Clinical trial NCT05955430: Percutaneous Electrical Stimulation, Education and Exercise Program in Patients With Knee Osteoarthritis
Official title: Efficacy of Percutaneous Electrical Stimulation Compared to Transcutaneous Electrical Stimulation in Combination With an Education and Exercise Program in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Physiotherapy
Physical Therapy
Conditioned Pain Modulation
Temporal Summation of pain
Knee pain
PENS
Percutaneous electrical stimulation
Pain education
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline to one month in WOMAC
timeFrame: At baseline and at one month
measure: Change from baseline to three months in WOMAC
timeFrame: At baseline and at three months
measure: Change from baseline to six months in WOMAC
timeFrame: At baseline and at six months
measure: Change from baseline to immediately after the first session in VAS
timeFrame: At baseline and immediately after the first session
measure: Change from baseline to one month in VAS
timeFrame: At baseline and at one month
measure: Change from baseline to three months in VAS
timeFrame: At baseline and at three months
measure: Change from baseline to six months in VAS
timeFrame: At baseline and at six months
Secondary outcomes:
measure: Change from baseline to immediately after the first session in PPT
timeFrame: At baseline and immediately after the first session
measure: Change from baseline to one month in PPT
timeFrame: At baseline and at one month
measure: Change from baseline to three months in PPT
timeFrame: At baseline and at three months
measure: Change from baseline to six months in PPT
timeFrame: At baseline and at six months
measure: Change from baseline to immediately after the first session in CPM
timeFrame: At baseline and immediately after the first session
measure: Change from baseline to one month in CPM
timeFrame: At baseline and at one month
measure: Change from baseline to three months in CPM
timeFrame: At baseline and at three months
measure: Change from baseline to six months in CPM
timeFrame: At baseline and at six months
measure: Change from baseline to immediately after the first session in TSP
timeFrame: At baseline and immediately after the first session
measure: Change from baseline to one month in TSP
timeFrame: At baseline and at one month
measure: Change from baseline to three months in TSP
timeFrame: At baseline and at three months
measure: Change from baseline to six months in TSP
timeFrame: At baseline and at six months
measure: Change from baseline to one month in TUG
timeFrame: At baseline and at one month
measure: Change from baseline to three months in TUG
timeFrame: At baseline and at three months
measure: Change from baseline to six months in TUG
timeFrame: At baseline and at six months
measure: Change from baseline to one month in GCPS
timeFrame: At baseline and at one month
measure: Change from baseline to three months in GCPS
timeFrame: At baseline and at three months
measure: Change from baseline to six months in GCPS
timeFrame: At baseline and at six months
measure: Baseline Mini-Mental Status
timeFrame: At baseline
measure: Change from baseline to one month in STAI
timeFrame: At baseline and at one month
measure: Change from baseline to three months in STAI
timeFrame: At baseline and at three months
measure: Change from baseline to six months in STAI
timeFrame: At baseline and at six months
measure: Change from baseline to one month in BDI-II
timeFrame: At baseline and at one month
measure: Change from baseline to three months in BDI-II
timeFrame: At baseline and at three months
measure: Change from baseline to six months in BDI-II
timeFrame: At baseline and at six months
measure: Change from baseline to one month in PCS
timeFrame: At baseline and at one month
measure: Change from baseline to three months in PCS
timeFrame: At baseline and at three months
measure: Change from baseline to six months in PCS
timeFrame: At baseline and at six months
measure: Change from baseline to one month in TSK-11
timeFrame: At baseline and at one month
measure: Change from baseline to three months in TSK-11
timeFrame: At baseline and at three months
measure: Change from baseline to six months in TSK-11
timeFrame: At baseline and at six months
measure: Change from baseline to immediately after the first intervention in catastrophism in vivo
timeFrame: At baseline and immediately after the first intervention
measure: Change from baseline to one month in CRES-4
timeFrame: At baseline and at one month
measure: Change from baseline to three months in CRES-4
timeFrame: At baseline and at three months
measure: Change from baseline to six months in CRES-4
timeFrame: At baseline and at six months
measure: Change from baseline to one month in GROC
timeFrame: At baseline and at one month
measure: Change from baseline to three months in GROC
timeFrame: At baseline and at three months
measure: Change from baseline to six months in GROC
timeFrame: At baseline and at six months
measure: Baseline Demographic and Clinical Characteristics
timeFrame: At baseline
measure: Change from baseline to one month in SPPB
timeFrame: At baseline and at one month
measure: Change from baseline to three months in SPPB
timeFrame: At baseline and at three months
measure: Change from baseline to six months in SPPB
timeFrame: At baseline and at six months
measure: Change from baseline to one month in SF-12
timeFrame: At baseline and at one month
measure: Change from baseline to three months in SF-12
timeFrame: At baseline and at three months
measure: Change from baseline to six months in SF-12
timeFrame: At baseline and at six months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Rey Juan Carlos
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Josué Fernández Carnero, PhD
role: PRINCIPAL_INVESTIGATOR
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