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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02299713
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Javier Mata, Hospital Son Llatzer

Tracking Information
First Submitted Date  ICMJE November 11, 2014
First Posted Date  ICMJE November 24, 2014
Last Update Posted Date November 21, 2017
Study Start Date  ICMJE January 2015
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2017)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
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. ]
Change History Complete list of historical versions of study NCT02299713 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2017)
  • Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey [ Time Frame: at 1 month ]
    patient-perceived quality of life
  • Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey [ Time Frame: at 3 months ]
    patient-perceived quality of life
  • Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey [ Time Frame: at 6 months ]
    patient-perceived quality of life
  • 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
  • Change from baseline in plasma cortisol and beta-endorphins levels [ Time Frame: at 1 month ]
    analysis of blood samples
  • Change from baseline in plasma cortisol and beta-endorphins levels [ Time Frame: at 3 months ]
    analysis of blood samples
  • Change from baseline in plasma cortisol and beta-endorphins levels [ Time Frame: at 6 months ]
    analysis of blood samples
  • Change from baseline in plasma cortisol and beta-endorphins levels [ Time Frame: up to 1 year ]
    analysis of blood samples
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • Changes in baseline use of medication [ Time Frame: at 1 month ]
    EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire
  • Changes in baseline use of medication [ Time Frame: at 3 months ]
    EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire
  • Changes in baseline use of medication [ Time Frame: at 6 months ]
    EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire
  • Changes in baseline use of medication [ Time Frame: 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) [ 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
  • Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey [ Time Frame: at 1 month ]
    patient-perceived quality of life
  • Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey [ Time Frame: at 3 months ]
    patient-perceived quality of life
  • Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey [ Time Frame: at 6 months ]
    patient-perceived quality of life
  • 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
  • Change from baseline in plasma cortisol and beta-endorphins levels [ Time Frame: at 1 month ]
    analysis of blood samples
  • Change from baseline in plasma cortisol and beta-endorphins levels [ Time Frame: at 3 months ]
    analysis of blood samples
  • Change from baseline in plasma cortisol and beta-endorphins levels [ Time Frame: at 6 months ]
    analysis of blood samples
  • Change from baseline in plasma cortisol and beta-endorphins levels [ Time Frame: up to 1 year ]
    analysis of blood samples
  • Change from Baseline in Goldberg Depression and Anxiety scales [ Time Frame: at 1 month ]
  • Change from Baseline in Goldberg Depression and Anxiety scales [ Time Frame: at 3 months ]
  • Change from Baseline in Goldberg Depression and Anxiety scales [ Time Frame: at 6 months ]
  • Change from Baseline in Goldberg Depression and Anxiety scales [ Time Frame: up to 1 year ]
  • Change from baseline in WOMAC index [ Time Frame: at 1 month ]
  • Change from baseline in WOMAC index [ Time Frame: at 6 months ]
  • Change from baseline in WOMAC index [ Time Frame: up to 1 year ]
  • Changes in baseline use of medication [ Time Frame: at 1 month ]
    EUROHIS theoretical recommendations and design of a questionnaire
  • Changes in baseline use of medication [ Time Frame: at 3 months ]
    EUROHIS theoretical recommendations and design of a questionnaire
  • Changes in baseline use of medication [ Time Frame: at 6 months ]
    EUROHIS theoretical recommendations and design of a questionnaire
  • Changes in baseline use of medication [ Time Frame: up to 1 year ]
    EUROHIS theoretical recommendations and design of a questionnaire
  • Change from baseline in a visual analogue scale (VAS) [ Time Frame: at 1 month ]
  • Change from baseline in a visual analogue scale (VAS) [ Time Frame: at 6 months ]
  • Change from baseline in a visual analogue scale (VAS) [ Time Frame: up to 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electro-Acupuncture Treatment in Patients With Osteoarthritis Of The Knee (EATOAK)
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE Device: Electroacupuncture
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.
Study Arms  ICMJE
  • Sham Comparator: placebo/sham acupuncture
    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.
    Intervention: Device: Electroacupuncture
  • Active Comparator: Electroacupuncture
    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.
    Intervention: Device: Electroacupuncture
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2017)
160
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2014)
128
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02299713
Other Study ID Numbers  ICMJE ACU-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Javier Mata, Hospital Son Llatzer
Study Sponsor  ICMJE Hospital Son Llatzer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Javier Mata, M.D. Anaesthesia Department, Son Llàtzer Hospital. Ctra. de Manacor kilómetro 4. 07198. Palma de Mallorca. Spain
PRS Account Hospital Son Llatzer
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP