Clinical Trial: Clinical Assessment of Two Manipulative Protocols in Treatment of Hip Osteoarthritis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized Clinical Trial Comparing Two Manipulative Protocols to Assess Changes in Pain, ROM, Quality of Life, Cost and Risk for Falls in Subjects With Hip Osteoarthritis

Brief Summary: Purpose of this study is to examine the effect of chiropractic adjusting (manipulative therapy) and rehabilitation on hip osteoarthritis (hip OA) in older adults.

Detailed Summary:

Patients seek treatment from chiropractors for (OA). OA is the fifth most reported and treated disorder in medical practice. Osteoarthritis of the hip (OAH), a subset, affects ≥12 million American adults and leads to pain, loss of mobility, decreased: function, strength, activities of daily living, quality of life and is a significant risk factor for falls. Medical care prescribed for OAH is lifestyle accommodation (a cane, high chairs and toilet seats, etc), non-steroidal anti-inflammatory drugs (NSAIDS), anti-arthritics, steroids, various and sundry prescription and non-prescription medications and exercise. Randomized controlled trials (RCTS) support exercise for knee OA (KOA) treatment, proven superior to placebo, less so for OAH. Ninety-two percent of patients with OAH use NSAIDS. Frequent minor and intermittently serious adverse reactions to chronic use of NSAIDS and evidence that manipulative/manual therapy (MAN) and exercise/rehabilitation therapy may give equivalent relief, suggests NSAIDS should be infrequently used. Supported by an earlier RCT that demonstrated manual, soft tissue and exercise therapy for KOA superior to placebo; later this protocol was found superior to exercise. A similar multimodal (multimodal = MAN with 2 or more combined treatments) 2004 RCT compared exercise protocol versus MAN combined with passive and active stretch for OAH. Early, superior relief and function was achieved with multimodal MAN. This suggests multimodal MAN (manipulative) therapy may be a superior treatment.

In studies that followed multimodal MAN over a year (without minimal, later, PRN or supportive treatment given) all treatment benefits begin to decrease toward a similar mean). One feature frequently inherent in previous trial design has no availability of additional brief treatment rounds subsequent to a short course of interventional therapy. Researchers typic
Sponsor: Cleveland Chiropractic College

Current Primary Outcome:

  • Recruit a pool of HOA patients from senior centers, the local community, medical and chiropractic clinics, and through advertising in collaboration with other Universities/Colleges or Schools. [ Time Frame: Nine Months ]
  • Establish protocols for long-term surveillance of OAH in chiropractic patients. [ Time Frame: 2 years ]
  • integrate a clinical research program with a teaching clinic system. [ Time Frame: Two years ]
  • Collect and compare protocol outcome data. Primary outcome measure will be: a 6 point Likert scale. [ Time Frame: 2 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Cleveland Chiropractic College

Dates:
Date Received: August 29, 2007
Date Started: October 2007
Date Completion: October 2010
Last Updated: July 16, 2010
Last Verified: July 2010