Clinical Assessment of Two Manipulative Protocols in Treatment of Hip Osteoarthritis

NCT00523172 | Unknown Early Phase 1

• 1 other identifier: IRB08102007
• Study Type: interventional
• Target: 120
• Locations: 3 countries
• Sites: 3

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.

Conditions

Osteoarthritis, Hip

Keywords

Chiropractic Manipulation

Outcome Measures

Primary Outcomes (4)

• 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.

  Nine Months

• Establish protocols for long-term surveillance of OAH in chiropractic patients.

  2 years

• integrate a clinical research program with a teaching clinic system.

  Two years

• Collect and compare protocol outcome data. Primary outcome measure will be: a 6 point Likert scale.

  2 years

Study Arms (3)

Group A

ACTIVE COMPARATOR

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

Group B

ACTIVE COMPARATOR

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

Supportive Care

OTHER

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

Interventions

manual or manipulative therapy PROCEDURE

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.

Group A

Manual / Manipulative Therapy PROCEDURE

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.)

Group B

Supportive Care PROCEDURE

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.

Supportive Care

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hip pain and \< 15° internal rotation and \< than 115° flexion or
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Cleveland Chiropractic College: lead
• Durban University of Technology: collaborator
• Macquarie University, Australia: collaborator

Study Sites (3)

Cleveland Chiropractic College Health Center

Los Angeles, California, 90004, United States

Location

Macquarie University

Sydney, Australia

Location

Durban University of Technology

Durban, South Africa

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Musculoskeletal Manipulations; Palliative Care

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• James Brantingham, D.C., Ph.D.

  Cleveland Chiropractic College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 29, 2007
• First Posted: August 31, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 19, 2010

Record last verified: 2010-07

Locations

US (1); AU (1); ZA (1)