Clinical trial NCT06744036: Effects of Including Interferential Current in a Therapeutic Exercise Program in Individuals With Knee Osteoarthritis
Official title: Effects of Including Interferential Current in a Therapeutic Exercise Program in Individuals With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 126
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The first-line treatment for knee osteoarthritis (KOA) in terms of pain and functionality is physical exercise. The use of interferential current (IC) associated with other resources may be beneficial in reducing pain intensity and improving functionality. However, the effects of its simultaneous use with therapeutic exercise have not yet been fully established. The aim of this project will be to evaluate the effects of including IC in a therapeutic exercise program in relation to pain intensity, functionality, self-efficacy, maximum voluntary contraction and overall perceived effect in individuals with KOA. Therefore, research participants of both sexes, between 40 and 75 years old, with a clinical diagnosis of unilateral KOA, who have knee pain for more than 3 months, with a minimum score of 3 points on the numerical pain scale, morning stiffness for less than 30 minutes, crepitation, bone sensitivity and absence of palpable heat will be recruited. The research participants will be randomized into three groups: therapeutic exercises (n=42) and therapeutic exercises + IC (n=42) and therapeutic exercises + IC placebo. Eight consecutive weeks of treatment will be carried out. The research participants will be evaluated before the intervention, after the end of the intervention of eight consecutive weeks of intervention and after four weeks at the end of the last week of intervention, through the instruments: numeric pain scale (NPS), Knee Injury and Osteoarthritis Outcome Score (KOOS), patient-specific functional scale (EFEP), Pain self-efficacy questionnaire (PSEQ), maximum voluntary isometric contraction (MVIC), 30-second sit-to-stand test (TSL30s), global perception scale (EPG). For data analysis, a normality test will be used to verify the distribution of the data and a statistical test appropriate for the appropriate intra and inter-group comparisons, thus considering two factors in the comparisons, time and group. A significance level of 5% will be adopted.


Eligibility criteria: Inclusion Criteria:

* both sexes
* between 40 years old and 75 years old
* with a clinical diagnosis of unilateral KOA
* Who has had knee pain for more than 3 months
* With a minimum score of 3 points on the numerical pain scale
* Morning stiffness for less than 30 minutes
* Crepitus
* Bone tenderness and absence of palpable heat

Exclusion Criteria:

* Hip OA
* Severe osteoporosis
* Fibromyalgia
* Clinical history of tumors or cancer
* Active inflammatory joint diseases (rheumatoid arthritis, gout)
* Undergoing any joint replacement in the lower extremity
* Neurological diseases (Parkinson's disease, stroke
* Multiple sclerosis
* muscular dystrophies
* Diseases involving motor neurons
* Alzheimer's disease
* Infected wounds or osteomyelitis in the knee region
* Deep vein thrombosis or thrombophlebitis
* Sensory alteration in the lower limbs
* Cognitive and cardiopulmonary impairment that may prevent or limit the execution of exercises
* Use of a walking assistance device
* History of recent knee trauma
* Having undergone any form of treatment involving physical therapy
* intra-articular corticosteroids
* anti-inflammatory drugs
* opioid medication or chondroprotective in the six months before the start of the interventions

Primary outcomes:
measure: Numerical Pain Scale
timeFrame: before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session
Secondary outcomes:
measure: Functional disability
timeFrame: before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session
measure: Functional self-perception
timeFrame: before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session
measure: Functional capacity
timeFrame: before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session
measure: Inability
timeFrame: before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session
measure: Maximum voluntary isometric contraction
timeFrame: before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session
measure: Global Perception of Change scale
timeFrame: before the first treatment session, after 8 weeks of treatment and 4 weeks after the end of the last session
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Nove de Julho
Study officials:
References: