Efficacy of Percutaneous Electrical Stimulation Compared to Transcutaneous Electrical Stimulation in Combination With an Education and Exercise Program in Patients With Knee Osteoarthritis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- Josue Fernandez Carnero
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change from baseline to immediately after the first session in VAS
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to compare the effectiveness of percutaneous electrotherapy treatment with transcutaneous and placebo.
Detailed Description
There is evidence of the benefit of therapeutic exercise on pain intensity and functionality in patients with osteoarthritis of the knee. However, there is a lack of evidence of its effectiveness when applied in combination with new treatment strategies such as percutaneous electrostimulation and therapeutic pain education.
Investigators
Josue Fernandez Carnero
Professor
Universidad Rey Juan Carlos
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 45 years
- •Have activity related joint pain
- •Have morning stiffness ≤30 min
- •Knee pain of at least 6 months duration
- •OA diagnosis by physician
- •Current levels of moderate/vigorous physical activity (MVPA) below physical activity guideline recommendations (\< 150 min/week of MVPA; assessed using the Active Australia Physical Activity Questionnaire)
Exclusion Criteria
- •Health conditions that prevent safe participation in physical activity interventions as listed in the American College of Sports Medicine Guidelines (e.g., cardiac or lung disease).
- •Pain in other body areas that currently limits walking ability (e.g., back pain, foot pain, hip pain)
- •Neurological disorders affecting lower limb movement (e.g., multiple sclerosis or stroke).
- •Inflammatory arthritis (including rheumatoid arthritis)
- •Fibromyalgia
- •Previously operated knee is the most painful knee
- •Any condition impacting decision-making/memory (e.g., Alzheimer's, dementia)
- •Severe depression
- •Current moderate/vigorous physical activity levels above guideline recommendations (≥150 min/week; assessed using the Active Australia Physical Activity Questionnaire)
- •Currently undergoing regular, active intervention for the knee (e.g., seeing a physiotherapist)
Outcomes
Primary Outcomes
Change from baseline to immediately after the first session in VAS
Time Frame: At baseline and immediately after the first session
The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
Change from baseline to one month in WOMAC
Time Frame: At baseline and at one month
The Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index is a specific questionnaire for knee and hip osteoarthritis that assesses pain, stiffness and functional capacity, currently recommended by several international organizations for the evaluation of this disease.
Change from baseline to three months in WOMAC
Time Frame: At baseline and at three months
The Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index is a specific questionnaire for knee and hip osteoarthritis that assesses pain, stiffness and functional capacity, currently recommended by several international organizations for the evaluation of this disease.
Change from baseline to three months in VAS
Time Frame: At baseline and at three months
The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
Change from baseline to six months in WOMAC
Time Frame: At baseline and at six months
The Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index is a specific questionnaire for knee and hip osteoarthritis that assesses pain, stiffness and functional capacity, currently recommended by several international organizations for the evaluation of this disease.
Change from baseline to one month in VAS
Time Frame: At baseline and at one month
The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
Change from baseline to six months in VAS
Time Frame: At baseline and at six months
The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
Secondary Outcomes
- Change from baseline to three months in PPT(At baseline and at three months)
- Change from baseline to immediately after the first session in CPM(At baseline and immediately after the first session)
- Change from baseline to one month in PPT(At baseline and at one month)
- Change from baseline to six months in PPT(At baseline and at six months)
- Change from baseline to three months in CPM(At baseline and at three months)
- Change from baseline to immediately after the first session in TSP(At baseline and immediately after the first session)
- Change from baseline to three months in GCPS(At baseline and at three months)
- Change from baseline to immediately after the first session in PPT(At baseline and immediately after the first session)
- Change from baseline to six months in CPM(At baseline and at six months)
- Change from baseline to three months in TSP(At baseline and at three months)
- Change from baseline to six months in TUG(At baseline and at six months)
- Baseline Mini-Mental Status(At baseline)
- Change from baseline to six months in STAI(At baseline and at six months)
- Change from baseline to three months in PCS(At baseline and at three months)
- Change from baseline to one month in TSP(At baseline and at one month)
- Change from baseline to six months in GCPS(At baseline and at six months)
- Change from baseline to one month in CPM(At baseline and at one month)
- Change from baseline to one month in TUG(At baseline and at one month)
- Change from baseline to three months in TUG(At baseline and at three months)
- Change from baseline to one month in BDI-II(At baseline and at one month)
- Change from baseline to immediately after the first intervention in catastrophism in vivo(At baseline and immediately after the first intervention)
- Change from baseline to one month in GROC(At baseline and at one month)
- Change from baseline to three months in GROC(At baseline and at three months)
- Change from baseline to six months in SPPB(At baseline and at six months)
- Change from baseline to six months in TSP(At baseline and at six months)
- Change from baseline to one month in GCPS(At baseline and at one month)
- Change from baseline to three months in STAI(At baseline and at three months)
- Change from baseline to six months in PCS(At baseline and at six months)
- Change from baseline to six months in CRES-4(At baseline and at six months)
- Change from baseline to six months in GROC(At baseline and at six months)
- Change from baseline to one month in STAI(At baseline and at one month)
- Change from baseline to six months in BDI-II(At baseline and at six months)
- Change from baseline to one month in PCS(At baseline and at one month)
- Change from baseline to three months in TSK-11(At baseline and at three months)
- Change from baseline to one month in CRES-4(At baseline and at one month)
- Change from baseline to three months in CRES-4(At baseline and at three months)
- Change from baseline to one month in SF-12(At baseline and at one month)
- Change from baseline to three months in BDI-II(At baseline and at three months)
- Change from baseline to one month in TSK-11(At baseline and at one month)
- Change from baseline to six months in TSK-11(At baseline and at six months)
- Baseline Demographic and Clinical Characteristics(At baseline)
- Change from baseline to one month in SPPB(At baseline and at one month)
- Change from baseline to three months in SPPB(At baseline and at three months)
- Change from baseline to six months in SF-12(At baseline and at six months)
- Change from baseline to three months in SF-12(At baseline and at three months)