Protocol summary

Study aim
the effectiveness of Dry Needling with and without intramuscular electrical stimulation on pain and function in patients with impingement syndrome
Design
clinical randomised trial,parallel group with assessor blind
Settings and conduct
in this study patients with shoulder impingement syndrome who are reffered to the clinic of Shahid Beheshti University, are included and devided randomly to two groups. patients are assessed by a assessor who is blind to the intervention and then they undergo dry needling for trigger points on Upper Trapezius and Infra Spinatus muscle.
Participants/Inclusion and exclusion criteria
inclusion:patients diagnosed with impingement syndrome who have active trigger point in upper trapezius and infra spinatus muscle, age between 18-20, moderate intensity of pain based on VAS exclusion:having any musculoskeletal disorder or neurological disorder in neck or upper limb, patients who are afraid of needle, pregnancy
Intervention groups
intervention group 1 includes impingement syndrome patients receiving 1 minute of fast in-fast out dry needling on trigger point in upper trapezius and infraspinatus muscle. then the needle is remained in the trigger point for 10 minutes intervention group 2 includes impingement syndrome patients receiving dry needling with intramuscular electrical stimulation.dry needling is done like the other group for 1 minute.then the cathode electrode is attached to the needle with alligator clips and the anode electrode is placed on spinous process of C7. the electrical stimulation type is burst and will be set with a frequency of 2Hz and pulse duration 200µs and the intensity increase to elicit muscular contraction without pain. the stimulation is applied on each needle separately for 10 minutes.
Main outcome variables
it is expected that this technique will be effective on pain, pain pressure threshold, range of motion and shoulder function.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180410039256N1
Registration date: 2018-12-09, 1397/09/18
Registration timing: registered_while_recruiting

Last update: 2018-12-09, 1397/09/18
Update count: 0
Registration date
2018-12-09, 1397/09/18
Registrant information
Name
Sayena Vahidimanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1724
Email address
vahidimanesh1372@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-22, 1397/07/30
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study of the effects of a single session dry needling with and without intramuscular electrical stimulation on active trigger point in patients with shoulder impingement syndrome
Public title
study of the effects of dry needling with and without intramuscular electrical stimulation on shoulder pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with shoulder impingement syndrome who have 3 positive tests among neer, hawkins kennedy, jobe,external rotation resistance, painful arc age between 18 to 50 presence of active trigger points in upper trapezius and infraspinatus muscles moderate pain intensity of 3 baised on VAS
Exclusion criteria:
any postural disorders like scoliosis ect frozen shoulder any other musculoskeletal disease like myopathy, neck and shoulder surgery etc neurological disease malignancy absolute and relative contraindication use of dry needling for women being on period time
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
patients will be randomly divided to one of the two intervention groups. 15 cards are considered for each group. these cards are placed in sealed envelops and each patients will get one.
Blinding (investigator's opinion)
Single blinded
Blinding description
in this study the assessor is blind to the treatment the data analyser will be blind too
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of Shahid Beheshti University of Medical Scineces
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2018-03-17, 1396/12/26
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.1397

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
intensity of pain
Timepoint
before the intervention, immediately after the intervention, one week after treatment
Method of measurement
Visual Analogue Scale

2

Description
active shoulder range of motion
Timepoint
before the intervention, immediately after the intervention, one week after treatment
Method of measurement
Goniometery

3

Description
pain pressure threshold
Timepoint
before the intervention, immediately after the intervention, one week after treatment
Method of measurement
digital Algometer

Secondary outcomes

1

Description
disability of the arm, shoulder and hand
Timepoint
before the treatment, one week after treatment
Method of measurement
persian version of Disability of the Arm, Shoulder,Hand

Intervention groups

1

Description
Intervention group: dry needling
Category
Treatment - Other

2

Description
Intervention group: dry needling with intramuscular electrical stimulation
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti school of rehabilitation Sciences
Full name of responsible person
mohammad mohsen roostaei
Street address
SBMU School of Rehabilitation Sciences, Damavand St, Across from Bu Ali Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
tavan2020@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Bldg No.2, Shahid Arabi Ave, yaman St, Chamran Hwy
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sayena Vahidimanesh
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 20,Sa'ed Ave, Morvarid Ave,saadad abad Blvd,Tehran
City
Tehran
Province
Tehran
Postal code
1998747316
Phone
+98 21 2207 7747
Email
vahidimanesh1372@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
mohammad mohsen roostaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
SBMU School of Rehabilitation Sciences, Damavand St, Across from Bu Ali Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
roosta@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sayena Vahidimanesh
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
SBMU school of rehabilitation sciences, Damavand st, across from Bu Ali hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1724
Email
vahidimanesh1372@sbmu.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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