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Comparative results of the use of corticoid and hyaluronic acid in the treatment of shoulder arthrosis.

Hilano G-F 20 versus triamcinolone in the treatment of primary shoulder osteoarthrosis. Randomized controlled clinical trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-66tppc
Enrollment
Unknown
Registered
2019-02-28
Start date
2018-07-02
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erosive (osteo)arthrosis

Interventions

We will evaluate 30 patients with primary glenohumeral osteoarthrosis who did not present satisfactory results after conservative treatment for at least 6 months. Two groups: 1) Hyaluronic Acid Group:
2) Triamcinolone group: Patients will receive an intra-articular injection with triamcinolone, associated with standard treatment.
Drug
Procedure/surgery

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Adult patients without distinction of age or gender; Present diagnosis of primary shoulder osteoarthrosis with radiological confirmation, Segment availability during the study period; Have had previous conservative treatment without improvement of symptoms for a minimum period of 6 months; EVA of pain> or equal to 4; Have signed an informed consent form to participate in the study.

Exclusion criteria

Exclusion criteria: Shoulder previous surgery, Shoulder viscosupplementation, Rotator cuff arthropathy, Adhesive capsulitis, Shoulder osteoarthrosis secondary to fracture, infection, osteonecrosis, rheumatologic disease, Continuous use of corticoid, Chronic treatment with immunosuppressive or anticoagulant drugs

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of intra-articular injection of hylan G-F 20 in primary shoulder osteoarthrosis compared to intra-articular injection of triancinolone through the numerical visual pain scale and scores of Constant, UCLA modified and Shoulder Pain and Disability Index (SPADI). To measure pain in the patient's shoulder, we used the numerical visual scale (NVA) of the pain. The patient scored on the scale of 0 to 10 the intensity of his pain. Being 0 when there was no pain, 1 to 2 for mild pain, 3 to 7 for moderate pain, 8 to 9 for severe pain and 10 for the worst possible pain. The Constant Score is a scoring system that combines physical examination tests with subjective assessments by patients. The subjective evaluation consists of 35 points and the remaining 65 points are assigned to the evaluation of the physical examination. The subjective assessment includes a single item for pain (15 points) and 4 items for activities of daily living (work 4, sport 4, sleep 2 and positioning of the hand in space (10 points). 10 points, 10 points, 10 points, internal rotation, 10 points, external rotation, 10 points) and power (score based on the number of pounds of traction that the patient can withstand in abduction for a maximum of 25 points, measured with the aid of a dynamometer.) The UCLA modified score is composed of the following domains: pain (10 points), function (10 points), amplitude of active anterior flexion (5 points), manual force test for anterior flexion (5 points) and patient satisfaction (5 points), totaling 35 points. life daily) and patient satisfaction are evaluated through questioning and the items amplitude of the previous active flexion and manual force test for anterior flexion, through routine physical examination. The score is classified as follows: 34-35 points correspond to excellent results, 28-33 good results, 21-27 reasonable and 0-20 bad. The questionnaire Shoulder Pain and Disability Index (SPADI) is a self-administered index that has

Secondary

MeasureTime frame
Evaluate if results are maintained for up to 24 weeks through the numerical visual pain scale and scores of Constant, UCLA modified and Shoulder Pain and Disability Index (SPADI). To measure pain in the patient's shoulder, we used the numerical visual scale (NVA) of the pain. The patient scored on the scale of 0 to 10 the intensity of his pain. Being 0 when there was no pain, 1 to 2 for mild pain, 3 to 7 for moderate pain, 8 to 9 for severe pain and 10 for the worst possible pain. The Constant Score is a scoring system that combines physical examination tests with subjective assessments by patients. The subjective evaluation consists of 35 points and the remaining 65 points are assigned to the evaluation of the physical examination. The subjective assessment includes a single item for pain (15 points) and 4 items for activities of daily living (work 4, sport 4, sleep 2 and positioning of the hand in space (10 points). 10 points, 10 points, 10 points, internal rotation, 10 points, external rotation, 10 points) and power (score based on the number of pounds of traction that the patient can withstand in abduction for a maximum of 25 points, measured with the aid of a dynamometer.) The UCLA modified score is composed of the following domains: pain (10 points), function (10 points), amplitude of active anterior flexion (5 points), manual force test for anterior flexion (5 points) and patient satisfaction (5 points), totaling 35 points. life daily) and patient satisfaction are evaluated through questioning and the items amplitude of the previous active flexion and manual force test for anterior flexion, through routine physical examination. The score is classified as follows: 34-35 points correspond to excellent results, 28-33 good results, 21-27 reasonable and 0-20 bad. The questionnaire Shoulder Pain and Disability Index (SPADI) is a self-administered index that has 13 items divided into 2 subscales: pain (5 items) and disability (8 items). Scores for individual items

Countries

Brazil

Contacts

Public ContactSimone Tortato

Universidade Federal de São Paulo

cete@uol.com.br551155764848

Outcome results

None listed

Source: REBEC (via WHO ICTRP)