Status:
COMPLETED
Comparing Manipulation, Rehabilitation and Combination of the Two in the Treatment of Knee Osteoarthritis
Lead Sponsor:
Cleveland Chiropractic College
Collaborating Sponsors:
Durban University of Technology
Murdoch University
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
38-80 years
Phase:
NA
Brief Summary
Common medical therapies for knee osteoarthritis are patient education, drug and physical therapy, exercise and surgery. These modalities may offer improvement but drugs and surgery carry significant ...
Detailed Description
Patients seek treatment from chiropractors for osteoarthritis (OA) and Knee OA (KOA). Significant KOA impacts 10 % of individuals aged ≥63 particularly with radiographic changes; and by age 65, 80% ha...
Eligibility Criteria
Inclusion
- Knee pain and crepitus with active motion and morning stiffness ≤ 30 min ages ≥ 38 and ≤ 80
- Knee pain and crepitus with active motion and morning stiffness \>30 minutes and boney enlargement ages ≥ 38 and ≤ 80
- Knee pain and no crepitus and boney enlargement ages ≥ 38 and ≤ 80 Note: knee x-rays taken in each case to determine grades (0-4) Kellgren Lawrence x-ray scale - but not required for diagnosis - (and if needed lumbosacral/pelvic, hip, ankle or foot x-rays obtained) see exclusions below)
- Knee pain (mild to moderate) of 1 year duration and age ≥ 38 and ≤ 80 years of age and able to stand and walk (see informed consent)
- Diagnosis of concurrent subluxation/joint dysfunction (S/JD) complex a) Diagnosis of S/JD will be supported throughout using the PART(S) system 6).A patient must have a score of ≥720 mm on the WOMAC to be included (≥30%) 7).Additionally, KOA patients, who are + for the Berg Balance Scale (BBS) will be monitored as a subgroup (with OLST and BBS) at all clinic assessments.
Exclusion
- Rule out: 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), knee and hip joint replacement on side of knee that is treated (case by case otherwise), 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, knee or hip deformity) etc. Symptoms (moderate to severe) in both knees or hips (case by case), etc. Recent history of meniscal or other knee surgery (not less than 6 months). Severe/constant self reported knee crepitus. Severe loss of knee or hip ROM and or severe deformity (in valgus, varus etc) particularly with instability. Severe depression per Beck Depression Index. 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.
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Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT01188837
Start Date
September 1 2010
End Date
October 1 2011
Last Update
August 9 2012
Active Locations (2)
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1
Cleveland Chiropractic College Health Center
Los Angeles, California, United States, 90004
2
Durban University of Technology
Durban, South Africa