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Hyaluronic Acid Injection for the management of shoulder Impact Syndrome

Hyaluronic Acid Injection for the management of shoulder Impact Syndrome. Triple blind randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6t2b47y
Enrollment
Unknown
Registered
2023-04-25
Start date
2023-06-01
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

Shoulder Impingement Syndrome

Interventions

This is a randomized clinical trial developed in a single center with three randomized parallel groups. 66 patients will be included in the study. Once included in the study, each patient will be allo
Corticosteroid (CT)
Placebo (SF), in the proportion of 1:1:1, with randomization performed through software (http://www.randomizer.org). and the allocation of patients will be carried out through sealed and opaque envelo

Sponsors

Fundação Faculdade de Medicina de São José do Rio Preto
Lead Sponsor
Fundação Faculdade de Medicina de São José do Rio Preto
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Volunteer of both genders; presenting shoulder impingement syndrome with at least three months of symptoms without improvement with conservative treatment; older than 18 years; who have not had previous infiltrations in the evaluated shoulder; no medical contraindications to local anesthesia

Exclusion criteria

Exclusion criteria: Individuals with complete rotator cuff injuries or injuries greater than 50% of the tendon thickness or with traumatic cuff injuries; those submitted to previous infiltrations in the shoulder; who have a previous disease that may interfere with the result of the outcome assessment; with medical contraindication to anesthesia or any of the proposed treatments; with inability to maintain outpatient clinical follow-up

Design outcomes

Primary

MeasureTime frame
Pain will be assessed using the Visual Analog Pain Scale (VAS). It is expected to find a decrease of at least 30% in pain on the VAS between the initial pre-infiltration evaluation and the post-infiltration evaluations at 2, 4, 12 and 24 weeks.

Secondary

MeasureTime frame
The UCLA-modified score (Modified University of California at Los Angeles) will be used to assess function. An improvement in the score is expected, with an increase in the score between the initial and final evaluations.;Function evaluation will also be performed using the Constant score adapted for Portuguese. An improvement in the score is expected, with an increase in the score between the initial and final evaluations.

Countries

Brazil

Contacts

Public ContactOreste Carrazzone

Fundação Faculdade de Medicina de São José do Rio Preto

dr.oreste@hotmail.com+55(17)32015000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)