Please select the eligibility criteria that correspond to the clinical trial below.
Title: Biomechanical Therapy for Osteoarthritis of the Knee: a Randomized Controlled Trial(BIOTOK)
Brief Summary: Painful knee osteoarthritis is common and treatments, short of knee replacement, are limited. The investigators plan to test the efficacy of a novel promising device for treatment of knee osteoarthritis affecting the inner part of the knee, the most common location. There are no disease modifying treatments available and therefore there is an emphasis on conservative management techniques to benefit individuals. Many of these treatments (insoles, braces, physiotherapy etc) have been shown to have relative success in individuals but a new novel device is demonstrating better effectiveness in this patient group. APOS (All Phases of Step) therapy consists of a shoe oriented system of care that works by shifting the load across parts of the knee and retraining the lower extremity muscles. Preliminary data suggest impressive favourable reductions in knee pain and a commensurate decrease in knee loading during walking. However, APOS treatment has never been evaluated in a randomised controlled trial even though it is widely used. The investigators propose to conduct a randomised blinded controlled trial of APOS treatment among persons with painful knee osteoarthritis affecting the inside (medial or lateral) of their knees. The investigators will focus on pain outcomes and quality of life. APOS has committed to provide the shoe system and a matched sham device, that they have developed, and will also provide the technicians trained to calibrate the pertupods (balls under the sole of the foot) on the shoe without charge. The research will be undertaken in a University setting for the gait evaluations.


Options:
A: Inclusion Criteria:

* patients referred from general practitioner, chiropractor or orthopaedic surgeon
* unilateral hip pain of minimum 3 months' duration
* radiology criteria for hip OA: joint space width (JSW) \< 2.0 mm or a side difference in JSW of \> 10%
* adequate mastering of the Danish language to complete instructions and questionnaires

Exclusion Criteria:

* inflammatory joint disease
* previous hip or knee alloplastic
* secondary arthritis due to hip fracture or infection
* bilateral hip pain
* hip dysplasia with a CE angle \> 25 degrees and an AA angle \> 10 degrees
* low back pain which dominates over the hip pain
* malignant disease
* patients with paresis or paralysis after neuromuscular, cerebrovascular or polyneuropathic disease
* hip pain resulting from labral tear, bursitis and/or snapping hip syndrome
* polyarthritis
* received manual treatment for the hip within the last year
B: Inclusion Criteria:

* Knee pain on most days
* Either isolated patellofemoral osteoarthritis or mixed patellofemoral and tibiofemoral osteoarthritis, as based on x-ray

Exclusion Criteria:

* Bed- or chair-bound, usually uses an ambulation aid to walk (e.g., cane, crutch, or walker), or uses a wheelchair
* Pain emanating more from the back or hip than from the knee, as determined by screening questionnaire
* Low pain score on the visual analog scale (VAS) (less than 4 out of 10)
* Plans to move from the area within 10 months of study screening
* Symptomatic comorbid disease that limits activities more than knee pain does, as determined by screening questionnaire (e.g., congestive heart failure, chronic obstructive pulmonary disease)
* Receiving corticosteroid injections in the month before study entry, or receiving hyaluronan in the 6-month period before study entry. No other treatments will result in exclusion, although for patients taking glucosamine and/or chondroitin and/or a non-steroidal anti-inflammatory drug (NSAID), they must have taken these treatments for at least 2 months before study entry and must commit to not start a new treatment during the study.
* Bilateral total knee replacements or plans for a total knee replacement of the affected knee in the next 6 months
* Morbidly obese (body mass index greater than 35), as brace fitting and prevention of slippage of the brace will be difficult
* Known other causes of arthritis, including rheumatoid arthritis, systemic lupus erythematosus, gout, psoriatic arthritis, and pseudogout
* Skin breakdown at the site where the brace will be applied
* Failure to pass the run-in test, or the brace falls down the leg during the run-in
C: Inclusion Criteria:

* Men or non-pregnant women
* Aged \>= 40
* Outpatient setting
* ACR clinical criteria for OA of the knee
* Radiologically confirmed symptomatic uni- or bilateral OA of the knee for at least 6 months
* Radiological criteria: X-rays showing tibiofemoral knee osteoarthritis defined as at least Kellgren and Lawrence Grade 2
* At least moderate pain on the WOMAC pain scale (\>3 on a standardized scale range from a minimum of 0 to a maximum of 10)
* Must understand German
* Informed Consent documented by participant signature

Exclusion Criteria

* Pregnant women
* Aged \< 40
* History of an inflammatory rheumatic disease
* Non-knee musculoskeletal pain as or more severe than the knee pain
* Glucocorticoid injections in the knees in the previous three month
* Previous osteotomy
* Unilateral hemiprosthesis
* Unilateral total joint replacement
* Being treated for cancer
* Participation in another clinical trial
D: Inclusion Criteria:

1. \>/= age 60
2. meets accepted clinical criteria for knee OA based on the American College of Rheumatology 1986 clinical criteria guidelines.
3. Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score in the range of 7-15 (to minimize including subjects with knee OA so severe they may be better served by arthroplasty)
4. PHQ-9 scores 1-9, with at least one of the cardinal symptoms of depression (low mood or anhedonia) endorsed.
5. Modified Mini Mental State (3MS) Examination \>/= 80.
6. Has or is willing to establish care with a personal physician prior to any experimental procedures.

Exclusion Criteria:

1. Major Depressive Episode or anxiety disorder within the past 1 year
2. Currently taking an antidepressant
3. History of bipolar or schizophrenia
4. Drug or alcohol use disorder within the past 12 months
5. Receiving knee-related workers compensation or involved in knee pain-related litigation.
6. Currently taking an anti-anxiety medicine \> 4 times/week for the past 4 weeks.

Answer: C