IRCT | Comparison of the efficacy of corticosteroid injection with and without ultrasound-guided in paraplegic spinal cord injury patients, below T6 neurologic level with rotator cuff tendinopathy in shoulder pain and function improvement.

Protocol summary

Study aim: Comparision of the efficacy of corticosteroid injection with and without ultrasound-guided in subacromial bursa in paraplegic spinal cord injury patients with rotator cuff tendinopathy in shoulder pain and function improvement.
Design: Two arm parallel group, randomised clinical trial with 15 patients in which group, blinded patient and outcome assessment.
Settings and conduct: Physical medicine & rehabilitation clinic in Tehran medical university 4 Block randomization method
Participants/Inclusion and exclusion criteria: Inclusion criteria: Paraplegic spinal cord injury patients below T6 neurologic level with rotator cuff tendinopathy Age between 20 to 60 years Shoulder pain & positive Neer test & Hawkins-Kennedy test VAS>4 Exclusion criteria: History of stroke, head trauma, rheumatoid arthritis, glenohumeral osteoarthritis, humeral or clavicle fracture, diabetes mellitus, infection, tumor, pregnancy,steroid sensitivity, coagulopathy subacromial injection over 8 weeks ago
Intervention groups: Patients devided in two groups:A & B. A:Control (subacromial anatomical landmarc injection) B:Intervention (subacromial Ultrasound guided injection)
Main outcome variables: Selection of the choice method in corticosteroid injection in rotator cuff tendinopathy

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20180928041163N1

Registration date: 2018-11-07, 1397/08/16

Registration timing: registered_while_recruiting

Last update: 2018-11-07, 1397/08/16

Update count: 0
Registration date: 2018-11-07, 1397/08/16

Registrant information: Name

Najmeh Bolandnazar

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 21 6119 2110

Email address

n-bolandnazar@razi.tums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2017-03-20, 1395/12/30
Expected recruitment end date: 2019-03-19, 1397/12/28
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of the efficacy of corticosteroid injection with and without ultrasound-guided in paraplegic spinal cord injury patients, below T6 neurologic level with rotator cuff tendinopathy in shoulder pain and function improvement.

Public title: The efficacy of sonography in corticosteroid injection in subacromial bursa in rotator cuff tendinopathy.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Paraplegic spinal cord injury patients below T6 neurologic level with rotator cuff tendinopathy Age between 20 to 60 years Shoulder pain & positive Neer test & Hawkins-Kennedy test VAS>4

Exclusion criteria:

History of stroke, head trauma, rheumatoid arthritis, glenohumeral osteoarthritis, humeral or clavicle fracture, diabetes mellitus, infection, tumor, pregnancy,steroid sensitivity, coagulopathy ِ subacromial injection over 8 weeks ago
Age: From 20 years old to 60 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Data analyser

Sample size

Target sample size: 30

More than 1 sample in each individual

Number of samples in each individual: 2

Both shoulders or just right shoulder or just left shoulder.

Randomization (investigator's opinion)

Randomized

Randomization description

4 block randomization with sealed paper

Blinding (investigator's opinion)

Single blinded

Blinding description

At the first we explain for all participants that in this study,corticostroid injected in subacromial bursa and this treatment helps to all of them but in the one group with and the other group without ultrasonograghy and partitheners just don not know that stay in wich group. partisheners according to four block randomization list stay in with & without sonography group and recived ID. Cheif researcher( Physiatrist) ,data collector,outcome evaluator oriented about ID content(with or without sonography), so the traial is single blind.

Placebo

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

Imam Khomeini Hospital, Keshavarz Blvd

City

Tehran

Province

Tehran

Postal code

1419733141
Approval date: 2018-01-03, 1396/10/13
Ethics committee reference number: IR.TUMS.IKHC.REC.1396.4129

Health conditions studied

1

Description of health condition studied: Rotatorcuff tendinopathy
ICD-10 code: M20-M25
ICD-10 code description: Other joint disorders

Primary outcomes

1

Description: Shoulder pain
Timepoint: Before intervention, after 2 weeks, after 2 months
Method of measurement: Visual Analogue Scale

2

Description: Shoulder function
Timepoint: Before intervention, after 2 weeks, after 2 months
Method of measurement: Constant score

Secondary outcomes

1

Description: Quality of life
Timepoint: Before intervention, after 2 weeks, after 2 months
Method of measurement: World Health Organization Quality of Life BREF Questionair

Intervention groups

1

Description: Intervention group: 1cc depomedrol (Belgium) with 2 cc lidocain ultrasound guided injection in subacromial bursa
Category: Treatment - Devices

2

Description: Control group: 1cc depomedrol (Belgium) with 2 cc lidocain blind injection in subacromial bursa
Category: Treatment - Devices

Recruitment centers

1

Recruitment center: Name of recruitment center

Imam Khomeini Hospital

Full name of responsible person

Najmeh Sadat Boland Nazar

Street address

Keshavarz Blvd, Imam Khomeini Hospital

City

Tehran

Province

Tehran

Postal code

1419733141

Phone

+98 21 6119 2110

Email

n-bolandnazar@razi.tums.ac.ir

1

Sponsor: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Reza Malekzadeh

Street address

Keshavarz Blvd,Imam Khomeini Hospital

City

Tehran

Province

Tehran

Postal code

1419733141

Phone

+98 21 6119 2110

Email

nchrd2017@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Tehran 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

Tehran University of Medical Sciences

Full name of responsible person

Najmeh Bolandnazar

Position

Resident

Latest degree

Specialist

Other areas of specialty/work

Physical Medicine

Street address

Imam Khomeini hospital, Keshavarz Blvd

City

Tehran

Province

Tehran

Postal code

1419733141

Phone

+98 21 6119 2110

Fax

Email

n-bolandnazar@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Najmeh Bolandnazar

Position

Resident

Latest degree

Specialist

Other areas of specialty/work

Physical Medicine

Street address

Imam Khomeini hospital, Keshavarz Blvd

City

Tehran

Province

Tehran

Postal code

1419733141

Phone

+98 21 6119 2110

Fax

Email

n-bolandnazar@razi.tums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Najmeh Bolandnazar

Position

Resident

Latest degree

Specialist

Other areas of specialty/work

Physical Medicine

Street address

Imam Khomeini hospital, Keshavarz Blvd

City

Tehran

Province

Tehran

Postal code

1419733141

Phone

+98 21 6119 2110

Fax

Email

n-bolandnazar@razi.tums.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: Not applicable
Data Dictionary: Not applicable

Comparison of the efficacy of corticosteroid injection with and without ultrasound-guided in paraplegic spinal cord injury patients, below T6 neurologic level with rotator cuff tendinopathy in shoulder pain and function improvement.