Comparing Manipulation, Rehabilitation and Combination of the Two in the Treatment of Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

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.
    

Intervention name(s): Full Kinetic Chain Manipulative Therapy; Full Kinetic Chain Rehabilitation; Full Kinetic Chain Manipulative Therapy with Rehabilitation
Intervention type(s): Other; Other; Other
Intervention description(s): Treatment will focus on restoring knee flexion and extension by lesser grades of mobilization and patellar mobilization along with careful high velocity low amplitude axial elongation of the knee joint.
Additionally, manipulative therapy will be applied where needed to the full kinetic chain using diversified techniques, such as HVLA manipulation or mobilization.
This group will receive a total of 6 treatments over a 3 week period. Outcome measures will be taken at baseline, prior to the 4th treatment and at the one week follow-up. A 3 month follow-up will be done by mail, phone or email.; Rehabilitative therapy includes exercises, focused soft tissue treatment and stretch to the knee and the full kinetic chain where needed based upon functional assessment. Also included; patient advice, education and home exercise recommendations for managing their KOA.
This group will receive a total of 6 treatments over a 3 week period. Outcome measures will be taken at baseline, prior to the 4th treatment and at the one week follow-up. A 3 month follow-up will be done by mail, phone or email.
The rehabilitative therapy group will be required to attend the initial treatment/training, the 4th visit and 1 week follow-up. Treatments 2, 3, 5 and 6 are considered optional; they may be done at home; This arm is a combination of the manipulative therapy arm and the rehabilitative therapy arm.
This group receives 6 treatments over a 3 week period with a one week follow-up on site and a 3 month follow-up by mail, phone or email.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis, Knee; Manipulation Therapy