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

This study has been completed.
Sponsor:
Information provided by:
National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier:
NCT01398930
First received: July 20, 2011
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Knee Osteoarthritis
Other: acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National and Kapodistrian University of Athens:

Primary Outcome Measures:
  • primary outcome measure was the Western Ontario and McMaster Universities (WOMAC) index Version VA3.1 and its three subscales (pain, stiffness, and physical function) [ Time Frame: end of the treatment week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Western Ontario and McMaster Universities (WOMAC) scales [ Time Frame: weeks 4, 12 ] [ Designated as safety issue: No ]
  • Visual Analogue Scale (VAS) (0-100) [ Time Frame: end of weeks 4, 8, and 12 ] [ Designated as safety issue: No ]
  • SF-36v2 health survey [ Time Frame: end of week 8 ] [ Designated as safety issue: No ]
  • Pain Test™ FDK 20 Algometer [ Time Frame: end of weeks 4, 8, and 12 ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: September 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group I was treated with etoricoxib Other: acupuncture
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.
Active Comparator: Group II was treated with acupuncture and etoricoxib Other: acupuncture
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.
Sham Comparator: Group III was treated with sham acupuncture and etoricoxib. Other: acupuncture
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398930

Locations
Greece
National and Kapodistrian University Medical School
Athens, Greece, 11527
Sponsors and Collaborators
National and Kapodistrian University of Athens
  More Information

Publications:
Responsible Party: Christos I. Mavrommatis, MD,Resident of Rheumatology, Rheumatology Department, General Hospital Of Athens "Evaggelismos"., National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT01398930     History of Changes
Other Study ID Numbers: M-127
Study First Received: July 20, 2011
Last Updated: July 20, 2011
Health Authority: Greece: Ethics Committee

Keywords provided by National and Kapodistrian University of Athens:
acupuncture; knee osteoarthritis; adjunctive therapy; chronic pain; algometer; etoricoxib.

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014