Clinical trial NCT01188837: Comparing Manipulation, Rehabilitation and Combination of the Two in the Treatment of Knee Osteoarthritis
Official title: The Relative Effectiveness of Three Full Kinetic Chain Treatment Protocols for Osteoarthritis of the Knee: Manual Therapy, Rehabilitation and a Combination Thereof
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, Knee
Manipulation Therapy
Lead sponsor: Cleveland Chiropractic College
Sponsor class: OTHER
Collaborators: name: Durban University of Technology
name: Murdoch University
First posted: 2010-08-26
Enrollment: 144
Sex: ALL
Minimum age (years): 38
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 risk. Manipulative therapy for KOA gives pain relief and increased function. However, research suggests addition of manipulative and soft tissue therapy (to the entire kinetic chain: lumbosacral, sacroiliac, hip, knee, ankle and foot joints), may give a better outcome. Exercise therapy is considered an effective and standard care for KOA.

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% have these x-ray changes. KOA may be the largest cause of decreased mobility, function, disability and pain in people aged ≥ 50 in the US. KOA causes 30% \> age 60 to experience decreased social activities of daily living, increased cardiovascular risk, increased fall risk and secondary depression. Overall KOA prevalence is 4% in young adults, 85% in those \> 75. Beyond great personal suffering - in the US, annual financial costs associated with OA were $60 billion per year in 2000 and, for all OA and rheumatic disease $128 billion in 2003. Estimates in 2005 were 27 million people suffer significantly due to OA and by 2020 in the US and other developed nations \> 12 million will suffer serious, and 19 million minor to moderate work or activity related disability from OA and KOA, with the highest prevalence expected in women.

Medical care commonly prescribed for KOA is lifestyle accommodation (decreased activity, a cane, high chairs and toilet seats, etc), non-steroidal anti-inflammatory drugs (NSAIDS), anti-arthritics, steroids, various and sundry prescription and non-prescription oral and topical medications and exercise. Randomized controlled trials (RCTS) support exercise for KOA treatment, proven superior to placebo. At least 50% (and periodically up to 90 percent) of KOA patients regularly use NSAIDs. Frequent minor but intermittently serious gastrointestinal and cardiovascular adverse reactions to chronic use of NSAIDS occur, and there is evidence that using exercise/rehabilitation with or without manipulative (MAN) therapy may give safer, similar or equivalent relief. Supported by earlier RCTs, MAN therapy with and without soft tissue and exercise therapy for KOA appears superior to placebo and equal or superior to exercise. Although Chiropractic has conducted and published two RCTs of manipulative therapy for KOA, the profession has not yet conducted an RCT with combined full kinetic chain MAN therapy, soft tissue and rehabilitation versus standard care (rehabilitation or exercise therapy) nor studied optimum dose for various patients. 1). in effect only 1 study of such combined care (MAN therapy, soft tissue and rehabilitation or exercise therapy) exists; 2) more studies of MAN therapy combined with rehabilitation are needed to establish: a). equivalent or b). superior treatment efficacy with full kinetic chain therapy and to c). use 'dose time to response' techniques to study the optimum number of treatments for various patients and (to help determine who will respond and will not respond and why) and d)collect data to develop future cost effective research.

Significant morbidity and occasional mortality from NSAID and drug-related complications and surgery; difficulty in obtaining compliance with prolonged exercise protocols; apparent similar, equivalent or superior outcomes (manipulative therapy with and without, but possibly superior with, combined rehabilitation) in pain relief, mobility and function; the possibility of decreasing falls with their appalling sequela in morbidity, mortality and expense; justifies further research into multimodal manipulative therapy for treatment of KOA. Data suggests such full kinetic chain MAN therapy with rehabilitation may give earlier, effective, less costly outcomes and reflects a common clinical chiropractic approach to KOA. In addition to the knee joint, KOA disability has been demonstrated to be significantly worsened by hip joint dysfunction, for example restricted hip flexion increases KOA pain and dysfunction; and there are similar associations throughout the full kinetic chain for example lumbosacral spine joint dysfunction may increase knee pain and dysfunction. Manipulative therapy applied appropriately to the full, kinetic chain (to the full axial and appendicular skeleton -the spine and extremities) combined with rehabilitation may be a superior treatment for knee OA.

Eligibility criteria: Inclusion Criteria:

1. Knee pain and crepitus with active motion and morning stiffness ≤ 30 min ages ≥ 38 and ≤ 80
2. Knee pain and crepitus with active motion and morning stiffness \>30 minutes and boney enlargement ages ≥ 38 and ≤ 80
3. 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)
4. 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)
5. 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 Criteria:

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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Primary outcomes:
measure: McMaster Overall Therapy Effectiveness Tool
timeFrame: 15 months
measure: Western Ontario and McMaster Universities Osteoarthritis index
timeFrame: 15 months
Secondary outcomes:
measure: Range of Motion
timeFrame: 15 months
measure: One Leg Standing Test
timeFrame: 15 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cleveland Chiropractic College Health Center
state: California
city: Durban
country: South Africa
facility: Durban University of Technology
Study officials:
affiliation: Cleveland Chiropractic College
name: James W Brantingham, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deyle GD, Allison SC, Matekel RL, Ryder MG, Stang JM, Gohdes DD, Hutton JP, Henderson NE, Garber MB. Physical therapy treatment effectiveness for osteoarthritis of the knee: a randomized comparison of supervised clinical exercise and manual therapy procedures versus a home exercise program. Phys Ther. 2005 Dec;85(12):1301-17.
citation: Pollard H, Ward G, Hoskins W, Hardy K. The effect of a manual therapy knee protocol on osteoarthritic knee pain: a randomised controlled trial. J Can Chiropr Assoc. 2008 Dec;52(4):229-42.
citation: Hoeksma HL, Dekker J, Ronday HK, Heering A, van der Lubbe N, Vel C, Breedveld FC, van den Ende CH. Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial. Arthritis Rheum. 2004 Oct 15;51(5):722-9. doi: 10.1002/art.20685.
citation: Fish D, Kretzmann H, Brantingham JW, Globe G, Korporaal C, Moen J. A Randomized Clinical Trial to Determine the Effect of Combining a Topical Capsaicin Cream and Knee-Joint Mobilization in the Treatment of Osteoarthritis of the Knee. Journal of the American Chiropractic Association 8-23, August 2008.