Percutaneous Electrical Stimulation, Education and Exercise Program in Patients With Knee Osteoarthritis

Josue Fernandez Carnero

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Other: Transcutaneous electrical stimulation; Other: Pain education; Other: Placebo stimulation; Other: Therapeutic exercise; Other: Percutaneous electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05955430

KOA1

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness of percutaneous electrotherapy treatment with transcutaneous and placebo.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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)
• Unable to commit to study requirements (unable to attend study appointments or complete study outcomes)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

30 participants in 3 patient groups, including a placebo group

Exercise, education and PENS

Experimental group

Description:

Patients will receive eight face-to-face sessions of therapeutic exercise, four sessions of pain education and eight sessions of percutaneous electrical stimulation (PENS).

Treatment:

Other: Therapeutic exercise

Other: Percutaneous electrical stimulation

Other: Pain education

Exercise, education and TENS

Active Comparator group

Description:

Patients will receive eight face-to-face sessions of therapeutic exercise, four sessions of pain education and eight sessions of transcutaneous electrical stimulation (TENS).

Treatment:

Other: Transcutaneous electrical stimulation

Other: Therapeutic exercise

Other: Pain education

Exercise, education and placebo stimulation

Placebo Comparator group

Description:

Patients will receive eight face-to-face sessions of therapeutic exercise, four sessions of pain education and eight sessions of placebo stimulation.

Treatment:

Other: Placebo stimulation

Other: Therapeutic exercise

Other: Pain education