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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05096806
• Other study ID #: CEBRU0021-21
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: October 2021
• Source: Universitat de Girona
• Contact: Tomás Tegiacchi
• Phone: 0034676364399
• Email: tomasjtg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Acupuncture
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.

Device:
• TENS
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitat de Girona

References & Publications (5)

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. Review. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Pain at post intervention	Pain will be assessed using the visual analogue scale (VAS)	At the end of the intervention, at the 4th week of the study
Primary	Change from Baseline Knee function at postintervention	Knee function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	At the end of the intervention, at the 4th week of the study
Primary	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.	At the end of the intervention, at the 4th week of the study
Secondary	Change from Baseline Pain at 4 months	Pain will be assessed using the visual analogue scale (VAS)	16 weeks afther the end of the intervention, at the 20th week of the study
Secondary	Change from Baseline Knee function at 4 months	Knee function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	16 weeks afther the end of the intervention, at the 20th week of the study
Secondary	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.	16 weeks afther the end of the intervention, at the 20th week of the study
Secondary	Drug intake postintervention	Rescue drug intake will be collected in the data collection notebooks	through study completion, an average of 1 year
Secondary	Adverse events postintervention	Any adverse event related with the treatments will be will be noted in a collection sheet.	through study completion, an average of 1 year