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Osteoarthritis, KneeNCT05096806

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

A study testing Acupuncture and TENS in people with Osteoarthritis, Knee, run by Universitat de Girona.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Acupuncture and TENS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
No sites listed yet
Study dates
1 Jan 2022to 1 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Tomás Tegiacchi contact

0034676364399

tomasjtg@gmail.com

Carles Fernández contact

0034651503494

carlesfj@blanquerna.url.edu

About this study

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.

Read more

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.

Being tested
Acupuncture, TENS
Keywords
Acupuncture, Osteoarthritis, Knee
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupunctureOther

    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.

  • TENSDevice

    Also called Transcutaneous electrical nerve stimulation

    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.

Study groups in NCT05096806
Study groupRoleWhat they receive
Usual care plus TENSActive comparatorParticipants 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
Receives: Device: TENS
Usual care plus AcupunctureExperimentalParticipants 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
Receives: Other: Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Pain at post intervention

    Pain will be assessed using the visual analogue scale (VAS)

    Measured: At the end of the intervention, at the 4th week of the study

  2. Change from Baseline Knee function at postintervention

    Knee function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Measured: At the end of the intervention, at the 4th week of the study

  3. 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.

    Measured: At the end of the intervention, at the 4th week of the study

Secondary outcomes (5)

  1. Change from Baseline Pain at 4 months

    Pain will be assessed using the visual analogue scale (VAS)

    Measured: 16 weeks afther the end of the intervention, at the 20th week of the study

  2. Change from Baseline Knee function at 4 months

    Knee function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Measured: 16 weeks afther the end of the intervention, at the 20th week of the study

  3. 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.

    Measured: 16 weeks afther the end of the intervention, at the 20th week of the study

  4. Drug intake postintervention

    Rescue drug intake will be collected in the data collection notebooks

    Measured: through study completion, an average of 1 year

  5. Adverse events postintervention

    Any adverse event related with the treatments will be will be noted in a collection sheet.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2021
  2. Study start1 Jan 2022 (estimated)
  3. Primary completion1 Nov 2023 (estimated)
  4. Study completion1 Nov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05096806
Sponsor's protocol ID
CEBRU0021-21
Status last verified
Oct 2021
First submitted
29 Sep 2021
Last updated
27 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 26439406

  • 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.

    PubMed 29198932

  • 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.

    PubMed 28267751

  • 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.

    PubMed 24761164

  • 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.

    PubMed 31305415

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture and TENS in people with Osteoarthritis, Knee, run by Universitat de Girona.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tomás Tegiacchi (0034676364399, tomasjtg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Pain at post intervention (time frame: At the end of the intervention, at the 4th week of the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05096806, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.

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