The aim of this study is to compare the effect of ultrasound guidance on accuracy and efficacy of intra-articular steroid injections for treatment of shoulder adhesive capsulitis. Inclusion criteria include shoulder pain in the past 4-12 weeks and limited active and passive movements of the shoulder joint and exclusion criteria include contrast media allergy, inflammatory or infectious diseases and dislocation or fracture of shoulder joint. 41 patients with shoulder pain referred to Modarres Hospital who are candidate for intra-articular steroid injection will be assessed in this study. Shoulder pain status, range of motion and joint function will be registered. Then patients will be divided into two groups: in one group, steroid and contrast media will be injected using ultrasound guidance and in control group these injections will be performed with examination of anatomical markers. Thereafter, accuracy of injections assessed by a radiologist using plain X-ray(based on whether contrast media is injected in intra-articular space or not) and efficacy of treatment investigated by measuring range of motion and evaluating shoulder function and pain reduction, 1 and 4 weeks after treatment. Accuracy and efficacy of injections will be compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022313442N7
Registration date:2016-04-19, 1395/01/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-19, 1395/01/31
Registrant information
Name
Seyed Ahmad Raeissadat
Name of organization / entity
Modares Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
a_raeissadat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-11-09, 1394/08/18
Expected recruitment end date
2016-03-18, 1394/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ultrasound guidance on accuracy and efficacy of intra-articular steroid injections for treatment of shoulder adhesive capsulitis.
Public title
effect of adding sonography in treatment of shoulder pains
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral Adhesive Capsulitis
Exclusion criteria:
Fracture; History of Shoulder Surgery; Steroid Hypersensetivity
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
41
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic commitee of faculty of medicine. Shahid Beheshti University of Medical Sciences
Street address
Kaj square, Saadat Abad street, Tehran
City
Tehran
Postal code
Approval date
2015-11-15, 1394/08/24
Ethics committee reference number
IR.SBMU.SMREC1394.99
Health conditions studied
1
Description of health condition studied
Adhesive Capsulitis of shoulder
ICD-10 code
M75.0
ICD-10 code description
adhesive capsulitis of shoulder
Primary outcomes
1
Description
pain
Timepoint
0 ,1 Week , 4Weeks
Method of measurement
VAS
Secondary outcomes
1
Description
Joint Function
Timepoint
0, 1 week, 4 weeks
Method of measurement
Oxford Questionaire
2
Description
ROM
Timepoint
0, 1 week, 4 weeks
Method of measurement
Goniometer
Intervention groups
1
Description
Solution of 1 cc Triamcinolon + 1 cc Lidocain 1% + 3.5 cc of non ionized contrast intra articular injection (sonographic guided vs blind)