and treatment will be performed by two researchers. The process of classification and treatment of patients will be performed by the first researcher. The second researcher will not be informed about the classification and interventions of patients and Will only collaborate on patient evaluation. Therefore, the blindness of the assessor will be performed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2019-03-18, 1397/12/27
Ethics committee reference number
IR.SUMS.REHAB.REC.1397.024

Health conditions studied

1

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

Primary outcomes

1

Description
Pain intensity
Timepoint
Before the intervention, at the end of tenth session, and four weeks after the last session of treatment
Method of measurement
Numeric pain rating scale

2

Description
Shoulder pain and disability
Timepoint
Before the intervention, at the end of tenth session, and four weeks after the last session of treatment
Method of measurement
Shoulder Pain and Disability Index

3

Description
Pressure pain threshold
Timepoint
Before the intervention, at the end of tenth session, and four weeks after the last session of treatment
Method of measurement
Digital pain pressure algometer (Wagner RS232)

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: Ten consecutive sessions of routine physical therapy for shoulder, including exercise and interferential therapy with hot pack and three sessions of deep dry needling for Infraspinatus muscle in the third, fifth and seventh session of the main therapy course.
Category
Rehabilitation

2

Description
second intervention group: Ten consecutive sessions of routine physical therapy for shoulder, including exercise and interferential therapy with hot pack and three sessions of dry needling by Hong method for Infraspinatus muscle in the third, fifth and seventh session of the main therapy course.
Category
Rehabilitation

3

Description
Control group: Ten consecutive sessions of routine physical therapy for shoulder, including exercise and interferential therapy with hot pack.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Clinic of shiraz rehabilitation Faculty
Full name of responsible person
Shohreh Taghizadeh
Street address
Abiwerdi one, Chamran street
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
rehabdep@sums.ac.ir
Web page address
http://rehab.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
Seventh floor, Central building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
http://research.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
Mehrdad Emani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Abywerdi 1, Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
m_emani@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shohreh Taghizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Abywerdi 1, Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
taghizsh@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehrdad Emani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Abywerdi 1, Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
m_emani@sums.ac.ir

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
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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