Effects of Semi-standarized Acupuncture in Chronical Symptomatic Osteoarthritis of the Knee Through: A Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Semi-standarized Acupuncture in Chronical Symptomatic Osteoarthritis of the Knee Through: A Randomized Controlled Trial

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Other: Acupuncture
* Device: TENS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Usual painful episode of 3 months or more Morning stiffness of 15 minutes or more Pain equal to or greater than 5 on the VAS Grade 2 or greater on the Kellgren-Lawrence scale Exclusion Criteria: Corticosteroid infiltration in the 3 months prior to recruitment Rehabilitation treatment one month prior to recruitment With a knee prosthesis Needle phobia Pregnancy With pacemakers Cardiac arrhythmias

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care plus TENS<br>Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) and usual care. TENS treatment will perform in the region of the knee and the extensor muscles for 20 minutes, 2 times a week. 4 electrodes will be placed, 2 on the proximal region of the internal and external vastus, and the other 2 on the distal region of the motor plate. Usual care will consist in home exercises with toning exercises of the extensor apparatus, pelvic region and musculoskeletal stretching exercises of 2 weekly sessions, the recommendation of daily activity of walking for 1 hour daily as an active lifestyle and the recommendation of the reduction of body weight in the case of being above normal weight. There will be a total of 6 face-to-face sessions at the rate of 2 weekly sessions | Device: TENS<br>* 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.<br>* Other names: Transcutaneous electrical nerve stimulation;|
| Experimental: Usual care plus Acupuncture<br>Participants in this group will receive acupuncture treatment and usual care. Acupuncture treatment will consist in 20-minute semi-standardized acupuncture sessions, 2 times a week. The intervention will consist of the insertion of 8 needles: 4 in points located in the knee (points St34, St35, XiYan and Sp10) and 4 more sensitive to palpation points located between the knee and the ankle. Stimulation will be performed to obtain local spasm response, the needles will be left for 20 minutes and then removed. The needles will be sterile disposable silicone needles of 0.20x20mm and 0.20x40mm. Usual care will be the same described in the Usual care plus TENS group | Other: Acupuncture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Pain at post intervention | Pain will be assessed using the visual analogue scale (VAS) | 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) | 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. | At the end of the intervention, at the 4th week of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Pain at 4 months | Pain will be assessed using the visual analogue scale (VAS) | 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) | 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. | 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 | 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. | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Osteoarthritis, Knee