Clinical trial NCT02299713: Electro-Acupuncture Treatment in Patients With Osteoarthritis Of The Knee (EATOAK)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: acupuncture
knee pain
Lead sponsor: Hospital Son Llatzer
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline in visual analogue scale (VAS) and the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index pain subscale
timeFrame: baseline and the completion of treatment at 12 weeks.
Secondary outcomes:
measure: Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey
timeFrame: at 1 month
measure: Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey
timeFrame: at 3 months
measure: Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey
timeFrame: at 6 months
measure: Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey
timeFrame: up to 1 year
measure: Change from baseline in plasma cortisol and beta-endorphins levels
timeFrame: at 1 month
measure: Change from baseline in plasma cortisol and beta-endorphins levels
timeFrame: at 3 months
measure: Change from baseline in plasma cortisol and beta-endorphins levels
timeFrame: at 6 months
measure: Change from baseline in plasma cortisol and beta-endorphins levels
timeFrame: up to 1 year
measure: Change from Baseline in Goldberg Depression and Anxiety scales
timeFrame: at 1 month
measure: Change from Baseline in Goldberg Depression and Anxiety scales
timeFrame: at 3 months
measure: Change from Baseline in Goldberg Depression and Anxiety scales
timeFrame: at 6 months
measure: Change from Baseline in Goldberg Depression and Anxiety scales
timeFrame: up to 1 year
measure: Change from baseline in WOMAC index
timeFrame: at 1 month
measure: Change from baseline in WOMAC index
timeFrame: at 6 months
measure: Change from baseline in WOMAC index
timeFrame: up to 1 year
measure: Changes in baseline use of medication
timeFrame: at 1 month
measure: Changes in baseline use of medication
timeFrame: at 3 months
measure: Changes in baseline use of medication
timeFrame: at 6 months
measure: Changes in baseline use of medication
timeFrame: up to 1 year
measure: Change from baseline in a visual analogue scale (VAS)
timeFrame: at 1 month
measure: Change from baseline in a visual analogue scale (VAS)
timeFrame: at 6 months
measure: Change from baseline in a visual analogue scale (VAS)
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Palma
country: Spain
facility: Son Llatzer University Hospital
state: Balear Islands
city: Palma
country: Spain
facility: Son LLàtzer Hospital
state: Balearic Islands
Study officials:
affiliation: Anaesthesia Department, Son Llàtzer University Hospital. Palma de Mallorca. Spain
name: Javier Mata, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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