Osteoarthritis, Knee
Conditions
Keywords
Acupuncture, Osteoarthritis, Knee
Brief summary
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.
Interventions
OTHERAcupuncture
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.
DEVICETENS
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.
Sponsors
Universitat de Girona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Pain at post intervention | At the end of the intervention, at the 4th week of the study | Pain will be assessed using the visual analogue scale (VAS) |
| Change from Baseline Knee function at postintervention | At the end of the intervention, at the 4th week of the study | Knee function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
| Change from Baseline Quality of life at postintervention | At the end of the intervention, at the 4th week of the study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug intake postintervention | through study completion, an average of 1 year | Rescue drug intake will be collected in the data collection notebooks |
| Change from Baseline Pain at 4 months | 16 weeks afther the end of the intervention, at the 20th week of the study | Pain will be assessed using the visual analogue scale (VAS) |
| Adverse events postintervention | through study completion, an average of 1 year | Any adverse event related with the treatments will be will be noted in a collection sheet. |
| Change from Baseline Knee function at 4 months | 16 weeks afther the end of the intervention, at the 20th week of the study | Knee function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
| Change from Baseline Quality of life at 4 months | 16 weeks afther the end of the intervention, at the 20th week of the study | 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. |
Contacts
Primary ContactTomás Tegiacchi
Backup ContactCarles Fernández
Outcome results
None listed