Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00523172




Registration number
NCT00523172
Ethics application status
Date submitted
29/08/2007
Date registered
31/08/2007
Date last updated
19/07/2010

Titles & IDs
Public title
Clinical Assessment of Two Manipulative Protocols in Treatment of Hip Osteoarthritis
Scientific 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
Secondary ID [1] 0 0
IRB08102007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Hip 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - manual or manipulative therapy
Treatment: Surgery - Manual / Manipulative Therapy
Treatment: Surgery - Supportive Care

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.

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.

Other: 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.


Treatment: Surgery: 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.

Treatment: Surgery: 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.)

Treatment: Surgery: 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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Nine Months
Primary outcome [2] 0 0
Establish protocols for long-term surveillance of OAH in chiropractic patients.
Timepoint [2] 0 0
2 years
Primary outcome [3] 0 0
integrate a clinical research program with a teaching clinic system.
Timepoint [3] 0 0
Two years
Primary outcome [4] 0 0
Collect and compare protocol outcome data. Primary outcome measure will be: a 6 point Likert scale.
Timepoint [4] 0 0
2 years

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2010
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Macquarie University - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
South Africa
State/province [2] 0 0
Durban

Funding & Sponsors
Primary sponsor type
Other
Name
Cleveland Chiropractic College
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Durban University of Technology
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Macquarie University, Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Brantingham, D.C., Ph.D.
Address 0 0
Cleveland Chiropractic College
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00523172