N-Acetyl Cysteine ??Injection in knee and hip for Arthrosis treatment

N-Acetyl Cysteine Joint Infiltration ??in the treatment of hip and knee Osteoarthritis - NAC N-acetyl cysteine

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-4nvxt7x

Enrollment

Unknown

Registered

2023-06-23

Start date

2023-06-05

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

Knee Osteoarthritis

Interventions

This is a double-blind controlled clinical study of medical staff and patients

both the researches who will evaluate the outcomes and the participants will not know which group each participant belongs to. Patients will be randomly distributed between two groups of 35 individual

E02.319.267.530.380

Eligibility

Inclusion criteria

Inclusion criteria: Patients of both sexes; no age limits; symptomatic knee osteoarthritis for more than 6 months and with access to physical therapy

Exclusion criteria

Exclusion criteria: Patients with a history of joint surgeries; use of dual antidepressants up to 60 days before the initial assessment; regular use of therapeutic or prophylactic anticoagulants; use of gabapentinoids up to 60 days before the initial evaluation; use of oral or intramuscular corticosteroid therapy up to 60 days before the assessment; previous joint infiltration up to 12 months before the initial evaluation; neurological deficits; disabling systemic disease; chemical immunosuppression or secondary to microbiological agents; use of antirheumatic agents; active infectious conditions; past history of joint infection; diabetes mellitus and glycated hemoglobin greater than 7.0% in the last 6 months

Design outcomes

Primary

Measure	Time frame
An improvement in the limitation of patients with osteoarthritis of the knee and hip is expected with the infiltration of N-acetyl cysteine; evaluated through the application of the Western Ontario McMAster Unversities Arthritis Index (WOMAC), Haris Hip Score (HHS), visual analogue scale (VAS), the World Health Organization questionnaire for quality of life (WHO_QOL), to be applied on the day infiltration, 15 days and 6 months after the procedure ;An improvement in the pain of patients with osteoarthritis of the knee and hip is expected with the infiltration of N-acetyl cysteine; evaluated through the application of the Western Ontario McMAster Unversities Arthritis Index (WOMAC), Haris Hip Score (HHS), visual analogue scale (VAS), the World Health Organization questionnaire for quality of life (WHO_QOL), to be applied on the day infiltration, 15 days and 6 months after the procedure;An improvement in the quality of life of patients with knee and hip osteoarthritis is expected with N-acetyl cysteine ??infiltration; evaluated through the application of the Western Ontario McMAster Unversities Arthritis Index (WOMAC), Haris Hip Score (HHS), visual analogue scale (VAS), the World Health Organization questionnaire for quality of life (WHO_QOL), to be applied on the day infiltration, 15 days and 6 months after the procedure	—

Measure

Time frame

An improvement in the limitation of patients with osteoarthritis of the knee and hip is expected with the infiltration of N-acetyl cysteine; evaluated through the application of the Western Ontario McMAster Unversities Arthritis Index (WOMAC), Haris Hip Score (HHS), visual analogue scale (VAS), the World Health Organization questionnaire for quality of life (WHO_QOL), to be applied on the day infiltration, 15 days and 6 months after the procedure ;An improvement in the pain of patients with osteoarthritis of the knee and hip is expected with the infiltration of N-acetyl cysteine; evaluated through the application of the Western Ontario McMAster Unversities Arthritis Index (WOMAC), Haris Hip Score (HHS), visual analogue scale (VAS), the World Health Organization questionnaire for quality of life (WHO_QOL), to be applied on the day infiltration, 15 days and 6 months after the procedure;An improvement in the quality of life of patients with knee and hip osteoarthritis is expected with N-acetyl cysteine ??infiltration; evaluated through the application of the Western Ontario McMAster Unversities Arthritis Index (WOMAC), Haris Hip Score (HHS), visual analogue scale (VAS), the World Health Organization questionnaire for quality of life (WHO_QOL), to be applied on the day infiltration, 15 days and 6 months after the procedure

—

Secondary

Measure	Time frame
An improvement is expected in the biochemical markers of oxidative stress measured in the synovial fluid of patients treated with N-acetyl cysteine, collected immediately before the infiltration and 6 months after. Concentrations of chondroitin-6 sulfate, matrix metalloproteinase-3, type 2 collagen cross-chain c-terminal telopeptide, total antioxidant status and total concentration of antioxidants will be evaluated	—

Measure

Time frame

An improvement is expected in the biochemical markers of oxidative stress measured in the synovial fluid of patients treated with N-acetyl cysteine, collected immediately before the infiltration and 6 months after. Concentrations of chondroitin-6 sulfate, matrix metalloproteinase-3, type 2 collagen cross-chain c-terminal telopeptide, total antioxidant status and total concentration of antioxidants will be evaluated

—

Countries

Brazil

Contacts

Public ContactEliseu Barros

Santa Casa de Belo Horizonte - Ensino e Pesquisa

eliseubarros@gmail.com+55-31-987111353

Outcome results

None listed

Source: REBEC (via WHO ICTRP)