NCT02299713

Electro-Acupuncture Treatment in Patients With Osteoarthritis Of The Knee (EATOAK)

Randomized, Double-Blind, Placebo-Controlled Trial, Parallel Design Used To Evaluate Pain, Endocrinologic Variations, Life Quality And Medication Use, After Electro-Acupuncture Treatment In Patients With Osteoarthritis Of The Knee

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Hospital Son Llatzer · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the efficacy of electroacupuncture (EA) on pain control, perception of pain, plasma cortisol and beta-endorphins levels, patient-perceived quality of life and use of pain medications, in people with chronic knee pain.

Detailed description

Previous randomised trials and meta-analyses have shown certain efficacy of acupuncture in some chronic painful conditions, in spite of methodological weaknesses. The hypothalamic-pituitary-adrenal (HPA) axis and the endogenous opioid (EO) system are the mechanisms appear to explain how acupuncture works in part. These systems have been shown to be important mediators of stress, pain and other stimuli. The Osteoarthritis Research International suggest that osteoarthritis (OA) treatment should be multidisciplinary and recommended acupuncture as one of 12 possible non-pharmacological modalities for treating OA. This study is a randomized, double-blind, placebo-controlled trial, parallel design. 128 out-patients over 50 years with OA of the knee will be recruited from Mallorca, Spain. Participants will be randomly allocated into two groups: placebo/sham acupuncture, non insertion technique, and EA. Acupuncture treatments will be used the Traditional Chinese Medicine (TCM) style. The patients will be evaluated after a period of one month (2 sessions weekly), three months (1session monthly), six months (1 session every 45 days) and again one year later (1 session every 2 months), at the end of the study.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	Electroacupuncture	Electro acupuncture is a relatively new method of treatment in Chinese Medicine. Just as in a regular acupuncture treatment, needles are inserted into acupuncture points but small crocodile clips are then attached to the ends of needles to connect them to an electro-acupuncture device. In traditional acupuncture the inserted needles are manually vibrated to induce a response whilst in electro-acupuncture the bi-phasic current results in a constant (controlled) vibration of the needles and a direct electrical stimulation. The device allows the practitioner to adjust the frequency and intensity of the electric stimulation in a consistent manner which is not operator dependant.

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-02-01
• Completion: 2017-11-01
• First posted: 2014-11-24
• Last updated: 2020-04-07

Locations

2 sites across 1 country: Spain