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

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee

• Registration Number: NCT02299713
• Lead Sponsor: Hospital Son Llatzer

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.

Study Timeline

• Study First Submitted: 2014-11-11
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Study Start: 2015-01
• Primary Completion: 2017-02
• Status Verified: 2017-11
• Study Completion: 2017-11
• Last Update Submitted: 2020-04-05
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes from baseline in visual analogue scale (VAS) and the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index pain subscale	baseline and the completion of treatment at 12 weeks.	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)

Secondary Outcome Measures

Name	Time	Method
Change from baseline in WOMAC index	up to 1 year	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.
Change from Baseline in Goldberg Depression and Anxiety scales	up to 1 year	measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al. will be used
Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey	up to 1 year	patient-perceived quality of life
Change from baseline in plasma cortisol and beta-endorphins levels	up to 1 year	analysis of blood samples
Changes in baseline use of medication	up to 1 year	EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire
Change from baseline in a visual analogue scale (VAS)	up to 1 year	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)

Trial Locations

Locations (2)

Son Llatzer University Hospital; 🇪🇸 Palma, Balear Islands, Spain

Son LLàtzer Hospital; 🇪🇸 Palma, Balearic Islands, Spain