Clinical trial NCT01039337: Conservative Treatment for Hip Osteoarthritis
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 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Hip
Keywords: osteoarthritis
manual therapy
manipulation
hip school
chiropractic
patient education
Lead sponsor: Nordic Institute of Chiropractic and Clinical Biomechanics
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Odense University Hospital
name: Foundation for Chiropractic Research and Post Graduate Education
name: Region of Southern Denmark
name: The Danish Rheumatism Association
First posted: 2009-12-24
Enrollment: 118
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* patients referred from general practitioner, chiropractor or orthopaedic surgeon
* unilateral hip pain of minimum 3 months' duration
* radiology criteria for hip OA: joint space width (JSW) \< 2.0 mm or a side difference in JSW of \> 10%
* adequate mastering of the Danish language to complete instructions and questionnaires

Exclusion Criteria:

* inflammatory joint disease
* previous hip or knee alloplastic
* secondary arthritis due to hip fracture or infection
* bilateral hip pain
* hip dysplasia with a CE angle \> 25 degrees and an AA angle \> 10 degrees
* low back pain which dominates over the hip pain
* malignant disease
* patients with paresis or paralysis after neuromuscular, cerebrovascular or polyneuropathic disease
* hip pain resulting from labral tear, bursitis and/or snapping hip syndrome
* polyarthritis
* received manual treatment for the hip within the last year

Primary outcomes:
measure: Pain: Numerical pain scale
timeFrame: Baseline, 6 weeks, 3 months, 1 year
Secondary outcomes:
measure: Hip Disability and Osteoarthritis Outcome Score
timeFrame: Baseline, 6 weeks, 3 months, 1 year
measure: General improvement experienced by patient - "Global Assessment"
timeFrame: Baseline, 6 weeks, 3 months, 1 year
measure: Quality of life: EQ-5D
timeFrame: Baseline, 6 weeks, 3 months, 1 year
measure: Passive hip range of motion
timeFrame: Baseline, 6 weeks, 3 months, 1 year
measure: Hip surgery up to one year after baseline
timeFrame: Baseline, 6 weeks, 3 months, 1 year
measure: Use of pain medication
timeFrame: Baseline, 6 weeks, 3 months, 1 year
measure: Patient Specific Hip Disability
timeFrame: Baseline, 6 weeks, 3 months, 1 year
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Ortopaedic Surgery and Traumatology, Odense University Hospital
state: DK
Study officials:
affiliation: Nordic Institute of Chiropractic and Clinical Biomechanics
name: Erik Poulsen, DC, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poulsen E, Hartvigsen J, Christensen HW, Roos EM, Vach W, Overgaard S. Patient education with or without manual therapy compared to a control group in patients with osteoarthritis of the hip. A proof-of-principle three-arm parallel group randomized clinical trial. Osteoarthritis Cartilage. 2013 Oct;21(10):1494-503. doi: 10.1016/j.joca.2013.06.009. Epub 2013 Jun 21.
citation: Poulsen E, Christensen HW, Roos EM, Vach W, Overgaard S, Hartvigsen J. Non-surgical treatment of hip osteoarthritis. Hip school, with or without the addition of manual therapy, in comparison to a minimal control intervention: protocol for a three-armed randomized clinical trial. BMC Musculoskelet Disord. 2011 May 4;12:88. doi: 10.1186/1471-2474-12-88.