None listed
Conditions
Brief summary
The overall aim of the project is to examine the clinical and cost-effectiveness of utilizing booster sessions (periodic face-to-face follow-up appointments that take place several weeks or months following discharge from the supervised therapy program designed to review the patient's current rehabilitation program, troubleshoot any problems with the program, and make recommendations for program progression or modification) in the delivery of exercise therapy, and supplementing exercise therapy with manual therapy techniques (manually applied treatment techniques such as joint mobilization/manipulation, manual traction, soft tissue manipulations, passive stretching and range of motion). The investigators will do this in a randomized, multi-center, clinical trial. The investigators hypothesize that adding manual therapy techniques will be more clinically effective than exercise alone and that using booster sessions will maintain longer term clinical effects and be more cost-effective than not using booster sessions. This is the NZ study affiliated with the US multi-centre trial ID: NCT01314183: http://clinicaltrials.gov /ct2/show/NCT01314183
Interventions
Exercise therapy (40 minutes) - All participants do this
The program starts with a 10 minute aerobic exercise warm-up (treadmill walking or stationary cycling). Subjects then perform a series of strengthening, stretching, and neuromuscular control activities which are core exercises for the program and mandatory. In addition to the above core exercises, therapists have the option to select additional optional exercise activities, based on the initial examination findings. These exercises will
Exercise therapy (40 minutes) - All participants do this The program starts with a 10 minute aerobic exercise warm-up (treadmill walking or stationary cycling). Subjects then perform a series of strengthening, stretching, and neuromuscular control activities which are core exercises for the program and mandatory. In addition to the above core exercises, therapists have the option to select additional optional exercise activities, based on the initial examination findings. These exercises will address strength or flexibility in the hip, and ankle if impairments are identified in the initial examination. Manual therapy (40 minutes) The manual therapy (MT)techniques are maneuvers that are applied with manual force from the treating therapist. The MT techniques will include a series of accessory motion techniques, manual stretching , and soft tissue manipulation (deep massage to muscles and connective tissues associated with knee function). Core techniques include anterior-posterior and posterior-anterior tibiofemoral translations, superior-inferior and medial-lateral patellofemoral mobilizations, knee flexion and extension mobilizations that may be combined with varus-valgus stresses,medial-lateral tibial rotations, manual stretching of the quadriceps, rectus femoris, hamstring, and gastrocnemius muscles, and soft tissue manipulations of the quadriceps, peri-patellar tissues, hamstring, hip adductors, and gastroc-soleus muscle groups. There are optional MT techniques for the hip, and foot and ankle joints that can be selected by the therapist based on initial examination findings. Booster sessions (40 minutes) Subjects in the standard (comparator) arm receive 12 treatment sessions in 9 weeks. Subjects in the booster (experimental) arm will receive 12 treatment sessions delivered with booster sessions (8 sessions in the first 9 weeks, 2 sessions at 5 months, 1 session at 8 months, and 1 session at 11 months). All treatment sessions are supervised, delivered by physiotherapists to individual patients. This study features a 2x2 factorial design: Factor 1: manual therapy vs no manual therapy Factor 2: booster vs no booster. All participants receive exercise therapy. By random allocation, participants may be assigned manual therapy and/or booster sessions in addition to exercise therapy. NCT01314183 is the ClinicalTrials.gov ID for the US centres of this multi-centre trial. This registration is for the associated NZ-based study. The research protocol and treatment protocols are the same in the NZ study as in the US centres of this multi-centre trial.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
40 years of age or older Meet the American College of Rheumatology (ACR) clinical criteria for a diagnosis of knee OA. The ACR clinical criteria for knee OA includes knee pain plus 3 of the following 6 criteria: age > 50 years, morning stiffness of < 30 minutes, crepitus on active movement, tenderness of the bony margins of the joint, bony enlargement of the joint noted on exam, lack of palpable warmth of the synovium. Based on this criteria, a subject who is less than 50 years but has knee pain and 3 of the other 5 criteria would also be classified as having knee OA.
Exclusion criteria
do not meet the ACR clinical criteria for knee OA, are scheduled for total knee arthroplasty (TKA) surgery, have undergone TJA surgery on any lower extremity joint, exhibit uncontrolled hypertension (i.e. individuals not currently taking medication for hypertension whose systolic blood pressure is greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg at rest), have complaints of low back pain or other lower extremity joint pain that affects function at the time of recruitment, have a history of neurological disorders that would affect lower extremity function (stroke, peripheral neuropathy, parkinson's disease, multiple sclerosis, etc.), are women who are pregnant.
Outcome results
None listed