Protocol summary
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Study aim
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The effect of Sono-guided Oxygen-ozone/ corticosteroid and prolotherapy local injection in the treatment of Shoulder tendonitis
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Design
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Phase 3, multi-center, double blind randomized controlled clinical trial, with parallel group design. The study will be done on 45 patients (15 in each group), and follow-up will be done two week , two months and six months after the injection
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Settings and conduct
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Department of Physical Medicine and Rehabilitation of Firoozgar Hospital and Physiotherapy and Rehabilitation Physics Department of Rasoul Akram Medical Center affiliated to Iran University of Medical Sciences
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Tendinopathy in patients with positive one of the shoulder tests including Neer test or Hawkins test, VAS greater than 4, Patient's desire to attend the research project. Exclusion criteria: rotator cuff tear, diabetes, coagulation disorders, fracture, rheumatologic diseases, tumors and infection,history of Injection in the shoulder joint in the last 3 months, Frozen Shoulder, Presence of c6-c5 Concomitant radiculopathy.
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Intervention groups
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Topical ozone injection group: 5cc ozone 20μg/L Corticosteroid injection group: 1cc triamcinolone 40mg + 1cc lidocaine and prolotherapy group: 5cc dextrose 20%
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Main outcome variables
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Visual Analogue Scale (VAS); shoulder pain and disability index (SPADI)
General information
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Reason for update
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Modifications are needed in the execution method, date and place.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151017024572N17
Registration date:
2018-07-12, 1397/04/21
Registration timing:
prospective
Last update:
2025-05-13, 1404/02/23
Update count:
2
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Registration date
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2018-07-12, 1397/04/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-05-10, 1398/02/20
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Expected recruitment end date
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2024-06-22, 1403/04/02
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Actual recruitment start date
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2019-05-10, 1398/02/20
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Actual recruitment end date
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2024-06-22, 1403/04/02
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Trial completion date
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2024-12-22, 1403/10/02
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Scientific title
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Comparing ultrasound guided injection of oxygen-ozone vs. corticosteroid vs. prolotherapy in the treatment of shoulder tendinopathy : a randomized, prospective, multicenter randomized clinical trial
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Public title
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Comparing local injection of ozone, corticosteroid and prolotherapy under ultrasound guidance in the treatment of inflammation of shoulder tendons
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
The presence of tandinopathy in patients as a positive one in a special shoulder test, including: Neer test, Hawkins test
Visual Analog Scale (VAS) above 4
Patient's desire to attend research project
Exclusion criteria:
Existence of a history and examination of rotator cuff tears, diabetes, coagulation disorders, fractures, rheumatologic diseases, tumors and infection
Receiving injection in the shoulder joint in the last 3 months
Frozen Shoulder
Presence of c6-c5 synchronous radiculopathy
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Age
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From 20 years old to 80 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
45
Actual sample size reached:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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A simple random method for randomization will be used and individuals (patients) will form random units. A random sequence will be generated using RAS software. A central randomization method will be used to conceal random allocation. The random sequence will be created by the statistician and will be available to her. The doctor will be connected to the statistician by telephone or text message and will ask him or her about the random allocation of the participant to the specific group.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In order to blind the patient, the doctor will prepare the injection material in the syringe, and will cover the syringes with an aluminum sheet to avoid being aware of the type of injection. It should be noted that dilution of corticosteroid and normal salin will be done to equalize the volume of all three injectable solutions.
Patients in each group will be evaluated by a physical medicine and rehabilitation specialist, who is not aware of the type of injection, before the injection, two week , two months and six months after the injection.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-07-08, 1396/04/17
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Ethics committee reference number
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IR.IUMS.REC 1396.30322
Health conditions studied
1
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Description of health condition studied
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Inflammation of the shoulder tendons
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ICD-10 code
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G59
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ICD-10 code description
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Mononeuropathy in diseases classified elsewhere
Primary outcomes
1
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Description
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Pain score based on Visual Analogue Scale
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Timepoint
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Before injection, two weeks , two months and six months after the injection
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Method of measurement
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Visual Analog Scale (VAS)
2
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Description
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Shoulder pain and disability
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Timepoint
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Before injection, two weeks , two months and six months after the injection
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Method of measurement
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Shoulder pain and disability index (SPADI)
Secondary outcomes
1
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Description
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Clinical Global Impression
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Timepoint
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Before injection, two weeks , two months and six months after the injection
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Method of measurement
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Clinical Global Impression Questionnaire
2
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Description
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Patient Global Impression of Improvement
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Timepoint
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Before injection, two weeks , two months and six months after the injection
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Method of measurement
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Patient Global Impression of Improvement Questionnaire
3
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Description
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shoulder rang of motiom
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Timepoint
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Before injection, two weeks , two months and six months after the injection
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Method of measurement
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goniometer
4
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Description
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Subacromial bursaThickness
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Timepoint
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Before injection, two weeks , two months and six months after the injection
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Method of measurement
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sonography
5
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Description
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Constant Score
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Timepoint
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Before injection, two weeks , two months and six months after the injection
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Method of measurement
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Constant Score Questionnaire
Intervention groups
1
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Description
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Intervention group (ozone therapy): 5cc ozone 20μg / L, in subacromial space with lateral aperture under ultrasound guidance.
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Category
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Treatment - Drugs
2
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Description
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Intervention group (porlotherapy): 5cc dextrose 20%, in subacromial space with lateral aperture under ultrasound guidance.
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Category
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Treatment - Drugs
3
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Description
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Control group (corticosteroid therapy ): 1cc triamcinolone 40mg + 1cc lidocaine , in subacromial space with lateral aperture under ultrasound guidance.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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70
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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30
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available