Evaluation of the efficacy of three different methods in the treatment of rotator cuff tendinopathy of shoulder; Dextrose-prolotherapy, Corticosteroid injections and Physical therapy.
Comparative study of the effectiveness of 3 methods of corticosteroid injections, prolotherapy with dextrose and physical exercise in treatment of partial tearing of rotator cuff tendons in the shoulder
Design
In this study, asa phase 3 clinical trial, 114 patients aged 65-18 years old with shoulder pain were enrolled in the study according to the inclusion criteria. All patients are trained in the Numerical Rating Scale and SPADI shoulder disability criteria. Each patient will be randomly distributed in one of three groups: Proloterapy, Corticosteroid and Physical exercises.
Settings and conduct
Patients with shoulder pain referring to the pain clinic of Imam Hossein and Akhtar hospitals will participate in this study.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 65 years with shoulder pain (for at least 6 weeks) who inflammation and relative damage to rotator cuff tendons are approved by physical examination and imaging techniques, are included in the study.
Patients with a history of shoulder surgery, diabetes, malignancy, and various types of immune system disorders will not be included in the study.
Intervention groups
Group P (Prolotherapy):
8 cc of dextrose solution of 12.5% contains 40 mg lidocaine in the 3-5 points around the shoulder joint.
Group C (corticosteroid ):
8 cc of 0.1% lidocaine solution containing 80 mg of triamcinolone will be injected in the area surrounding the supraspinatus and sub-scapular tendons and around the suprascapular nerve.
Group E (physical exercises):
8 cc of lidocaine solution 1% in the area around the supraspinatus and sub-scapular tendons and around the suprascapular nerve. Then, after 1 week, 10 sessions of physical therapy will be started with Tense, Ultrasound, Hot Package modalities.
Anesthesiology ward of Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 8072
Email address
asadisa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of three different methods in the treatment of rotator cuff tendinopathy of shoulder; Dextrose-prolotherapy, Corticosteroid injections and Physical therapy.
Public title
Comparison of therapeutic effect of prolotherapy by glucose, corticosteroid and physical therapy in shoulder teddinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Shoulder pain for at least 6 weeks
Rotator cuff tendinopathy has been confirmed by physical examination and imaging methods
Patient between 18-65 years old
Exclusion criteria:
Past history of shoulder surgery
Diabete mellitus
Malignancy
Immune insufficiency disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the arrival of patients in each of the three study groups, a restriced randomization method using the random allocation rule will be done.This randomization method is used to balance the number of people assigned to each of the groups at the end of the sample collection. In this study, taking into account 38 patients for each group, a total of 120 patients will be considered for entry and randomization. In this method, 120 small balls of the same size are considered in three different colors; 30 yellow balls representing prolethropopy, 30 blue balls representing corticosteroids and 30 green balls representing physical therapy. All small balls are placed in a bag and for each patient, a ball is pulled out of the bag.
Blinding (investigator's opinion)
Double blinded
Blinding description
At the begining of the study, all patients in the three groups will be injected in the same place. Post-injection care is the same in all three groups. The only difference is in patients with the "physical therapy" group, which physical therapies will start 1 week after the injection. It is worth noting that patients in any of the three groups are not aware of the content of the injections.
The collecting person as well as the person analyzing the data are not aware of the patient's treatment method.
Placebo
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 Sciences
Injury or partial tearing of rotator cuff tendons of the shoulder
ICD-10 code
M67.9
ICD-10 code description
Unspecified disorder of synovium and tendon
Primary outcomes
1
Description
Pain scale and disability in patients with injury or partial tearing of rotator cuff tendons of the shoulder
Timepoint
Measure the pain and disability of the shoulder joint at the beginning of the study (before the intervention) and one week, one month and three months after the end of the treatment interventions
Method of measurement
"Numerical Rating Scale" and "Shoulder Pain And Disability Index"
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Prolotherapy by dextrose. In this group, after placing the patient in the sitting position, 8 cc of dextrose solution 12.5% containing 40 mg lidocaine will be injected in the 3 to 5 points around the shoulder joint (adjacent to the supraspinatus and subscapularis tendons, and other points with tenderness Around the joint) with a 25 gauge, 3.5 cm needle.
Category
Treatment - Other
2
Description
Intervention group 2: Corticosteroid injection. In this group, after placement of the patient in the sitting position and under ultrasound guide, 8 cc of 0.1% lidocaine solution containing 80 mg of triamcinolone will be injected in the area adjacent to the supraspinatus and subscapularis tendons (Needle gauge 25, cm5) and around the suprascapular nerve (Needle, 9 cm , 23 gauge).
Category
Treatment - Other
3
Description
Intervention group 3: Physical therapy. In this group, after placement of the patient in the sitting position and under ultrasound guide, 8 cc of lidocaine solution 1% will be injected in the area adjacent to the supraspinatus and subscapularis tendons (Needle 25 gauge, 5 cm) and around the suprascapular nerve (spinal needle 23 gauge, 9 cm), and after 1 week, the patient will undergo 10 sessions of physical therapy [every other day] with Tense, Ultrasound and Hot Pack modalities.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Saman Asadi
Street address
Shahid Madani Ave., Imam Ali Blvd.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
info@ehmc.ir
2
Recruitment center
Name of recruitment center
Akhtar hospital
Full name of responsible person
Saman Asadi
Street address
Sharifi manesh Ave., Elahyeh
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
akhtarhospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sayed Ali Ziaee
Street address
Yaman Ave., Shahid Chamran Blvd
City
Tehran
Province
Tehran
Postal code
1134845763
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?