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Effects of Semi-standarized Acupuncture in Chronical Symptomatic Osteoarthritis of the Knee Through: A Randomized Controlled Trial

Primary Purpose

Osteoarthritis, Knee

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
TENS
Sponsored by
Universitat de Girona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Acupuncture, Osteoarthritis, Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Usual painful episode of 3 months or more
  • Morning stiffness of 15 minutes or more
  • Pain equal to or greater than 5 on the VAS
  • Grade 2 or greater on the Kellgren-Lawrence scale

Exclusion Criteria:

  • Corticosteroid infiltration in the 3 months prior to recruitment
  • Rehabilitation treatment one month prior to recruitment
  • With a knee prosthesis
  • Needle phobia
  • Pregnancy
  • With pacemakers
  • Cardiac arrhythmias

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Usual care plus TENS

    Usual care plus Acupuncture

    Arm Description

    Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) and usual care. TENS treatment will perform in the region of the knee and the extensor muscles for 20 minutes, 2 times a week. 4 electrodes will be placed, 2 on the proximal region of the internal and external vastus, and the other 2 on the distal region of the motor plate. Usual care will consist in home exercises with toning exercises of the extensor apparatus, pelvic region and musculoskeletal stretching exercises of 2 weekly sessions, the recommendation of daily activity of walking for 1 hour daily as an active lifestyle and the recommendation of the reduction of body weight in the case of being above normal weight. There will be a total of 6 face-to-face sessions at the rate of 2 weekly sessions

    Participants in this group will receive acupuncture treatment and usual care. Acupuncture treatment will consist in 20-minute semi-standardized acupuncture sessions, 2 times a week. The intervention will consist of the insertion of 8 needles: 4 in points located in the knee (points St34, St35, XiYan and Sp10) and 4 more sensitive to palpation points located between the knee and the ankle. Stimulation will be performed to obtain local spasm response, the needles will be left for 20 minutes and then removed. The needles will be sterile disposable silicone needles of 0.20x20mm and 0.20x40mm. Usual care will be the same described in the Usual care plus TENS group

    Outcomes

    Primary Outcome Measures

    Change from Baseline Pain at post intervention
    Pain will be assessed using the visual analogue scale (VAS)
    Change from Baseline Knee function at postintervention
    Knee function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
    Change from Baseline Quality of life at postintervention
    Quality of life will be assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

    Secondary Outcome Measures

    Change from Baseline Pain at 4 months
    Pain will be assessed using the visual analogue scale (VAS)
    Change from Baseline Knee function at 4 months
    Knee function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
    Change from Baseline Quality of life at 4 months
    Quality of life will be assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
    Drug intake postintervention
    Rescue drug intake will be collected in the data collection notebooks
    Adverse events postintervention
    Any adverse event related with the treatments will be will be noted in a collection sheet.

    Full Information

    First Posted
    September 29, 2021
    Last Updated
    October 14, 2021
    Sponsor
    Universitat de Girona
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05096806
    Brief Title
    Effects of Semi-standarized Acupuncture in Chronical Symptomatic Osteoarthritis of the Knee Through: A Randomized Controlled Trial
    Official Title
    Effects of Semi-standarized Acupuncture in Chronical Symptomatic Osteoarthritis of the Knee Through: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2022 (Anticipated)
    Primary Completion Date
    November 1, 2023 (Anticipated)
    Study Completion Date
    November 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitat de Girona

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Introduction: Knee osteoarthritis is a long-term rheumatic disease with a significant impact on the patient's quality of life and the socio-economic development of societies. The usual treatment consists of non-steroidal anti-inflammatory drugs as a palliative measure. The decrease in the beneficial effect and the appearance of serious long-term adverse effects make it necessary to look for other therapeutic procedures. Acupuncture is a non-pharmacological treatment that could reduce pain and improve functionality in this condition, however current scientific evidence is limited. A previous study has observed a clinical improvement in the combination of sensitized local and peripheral points in the treatment of knee osteoarthritis but studies with a larger sample are needed to confirm these results. Objective: Assess the effectiveness of acupuncture using a combination of local and peripheral sensitized points in the treatment of active knee osteoarthritis. Methods: A randomized clinical trial will be performed in a hospital centre with 2 groups. The control group will standard treatment plus transcutaneous electrical nerve stimulation, while the intervention group will receive acupuncture in addition to standard care. Study outcomes will be pain, quality of life, function, exercise adherence, drug intake, adverse effects, and body mass index. There will be a 12-month post-intervention follow-up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee
    Keywords
    Acupuncture, Osteoarthritis, Knee

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual care plus TENS
    Arm Type
    Active Comparator
    Arm Description
    Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) and usual care. TENS treatment will perform in the region of the knee and the extensor muscles for 20 minutes, 2 times a week. 4 electrodes will be placed, 2 on the proximal region of the internal and external vastus, and the other 2 on the distal region of the motor plate. Usual care will consist in home exercises with toning exercises of the extensor apparatus, pelvic region and musculoskeletal stretching exercises of 2 weekly sessions, the recommendation of daily activity of walking for 1 hour daily as an active lifestyle and the recommendation of the reduction of body weight in the case of being above normal weight. There will be a total of 6 face-to-face sessions at the rate of 2 weekly sessions
    Arm Title
    Usual care plus Acupuncture
    Arm Type
    Experimental
    Arm Description
    Participants in this group will receive acupuncture treatment and usual care. Acupuncture treatment will consist in 20-minute semi-standardized acupuncture sessions, 2 times a week. The intervention will consist of the insertion of 8 needles: 4 in points located in the knee (points St34, St35, XiYan and Sp10) and 4 more sensitive to palpation points located between the knee and the ankle. Stimulation will be performed to obtain local spasm response, the needles will be left for 20 minutes and then removed. The needles will be sterile disposable silicone needles of 0.20x20mm and 0.20x40mm. Usual care will be the same described in the Usual care plus TENS group
    Intervention Type
    Other
    Intervention Name(s)
    Acupuncture
    Intervention Description
    Acupuncture is a non-pharmacological technique that consists in the stimulation of specific points located in the skin surface. Points are stimulated by piercing the skin with fine needles.
    Intervention Type
    Device
    Intervention Name(s)
    TENS
    Other Intervention Name(s)
    Transcutaneous electrical nerve stimulation
    Intervention Description
    TENS is a therapy that uses low voltage electrical current to provide pain relief. A TENS unit consists of a battery-powered device that delivers electrical impulses through electrodes placed on the surface of your skin. The electrodes are placed at or near nerves where the pain is located or at trigger points.
    Primary Outcome Measure Information:
    Title
    Change from Baseline Pain at post intervention
    Description
    Pain will be assessed using the visual analogue scale (VAS)
    Time Frame
    At the end of the intervention, at the 4th week of the study
    Title
    Change from Baseline Knee function at postintervention
    Description
    Knee function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
    Time Frame
    At the end of the intervention, at the 4th week of the study
    Title
    Change from Baseline Quality of life at postintervention
    Description
    Quality of life will be assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
    Time Frame
    At the end of the intervention, at the 4th week of the study
    Secondary Outcome Measure Information:
    Title
    Change from Baseline Pain at 4 months
    Description
    Pain will be assessed using the visual analogue scale (VAS)
    Time Frame
    16 weeks afther the end of the intervention, at the 20th week of the study
    Title
    Change from Baseline Knee function at 4 months
    Description
    Knee function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
    Time Frame
    16 weeks afther the end of the intervention, at the 20th week of the study
    Title
    Change from Baseline Quality of life at 4 months
    Description
    Quality of life will be assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
    Time Frame
    16 weeks afther the end of the intervention, at the 20th week of the study
    Title
    Drug intake postintervention
    Description
    Rescue drug intake will be collected in the data collection notebooks
    Time Frame
    through study completion, an average of 1 year
    Title
    Adverse events postintervention
    Description
    Any adverse event related with the treatments will be will be noted in a collection sheet.
    Time Frame
    through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Usual painful episode of 3 months or more Morning stiffness of 15 minutes or more Pain equal to or greater than 5 on the VAS Grade 2 or greater on the Kellgren-Lawrence scale Exclusion Criteria: Corticosteroid infiltration in the 3 months prior to recruitment Rehabilitation treatment one month prior to recruitment With a knee prosthesis Needle phobia Pregnancy With pacemakers Cardiac arrhythmias
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tomás Tegiacchi
    Phone
    0034676364399
    Email
    tomasjtg@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carles Fernández
    Phone
    0034651503494
    Email
    carlesfj@blanquerna.url.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    26439406
    Citation
    Roos EM, Arden NK. Strategies for the prevention of knee osteoarthritis. Nat Rev Rheumatol. 2016 Feb;12(2):92-101. doi: 10.1038/nrrheum.2015.135. Epub 2015 Oct 6.
    Results Reference
    background
    PubMed Identifier
    29198932
    Citation
    Vickers AJ, Vertosick EA, Lewith G, MacPherson H, Foster NE, Sherman KJ, Irnich D, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. J Pain. 2018 May;19(5):455-474. doi: 10.1016/j.jpain.2017.11.005. Epub 2017 Dec 2.
    Results Reference
    background
    PubMed Identifier
    28267751
    Citation
    Woods B, Manca A, Weatherly H, Saramago P, Sideris E, Giannopoulou C, Rice S, Corbett M, Vickers A, Bowes M, MacPherson H, Sculpher M. Cost-effectiveness of adjunct non-pharmacological interventions for osteoarthritis of the knee. PLoS One. 2017 Mar 7;12(3):e0172749. doi: 10.1371/journal.pone.0172749. eCollection 2017.
    Results Reference
    background
    PubMed Identifier
    24761164
    Citation
    Cao H, Bourchier S, Liu J. Does Syndrome Differentiation Matter? A Meta-Analysis of Randomized Controlled Trials in Cochrane Reviews of Acupuncture. Med Acupunct. 2012 Jun;24(2):68-76. doi: 10.1089/acu.2011.0846.
    Results Reference
    background
    PubMed Identifier
    31305415
    Citation
    Li J, Li YX, Luo LJ, Ye J, Zhong DL, Xiao QW, Zheng H, Geng CM, Jin RJ, Liang FR. The effectiveness and safety of acupuncture for knee osteoarthritis: An overview of systematic reviews. Medicine (Baltimore). 2019 Jul;98(28):e16301. doi: 10.1097/MD.0000000000016301.
    Results Reference
    background

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    Effects of Semi-standarized Acupuncture in Chronical Symptomatic Osteoarthritis of the Knee Through: A Randomized Controlled Trial

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