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Completed

NCT Number: NCT02299713

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Son Llatzer University Hospital, Palma, Balear Islands, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electroacupuncture

Device

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.

Primary outcomes

  1. Changes from baseline in visual analogue scale (VAS) and the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index pain subscale

    Time frame: 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 outcomes

  1. Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey

    Time frame: at 1 month

    patient-perceived quality of life

  2. Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey

    Time frame: at 3 months

    patient-perceived quality of life

  3. Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey

    Time frame: at 6 months

    patient-perceived quality of life

  4. Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey

    Time frame: up to 1 year

    patient-perceived quality of life

  5. Change from baseline in plasma cortisol and beta-endorphins levels

    Time frame: at 1 month

    analysis of blood samples

  6. Change from baseline in plasma cortisol and beta-endorphins levels

    Time frame: at 3 months

    analysis of blood samples

  7. Change from baseline in plasma cortisol and beta-endorphins levels

    Time frame: at 6 months

    analysis of blood samples

  8. Change from baseline in plasma cortisol and beta-endorphins levels

    Time frame: up to 1 year

    analysis of blood samples

  9. Change from Baseline in Goldberg Depression and Anxiety scales

    Time frame: at 1 month

    measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al. will be used

  10. Change from Baseline in Goldberg Depression and Anxiety scales

    Time frame: at 3 months

    measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al. will be used

  11. Change from Baseline in Goldberg Depression and Anxiety scales

    Time frame: at 6 months

    measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al. will be used

  12. Change from Baseline in Goldberg Depression and Anxiety scales

    Time frame: up to 1 year

    measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al. will be used

  13. Change from baseline in WOMAC index

    Time frame: at 1 month

    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.

  14. Change from baseline in WOMAC index

    Time frame: at 6 months

    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.

  15. Change from baseline in WOMAC index

    Time frame: 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.

  16. Changes in baseline use of medication

    Time frame: at 1 month

    EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire

  17. Changes in baseline use of medication

    Time frame: at 3 months

    EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire

  18. Changes in baseline use of medication

    Time frame: at 6 months

    EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire

  19. Changes in baseline use of medication

    Time frame: up to 1 year

    EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire

  20. Change from baseline in a visual analogue scale (VAS)

    Time frame: at 1 month

    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)

  21. Change from baseline in a visual analogue scale (VAS)

    Time frame: at 6 months

    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)

  22. Change from baseline in a visual analogue scale (VAS)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hospital Son Llatzer

Other

Registry information

Official study 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

Acronym: EATOAK

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 24, 2014
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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