Acupuncture as an Adjunctive Therapy to the Pharmacological Treatment in Patients With Chronic Pain in Osteoarthritis of the Knee: a Three Armed Randomized Placebo Controlled Trial

NCT01398930 | Completed

• 1 other identifier: M-127
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the efficacy of acupuncture as an adjunctive therapy to pharmacological treatment of chronic pain due to knee osteoarthritis, as well as for, the improvement of physical functioning, reduction of stiffness, and improvement in quality of life. This is a 3-armed single-blinded randomized sham-controlled trial, comparing acupuncture along with pharmacological treatment, sham acupuncture including pharmacological treatment, and pharmacological treatment alone. One-hundred and twenty patients with knee osteoarthritis were randomly allocated to 3 groups. Group I was treated with etoricoxib, Group II was treated with acupuncture and etoricoxib, and Group III was treated with sham acupuncture and etoricoxib.

Conditions

Knee Osteoarthritis

Keywords

acupuncture; knee osteoarthritis; adjunctive therapy; chronic pain; algometer; etoricoxib.

Outcome Measures

Primary Outcomes (1)

• primary outcome measure was the Western Ontario and McMaster Universities (WOMAC) index Version VA3.1 and its three subscales (pain, stiffness, and physical function)

  end of the treatment week 8

Secondary Outcomes (4)

• Western Ontario and McMaster Universities (WOMAC) scales

  weeks 4, 12

• Visual Analogue Scale (VAS) (0-100)

  end of weeks 4, 8, and 12

• SF-36v2 health survey

  end of week 8

• Pain Test™ FDK 20 Algometer

  end of weeks 4, 8, and 12

Study Arms (3)

Group I was treated with etoricoxib

ACTIVE COMPARATOR

Other: acupuncture

Group II was treated with acupuncture and etoricoxib

ACTIVE COMPARATOR

Other: acupuncture

Group III was treated with sham acupuncture and etoricoxib.

SHAM COMPARATOR

Other: acupuncture

Interventions

acupuncture OTHER

This is a 3-armed single-blinded randomized sham-controlled trial, comparing acupuncture along with pharmacological treatment, sham acupuncture including pharmacological treatment, and pharmacological treatment alone.

Group I was treated with etoricoxib; Group II was treated with acupuncture and etoricoxib; Group III was treated with sham acupuncture and etoricoxib.

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American College of Rheumatology criteria for diagnosis of knee osteoarthritis
• Kellgren-Lawrence (radiologic criterion) score of at least 2
• chronic pain in the knee joint for longer than 3 months

You may not qualify if:

• intra-articular corticosteroid or hyaluronate injection during the last 3 months
• corticosteroids
• antiplatelet drugs (apart from acetylsalicylic acid 100mg)
• immunosuppressive drugs
• malignancy of any kind
• psychiatric disease
• stroke
• heart attack
• kidney failure
• active gastric or duodenal ulcer, or gastrorrhagia
• other forms of arthritis
• arthroplasty during the last year
• previous treatment with acupuncture

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

National and Kapodistrian University Medical School

Athens, 11527, Greece

Location

Related Publications (6)

• 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, Singh BB, Lao L, Langenberg P, Li H, Hadhazy V, Bareta J, Hochberg M. A randomized trial of acupuncture as an adjunctive therapy in osteoarthritis of the knee. Rheumatology (Oxford). 1999 Apr;38(4):346-54. doi: 10.1093/rheumatology/38.4.346.

  PMID: 10378713 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

• Melchart D, Weidenhammer W, Streng A, Reitmayr S, Hoppe A, Ernst E, Linde K. Prospective investigation of adverse effects of acupuncture in 97 733 patients. Arch Intern Med. 2004 Jan 12;164(1):104-5. doi: 10.1001/archinte.164.1.104. No abstract available.

  PMID: 14718331 BACKGROUND

• Scharf HP, Mansmann U, Streitberger K, Witte S, Kramer J, Maier C, Trampisch HJ, Victor N. Acupuncture and knee osteoarthritis: a three-armed randomized trial. Ann Intern Med. 2006 Jul 4;145(1):12-20. doi: 10.7326/0003-4819-145-1-200607040-00005.

  PMID: 16818924 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

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 21, 2011
• Study Start: September 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 21, 2011

Record last verified: 2008-07

Locations

GR (1)