Clinical trial NCT05096806: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Acupuncture
Osteoarthritis, Knee
Lead sponsor: Universitat de Girona
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from Baseline Pain at post intervention
timeFrame: At the end of the intervention, at the 4th week of the study
measure: Change from Baseline Knee function at postintervention
timeFrame: At the end of the intervention, at the 4th week of the study
measure: Change from Baseline Quality of life at postintervention
timeFrame: At the end of the intervention, at the 4th week of the study
Secondary outcomes:
measure: Change from Baseline Pain at 4 months
timeFrame: 16 weeks afther the end of the intervention, at the 20th week of the study
measure: Change from Baseline Knee function at 4 months
timeFrame: 16 weeks afther the end of the intervention, at the 20th week of the study
measure: Change from Baseline Quality of life at 4 months
timeFrame: 16 weeks afther the end of the intervention, at the 20th week of the study
measure: Drug intake postintervention
timeFrame: through study completion, an average of 1 year
measure: Adverse events postintervention
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
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.
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.