Introduction: Knee osteoarthritis is a long-term rheumatic disease with a significant impact on the patient's quality of life and the socio-economic development of societies. The usual treatment consists of non-steroidal anti-inflammatory drugs as a palliative measure. The decrease in the beneficial effect and the appearance of serious long-term adverse effects make it necessary to look for other therapeutic procedures. Acupuncture is a non-pharmacological treatment that could reduce pain and improve functionality in this condition, however current scientific evidence is limited. A previous study has observed a clinical improvement in the combination of sensitized local and peripheral points in the treatment of knee osteoarthritis but studies with a larger sample are needed to confirm these results. Objective: Assess the effectiveness of acupuncture using a combination of local and peripheral sensitized points in the treatment of active knee osteoarthritis. Methods: A randomized clinical trial will be performed in a hospital centre with 2 groups. The control group will standard treatment plus transcutaneous electrical nerve stimulation, while the intervention group will receive acupuncture in addition to standard care. Study outcomes will be pain, quality of life, function, exercise adherence, drug intake, adverse effects, and body mass index. There will be a 12-month post-intervention follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
56
Acupuncture is a non-pharmacological technique that consists in the stimulation of specific points located in the skin surface. Points are stimulated by piercing the skin with fine needles.
TENS is a therapy that uses low voltage electrical current to provide pain relief. A TENS unit consists of a battery-powered device that delivers electrical impulses through electrodes placed on the surface of your skin. The electrodes are placed at or near nerves where the pain is located or at trigger points.
Change from Baseline Pain at post intervention
Pain will be assessed using the visual analogue scale (VAS)
Time frame: At the end of the intervention, at the 4th week of the study
Change from Baseline Knee function at postintervention
Knee function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: At the end of the intervention, at the 4th week of the study
Change from Baseline Quality of life at postintervention
Quality of life will be assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Time frame: At the end of the intervention, at the 4th week of the study
Change from Baseline Pain at 4 months
Pain will be assessed using the visual analogue scale (VAS)
Time frame: 16 weeks afther the end of the intervention, at the 20th week of the study
Change from Baseline Knee function at 4 months
Knee function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 16 weeks afther the end of the intervention, at the 20th week of the study
Change from Baseline Quality of life at 4 months
Quality of life will be assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Time frame: 16 weeks afther the end of the intervention, at the 20th week of the study
Drug intake postintervention
Rescue drug intake will be collected in the data collection notebooks
Time frame: through study completion, an average of 1 year
Adverse events postintervention
Any adverse event related with the treatments will be will be noted in a collection sheet.
Time frame: through study completion, an average of 1 year
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