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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

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ClinicalTrials.gov Identifier: NCT01398930
Recruitment Status : Completed
First Posted : July 21, 2011
Last Update Posted : July 21, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Knee Osteoarthritis Other: acupuncture

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : September 2007
Primary Completion Date : July 2008
Study Completion Date : July 2008

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  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) [ Time Frame: end of the treatment week 8 ]

Secondary Outcome Measures :
  1. Western Ontario and McMaster Universities (WOMAC) scales [ Time Frame: weeks 4, 12 ]
  2. Visual Analogue Scale (VAS) (0-100) [ Time Frame: end of weeks 4, 8, and 12 ]
  3. SF-36v2 health survey [ Time Frame: end of week 8 ]
  4. Pain Test™ FDK 20 Algometer [ Time Frame: end of weeks 4, 8, and 12 ]

Eligibility Criteria

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: July 21, 2011    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: July 2008

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

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Chronic Pain
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents