Clinical Assessment of Two Manipulative Protocols in Treatment of Hip Osteoarthritis - Full Text View

Sponsor:	Cleveland Chiropractic College
Collaborators:	Durban University of Technology South Africa Macquarie University, Australia
Information provided by:	Cleveland Chiropractic College
ClinicalTrials.gov Identifier:	NCT00523172

Purpose

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

Condition	Intervention	Phase
Osteoarthritis, Hip	Procedure: manual or manipulative therapy Procedure: Manual / Manipulative Therapy Procedure: Supportive Care	Phase 0

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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by Cleveland Chiropractic College:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Establish protocols for long-term surveillance of OAH in chiropractic patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
integrate a clinical research program with a teaching clinic system. [ Time Frame: Two years ] [ Designated as safety issue: No ]
Collect and compare protocol outcome data. Primary outcome measure will be: a 6 point Likert scale. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Group A 1) Group A will receive 9 manipulative therapy treatments (adjustments) to one area: the hip with pre-manipulative static and post active-assisted stretch of tight hip muscles. After the last (or 9th) treatment these patients will receive general advice and recommendations on managing HOA and how to gently and safely increase general exercise. • Based on a previous trial, Group A treatment appears superior than placebo. There will be a 3, 6 and 9 month follow up.	Procedure: manual or manipulative therapy Active comparator will receive 9 treatments of manual or manipulative therapy to the hip (HVLA hip manipulations per protocol 1) with pre-manipulative static and post manipulative active-assisted stretch of hip muscles after each manipulation.
Active Comparator: Group B 2) Group B will receive 9 treatments with manipulative therapy treatments (adjustments) to the entire kinetic chain (five areas): the lumbosacral, sacroiliac, hip, knee, ankle and foot joints with pre-manipulative static and post active-assisted stretch of tight hip muscles. There will be a 3, 6 and 9 month follow up.	Procedure: Manual / Manipulative Therapy Active comparator will receive 9 treatments of manual or manipulative therapy to the lumbosacral, sacroiliac, hip and knee, ankle and foot joints (HVLA and Grades I-IV mobilization per protocol 2) stretching and exercise.)
Supportive Care Supportive Care 3) Groups A and B will receive supportive care after the 9th visit consisting of (up to a maximum of) 6 visits, PRN or as needed, until the 9 month follow up. This is to see if peak gains may be maintained (as noted in the previous trial) throughout the follow up period. Enrolled subjects will commonly receive 2 treatments per week (occasionally, less or more than 1 to 2 treatments per week due to (College or University) semester breaks, exams, clinic closures and so forth) until 9 treatments are completed.	Procedure: Supportive Care Supportive Care 3) Groups A and B will receive supportive care after the 9th visit consisting of (up to a maximum of) 6 visits, PRN or as needed, until the 9 month follow up. This is to see if peak gains may be maintained (as noted in the previous trial) throughout the follow up period. Enrolled subjects will commonly receive 2 treatments per week (occasionally, less or more than 1 to 2 treatments per week due to (College or University) semester breaks, exams, clinic closures and so forth) until 9 treatments are completed.

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Eligibility

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hip pain and < 15° internal rotation and < than 115° flexion or
Hip pain with >15° internal rotation causing hip pain and morning stiffness ≤ 60 minutes Note: Hip x-rays will be taken in each case (after a clinical diagnosis of hip osteoarthritis has been made and to rule out and exclude severe pathology) to determine grades (0-4) Kellgren Lawrence x-ray scale. If medically necessary, lumbosacral pelvic x-rays will be obtained-- see exclusions below)
Age ≥ 60 and ≤ 85 years of age
Diagnosis of concurrent subluxation complex

* Diagnosis of subluxation complex (aka segmental joint dysfunction) will be supported throughout using the PART(S) system.
Additionally, OAH patients, who demonstrate a + One Legged Standing Test (OLST) and + Berg Balance Scale (BBS) will be monitored as a subgroup (with OLST and BBS) at all assessments.

Exclusion Criteria:

General and internal medical disorders such as:

Significant visual disorders
Severe vestibular disorders (i.e., Meniere's)
Neurological (including Alzheimer's and other degenerative brain and mental disorders, disease and dysfunction) peripheral sensory disorders (severe insulin dependent diabetes)
Hip joint replacement
RA
Instability
Fracture/ and severe osteoporosis
Frank avascular necrosis with or without moderate or severe deformity
Lumbar herniated disc and injury
Severe balance and proprioception problems (i.e., inability to stand with and/or without marked spinal or hip deformity) etc.
Symptoms (moderate to severe) in both hips.
Marked or severe fear of chiropractic adjustments/manipulative and or exercise procedures.
Breaks for treatment longer than 3-4 weeks depending on each circumstance or merit may be construed as non-compliance and may be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523172

Locations

United States, California
Cleveland Chiropractic College Health Center
Los Angeles, California, United States, 90004
Australia
Macquarie University
Sydney, Australia
South Africa
Durban University of Technology
Durban, South Africa

Sponsors and Collaborators

Cleveland Chiropractic College

Durban University of Technology South Africa

Macquarie University, Australia

Investigators

Principal Investigator:

James Brantingham, D.C., Ph.D.

Cleveland Chiropractic College

More Information

No publications provided

Responsible Party:	James W Brantingham, DC, PhD, Cleveland Chiropractic College
ClinicalTrials.gov Identifier:	NCT00523172 History of Changes
Other Study ID Numbers:	IRB08102007
Study First Received:	August 29, 2007
Last Updated:	July 16, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Cleveland Chiropractic College:

Chiropractic Manipulation

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Hip
Arthritis

Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 12, 2012