Comparison between therapeutic responses to ultrasound, low level LASER+ultrasound, sonographically guided extra and intra tendon's sheath corticosteroid injection in the treatment of long head of biceps tendinitis
(1) Objectives: Comparison between therapeutic responses to ultrasound, low level LASER+ultrasound, sonographically guided extra and intra tendon's sheath corticosteroid injection in the treatment of long head of biceps tendinitis. (2) Design: Randomized controlled trial. (3) Setting and conduct: Sample size of 144 patients will randomly assign into intervention ( low level LASER+ultrasound, sonographically guided extra and intra tendon's sheath corticosteroid injection) or control (ultrasound) group and will be treated in academic orthopedic hospital.(4) Participants: Inclusion criteria: Presence of pain in shoulder or upper extremity for more than 3 months; Point tenderness in bicipital groove; At least one positive biceps tendon test; No partial or complete rotator cuff tear. Exclusion criteria: History of shoulder surgery or injection; Calcification in rotator cuff; Dislocation, subluxation, partial or complete tear of long head of biceps tendon; Frozen shoulder; Diabetes mellitus.(5) Interventions:Ten five-minute secessions of ultrasound in ultrasound group, ultra sound group treatment plus low level laser therapy in every session in LASER+ultrasound group, Injection of 1ml of methylprednisolon acetate 40 mg/ml under ultrasound guide inside and outside of the tendon sheath in other two groups. (6) Main outcome measures: Primary outcome is VAS score of pain which will be assessed pre-treatment, 1 week, 1 month, 3 months and one year after intervention. Secondary outcome is Constant-Morley score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502257274N11
Registration date:2015-03-09, 1393/12/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-09, 1393/12/18
Registrant information
Name
Mohsen Mardani Kivi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 1470
Email address
mardani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between therapeutic responses to ultrasound, low level LASER+ultrasound, sonographically guided extra and intra tendon's sheath corticosteroid injection in the treatment of long head of biceps tendinitis
Public title
Comparison between four therapeutic methods in the treatment of long head of biceps tendinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of pain in shoulder or upper extremity for more than 3 months; Point tenderness in bicipital groove; At least one positive biceps tendon test (active compression test, Yergoson test, speed test or biceps instability); No evidence of partial or complete rotator cuff tear.
Exclusion criteria: History of shoulder surgery or injection; Any calcification (or calcareous deposit) in rotator cuff; Any sign of dislocation, subluxation, partial or complete tear of long head of biceps tendon; Frozen shoulder; Diabetes mellitus.
Age
From 14 years old to 139 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Guilan University of Medical Sciences
Street address
Research vice-chancellor of Guilan university of medical sciences building, Shahid Beheshti blv.
City
Rasht
Postal code
Approval date
2014-10-27, 1393/08/05
Ethics committee reference number
1930349903
Health conditions studied
1
Description of health condition studied
Long head of biceps tendinitis
ICD-10 code
M75.2
ICD-10 code description
Bicipital tendinitis
Primary outcomes
1
Description
Pain intensity
Timepoint
VAS score of pain which will be assessed pre-treatment, 1 week, 1 month, 3 months and one year after intervention
Method of measurement
Visual Analogue Scale score (VAS)
Secondary outcomes
1
Description
Functional status of shoulder
Timepoint
pre-treatment, 1 week, 1 month, 3 months and one year after intervention
Method of measurement
Constant-Morley score
Intervention groups
1
Description
First group-control (Ultrasound): 10 session (3 session a week) of ultrasound (frequency:1MHz, intensity:1W/cm2, Cycle: 2:8, Transducer section area: 5 cm2) for 5 minutes will administer in this group
Category
Rehabilitation
2
Description
Second group-intervention (Ultrasound+Low level LASER): In addition to ultrasound like the first group, the Ga-As-Al LASER (Wave Lenght:830 nm, Power:30mW, Intensity:1 J/cm2, Beam diameter:4mm, Angle:2.5 degree) with a pencil probe will be execute.
Category
Rehabilitation
3
Description
Third group-intervention (Intra tendon sheath injection): 1 ml of Methylprednisolon acetate (40 mg/ml) with 1ml of Lidocaine 2% will be injected into the long head of biceps tendon sheath using a 1.5 inches 25 gauge needle under the guide of ultrasound. From the day after injection ultrasound will be administered same as the control group.
Category
Treatment - Drugs
4
Description
Fourth group-intervention (Extra tendon sheath injection): All devices and methods are similar to the third group but the injection will be executed outside the tendon sheath.