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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
160
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.
Son Llatzer University Hospital
Palma, Balear Islands, Spain
Son LLàtzer Hospital
Palma, Balearic Islands, Spain
Changes from baseline in visual analogue scale (VAS) and the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index pain subscale
a continuous scale comprised of a horizontal line, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 100 \[100-mm scale\]). (VAS pain intensity score)
Time frame: baseline and the completion of treatment at 12 weeks.
Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey
patient-perceived quality of life
Time frame: at 1 month
Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey
patient-perceived quality of life
Time frame: at 3 months
Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey
patient-perceived quality of life
Time frame: at 6 months
Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey
patient-perceived quality of life
Time frame: up to 1 year
Change from baseline in plasma cortisol and beta-endorphins levels
analysis of blood samples
Time frame: at 1 month
Change from baseline in plasma cortisol and beta-endorphins levels
analysis of blood samples
Time frame: at 3 months
Change from baseline in plasma cortisol and beta-endorphins levels
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analysis of blood samples
Time frame: at 6 months
Change from baseline in plasma cortisol and beta-endorphins levels
analysis of blood samples
Time frame: up to 1 year
Change from Baseline in Goldberg Depression and Anxiety scales
measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al. will be used
Time frame: at 1 month
Change from Baseline in Goldberg Depression and Anxiety scales
measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al. will be used
Time frame: at 3 months
Change from Baseline in Goldberg Depression and Anxiety scales
measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al. will be used
Time frame: at 6 months
Change from Baseline in Goldberg Depression and Anxiety scales
measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al. will be used
Time frame: up to 1 year
Change from baseline in WOMAC index
WOMAC scale. There are two questions for stiffness (scale of 0-8) and 17 questions for functional limitation (score range of 0-68). Each question will be answered orally with the following criteria: "none" = 0, "a bit" = 1, "quite a bit" = 2, "a lot" = 3, and "very much" = 4. If two or more questions are unanswered, the scale scores will be declared invalid and not counted.
Time frame: at 1 month
Change from baseline in WOMAC index
WOMAC scale. There are two questions for stiffness (scale of 0-8) and 17 questions for functional limitation (score range of 0-68). Each question will be answered orally with the following criteria: "none" = 0, "a bit" = 1, "quite a bit" = 2, "a lot" = 3, and "very much" = 4. If two or more questions are unanswered, the scale scores will be declared invalid and not counted.
Time frame: at 6 months
Change from baseline in WOMAC index
WOMAC scale. There are two questions for stiffness (scale of 0-8) and 17 questions for functional limitation (score range of 0-68). Each question will be answered orally with the following criteria: "none" = 0, "a bit" = 1, "quite a bit" = 2, "a lot" = 3, and "very much" = 4. If two or more questions are unanswered, the scale scores will be declared invalid and not counted.
Time frame: up to 1 year
Changes in baseline use of medication
EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire
Time frame: at 1 month
Changes in baseline use of medication
EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire
Time frame: at 3 months
Changes in baseline use of medication
EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire
Time frame: at 6 months
Changes in baseline use of medication
EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire
Time frame: up to 1 year
Change from baseline in a visual analogue scale (VAS)
a continuous scale comprised of a horizontal line, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 100 \[100-mm scale\]). (VAS pain intensity score)
Time frame: at 1 month
Change from baseline in a visual analogue scale (VAS)
a continuous scale comprised of a horizontal line, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 100 \[100-mm scale\]). (VAS pain intensity score)
Time frame: at 6 months
Change from baseline in a visual analogue scale (VAS)
a continuous scale comprised of a horizontal line, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 100 \[100-mm scale\]). (VAS pain intensity score)
Time frame: up to 1 year