Clinical Trial: Conservative Treatment for Hip Osteoarthritis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Conservative Treatment for Hip Osteoarthritis: Effect of Manual Treatment and Hip School on Pain, Disability and Quality of Life - a Single-blinded Randomized Controlled T

Brief Summary: The purpose of the study is to evaluate the effect of manual treatment and a patient education programme for patients without indication for hip surgery.

Detailed Summary:

Hip osteoarthritis (hip OA) is the second most common arthritis of the larger joints and may result in pain and disability and lead to reduced quality of life (QoL). The prevalence of hip OA, in the adult population, > 35 years, is estimated to 4-11% in the western society. In specific countries hip OA affects up to 25% in adults > 60 years. With a growing elder population, these prevalence rates will increase and the demand for cost-effective and safe interventions will increase as well.

International guidelines, 2008, on the management of hip and knee OA recommend a combination of non-pharmacological and pharmacological treatment. For years the majority of interventional research for hip and knee OA has focused on surgery and drugs. Surgery is an option, when pain and disability have reached severe levels, and an increasing group of patients are today looking for other treatment options than drug treatment (pharmacological). In the last 4-6 years, new randomized controlled trials (RCT) have shown promising results with non-pharmacological treatment, such as exercise, patient education, manual therapy and acupuncture.

The purpose of this RCT is to investigate the effect of combining manual treatment and a patient education programme and compare it to a minimal intervention in form of a home stretching programme. It will further investigate the specific effect of manual treatment.


Sponsor: Nordic Institute of Chiropractic and Clinical Biomechanics

Current Primary Outcome: Pain: Numerical pain scale [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]

Original Primary Outcome:

  • Pain: Numerical pain scale [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
  • Disability: Patient Specific Hip Disability [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]


Current Secondary Outcome:

  • Hip Disability and Osteoarthritis Outcome Score [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
  • General improvement experienced by patient - "Global Assessment" [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
  • Quality of life: EQ-5D [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
  • Passive hip range of motion [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
  • Hip surgery up to one year after baseline [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
  • Use of pain medication [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
  • Patient Specific Hip Disability [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]


Original Secondary Outcome:

  • Hip Disability and Osteoarthritis Outcome Score [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
  • General improvement experienced by patient - "Global Assessment" [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
  • Quality of life: EQ-5D [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
  • Passive hip range of motion [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
  • Hip surgery up to one year after baseline [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
  • Use of pain medication [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]


Information By: Nordic Institute of Chiropractic and Clinical Biomechanics

Dates:
Date Received: December 22, 2009
Date Started: October 2008
Date Completion:
Last Updated: March 29, 2016
Last Verified: March 2016