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

NCT02299713 | Completed

• 1 other identifier: ACU-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Osteoarthritis, Knee

Keywords

acupuncture; knee pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey

  at 1 month

• Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey

  at 3 months

• Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey

  at 6 months

• Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey

  up to 1 year

• Change from baseline in plasma cortisol and beta-endorphins levels

  at 1 month

Study Arms (2)

placebo/sham acupuncture

SHAM COMPARATOR

There are different types of controls used in acupuncture trials. We used the control described as sham and by some as minimal acupuncture. This group had the same schedule as the electro-acupuncture group. Sham acupuncture was administered, with the same duration and frequency and by the same specialist who performed the non-sham acupuncture. Retractable needles were placed into small adhesive cylinders, so that the needles were supported but did not perforate the skin. The acupuncturist placed the needles at the same points as the non-sham group and used the same pairs of electrodes to simulate the electrical connection.

Device: Electroacupuncture

Electroacupuncture

ACTIVE COMPARATOR

The electro-acupuncture device was a biphasic pulse generator. It was used with maximum tolerable intensity of current and a frequency of 3 Hz. The points were selected according to the Traditional Chinese Medicine meridian theory to treat knee pain. The points selected were local points St 34, St 35, St 36,Liv 8, Sp 10. One distal point St 44.A total of six needles were inserted into each leg by the acupuncturist (the out come measures were not specifically targeted to whether the patient had one or both knees involved). All patients belonging to this group experienced a De Qi sensation, which is a tingling and numbness sensation upon needling of specific points.

Device: Electroacupuncture

Interventions

Electroacupuncture DEVICE

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.

Electroacupuncture; placebo/sham acupuncture

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Son Llatzer: lead

Study Sites (2)

Son Llatzer University Hospital

Palma, Balear Islands, 07198, Spain

Location

Son LLàtzer Hospital

Palma, Balearic Islands, 07198, Spain

Location

Related Publications (10)

• 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.

  PMID: 19766392 BACKGROUND

• Vas J, Mendez C, Perea-Milla E, Vega E, Panadero MD, Leon JM, Borge MA, Gaspar O, Sanchez-Rodriguez 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. doi: 10.1136/bmj.38238.601447.3A. Epub 2004 Oct 19.

  PMID: 15494348 BACKGROUND

• 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. doi: 10.1186/1472-6882-2-3.

  PMID: 11914160 BACKGROUND

• 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. doi: 10.1016/S0140-6736(05)66871-7.

  PMID: 16005336 BACKGROUND

• 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. doi: 10.7326/0003-4819-141-12-200412210-00006.

  PMID: 15611487 BACKGROUND

• 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.

  PMID: 18552606 BACKGROUND

• 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. doi: 10.1093/rheumatology/kel207. Epub 2006 Aug 27.

  PMID: 16936326 BACKGROUND

• 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. doi: 10.1093/rheumatology/kel413. Epub 2007 Jan 10.

  PMID: 17215263 BACKGROUND

• 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;2010(1):CD001977. doi: 10.1002/14651858.CD001977.pub2.

  PMID: 20091527 BACKGROUND

• Mata J, Cabrera S, Sanchis P, Valenti P, Hernandez P, Fortuny R, Lirola S, Aguilar JL. Electro-acupuncture for treatment of knee pain from osteoarthritis and the possible endocrinology changes: a study protocol for a randomized controlled trial. Trials. 2015 Jun 3;16:248. doi: 10.1186/s13063-015-0766-2.

  PMID: 26037626 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Javier Mata, M.D.

  Anaesthesia Department, Son Llàtzer University Hospital. Palma de Mallorca. Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Section of Anesthesiology and Reanimation Department

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 24, 2014
• Study Start: January 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: November 1, 2017
• Last Updated: April 7, 2020

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)