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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Electroacupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of either sex with primary osteoarthritis of one or both knees fulfilling diagnostic criteria for osteoarthritis knee laid down by American College of Rheumatology. Patients also had to have a Kellgren-Lawrence (radiologic criterion) score of at least 2 and chronic pain in the knee joint for more than 3 months. Exclusion Criteria: The patients with secondary osteoarthritis of knees Associated systemic arthropathies, e.g. rheumatoid arthritis and gout Patients on steroids Disease modifying drugs, e.g. methotrexate and azathioprine Patients with recent trauma in the area of acupuncture History of intra articular injection of steroid within last two months Patients missing two or more sessions of electro-acupuncture consecutively were excluded from the study

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: placebo/sham acupuncture<br>There are different types of controls used in acupuncture trials. We used the control described as sham and by some as minimal acupuncture. This group had the same schedule as the electro-acupuncture group. Sham acupuncture was administered, with the same duration and frequency and by the same specialist who performed the non-sham acupuncture. Retractable needles were placed into small adhesive cylinders, so that the needles were supported but did not perforate the skin. The acupuncturist placed the needles at the same points as the non-sham group and used the same pairs of electrodes to simulate the electrical connection. | Device: Electroacupuncture<br>* 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.<br>|
| Active Comparator: Electroacupuncture<br>The electro-acupuncture device was a biphasic pulse generator. It was used with maximum tolerable intensity of current and a frequency of 3 Hz. The points were selected according to the Traditional Chinese Medicine meridian theory to treat knee pain. The points selected were local points St 34, St 35, St 36,Liv 8, Sp 10. One distal point St 44.A total of six needles were inserted into each leg by the acupuncturist (the out come measures were not specifically targeted to whether the patient had one or both knees involved). All patients belonging to this group experienced a De Qi sensation, which is a tingling and numbness sensation upon needling of specific points. | Device: Electroacupuncture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | baseline and the completion of treatment at 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey | patient-perceived quality of life | at 1 month | 
| Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey | patient-perceived quality of life | at 3 months | 
| Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey | patient-perceived quality of life | at 6 months | 
| Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey | patient-perceived quality of life | up to 1 year | 
| Change from baseline in plasma cortisol and beta-endorphins levels | analysis of blood samples | at 1 month | 
| Change from baseline in plasma cortisol and beta-endorphins levels | analysis of blood samples | at 3 months | 
| Change from baseline in plasma cortisol and beta-endorphins levels | analysis of blood samples | at 6 months | 
| Change from baseline in plasma cortisol and beta-endorphins levels | analysis of blood samples | 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 | 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 | 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 | 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 | 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. | 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. | 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. | up to 1 year | 
| Changes in baseline use of medication | EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire | at 1 month | 
| Changes in baseline use of medication | EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire | at 3 months | 
| Changes in baseline use of medication | EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire | at 6 months | 
| Changes in baseline use of medication | EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire | 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) | 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) | 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) | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, knee pain