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

Osteoarthritis, Knee Clinical Trial

— EATOAK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299713
• Other study ID #: ACU-001
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: Hospital Son Llatzer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Spain	Son LLàtzer Hospital	Palma	Balearic Islands
Spain	Son Llatzer University Hospital	Palma	Balear Islands

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Son Llatzer

Country where clinical trial is conducted

Spain, 

References & Publications (9)

Ahsin S, Saleem S, Bhatti AM, Iles RK, Aslam M. Clinical and endocrinological changes after electro-acupuncture treatment in patients with osteoarthritis of the knee. Pain. 2009 Dec 15;147(1-3):60-6. doi: 10.1016/j.pain.2009.08.004. Epub 2009 Sep 18. — View Citation

Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med. 2004 Dec 21;141(12):901-10. — View Citation

Kwon YD, Pittler MH, Ernst E. Acupuncture for peripheral joint osteoarthritis: a systematic review and meta-analysis. Rheumatology (Oxford). 2006 Nov;45(11):1331-7. Epub 2006 Aug 27. Review. — View Citation

Manheimer E, Cheng K, Linde K, Lao L, Yoo J, Wieland S, van der Windt DA, Berman BM, Bouter LM. Acupuncture for peripheral joint osteoarthritis. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD001977. doi: 10.1002/14651858.CD001977.pub2. Review. — View Citation

Sangdee C, Teekachunhatean S, Sananpanich K, Sugandhavesa N, Chiewchantanakit S, Pojchamarnwiputh S, Jayasvasti S. Electroacupuncture versus diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial. BMC Complement Altern Med. 2002 Mar 21;2:3. — View Citation

Selfe TK, Taylor AG. Acupuncture and osteoarthritis of the knee: a review of randomized, controlled trials. Fam Community Health. 2008 Jul-Sep;31(3):247-54. doi: 10.1097/01.FCH.0000324482.78577.0f. Review. — View Citation

Vas J, Méndez C, Perea-Milla E, Vega E, Panadero MD, León JM, Borge MA, Gaspar O, Sánchez-Rodríguez F, Aguilar I, Jurado R. Acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee: randomised controlled trial. BMJ. 2004 Nov 20;329(7476):1216. Epub 2004 Oct 19. — View Citation

White A, Foster NE, Cummings M, Barlas P. Acupuncture treatment for chronic knee pain: a systematic review. Rheumatology (Oxford). 2007 Mar;46(3):384-90. Epub 2007 Jan 10. Review. — View Citation

Witt C, Brinkhaus B, Jena S, Linde K, Streng A, Wagenpfeil S, Hummelsberger J, Walther HU, Melchart D, Willich SN. Acupuncture in patients with osteoarthritis of the knee: a randomised trial. Lancet. 2005 Jul 9-15;366(9480):136-43. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in visual analogue scale (VAS) and the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index pain subscale	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)	baseline and the completion of treatment at 12 weeks.
Secondary	Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey	patient-perceived quality of life	at 1 month
Secondary	Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey	patient-perceived quality of life	at 3 months
Secondary	Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey	patient-perceived quality of life	at 6 months
Secondary	Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey	patient-perceived quality of life	up to 1 year
Secondary	Change from baseline in plasma cortisol and beta-endorphins levels	analysis of blood samples	at 1 month
Secondary	Change from baseline in plasma cortisol and beta-endorphins levels	analysis of blood samples	at 3 months
Secondary	Change from baseline in plasma cortisol and beta-endorphins levels	analysis of blood samples	at 6 months
Secondary	Change from baseline in plasma cortisol and beta-endorphins levels	analysis of blood samples	up to 1 year
Secondary	Change from Baseline in Goldberg Depression and Anxiety scales	measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al. will be used	at 1 month
Secondary	Change from Baseline in Goldberg Depression and Anxiety scales	measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al. will be used	at 3 months
Secondary	Change from Baseline in Goldberg Depression and Anxiety scales	measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al. will be used	at 6 months
Secondary	Change from Baseline in Goldberg Depression and Anxiety scales	measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al. will be used	up to 1 year
Secondary	Change from baseline in WOMAC index	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.	at 1 month
Secondary	Change from baseline in WOMAC index	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.	at 6 months
Secondary	Change from baseline in WOMAC index	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.	up to 1 year
Secondary	Changes in baseline use of medication	EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire	at 1 month
Secondary	Changes in baseline use of medication	EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire	at 3 months
Secondary	Changes in baseline use of medication	EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire	at 6 months
Secondary	Changes in baseline use of medication	EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire	up to 1 year
Secondary	Change from baseline in a visual analogue scale (VAS)	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)	at 1 month
Secondary	Change from baseline in a visual analogue scale (VAS)	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)	at 6 months
Secondary	Change from baseline in a visual analogue scale (VAS)	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)	up to 1 year