Chronic osteoarthritis Joint Major Evidence of | Chronic osteoarthritis Vertebral column Evidence of
Item
1. clinical evidence of chronic oa by history and examination in a major joint or the spine.
boolean
C0263778 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0332120 (UMLS CUI [1,4])
C0263778 (UMLS CUI [2,1])
C0037949 (UMLS CUI [2,2])
C0332120 (UMLS CUI [2,3])
Pain level | Numeric Pain Scale
Item
1. pain level of 4/10 or greater on a scale of 0 to 10
boolean
C0518087 (UMLS CUI [1])
C1518471 (UMLS CUI [2])
Pain Duration | Pain Frequency
Item
2. pain for a duration of 3 months or longer present at least 5 out of 7 days a week
boolean
C0030193 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2,1])
C0376249 (UMLS CUI [2,2])
Osteoarthritis Moderate Joint Involved | Osteoarthritis Severe Joint Involved | Kellgren-Lawrence score
Item
3. radiographic evidence of moderate to severe oa in the involved joint based on the kellgren and lawrence scoring scale.
boolean
C0029408 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
C1314939 (UMLS CUI [1,4])
C0029408 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0022417 (UMLS CUI [2,3])
C1314939 (UMLS CUI [2,4])
C3177117 (UMLS CUI [3])
Age
Item
2. age between 30-65 at study entry
boolean
C0001779 (UMLS CUI [1])
Gender | Ethnic group All
Item
3. men of all ethnicities
boolean
C0079399 (UMLS CUI [1])
C0015031 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
Informed Consent
Item
4. ability to understand the study measures and mentally capable of giving consent to participate in the study (based on an 8th grade education level)
boolean
C0021430 (UMLS CUI [1])
opioid use Abstinence Willing | MS Contin
Item
5. willingness to refrain from taking opioids other than as dictated by the study design
boolean
C0240602 (UMLS CUI [1,1])
C3843422 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0700786 (UMLS CUI [2])
Exclusion Criteria
Item
exclusion criteria :
boolean
C0680251 (UMLS CUI [1])
Pulmonary function Impaired | Renal Insufficiency | Liver Dysfunction | cardiovascular system function Impaired | Limited endocrine or metabolic function | Comorbidity Major | Malignant Neoplasms | Chronic Obstructive Airway Disease | Liver Dysfunction Severe | Renal dysfunction Severe
Item
1. impaired pulmonary, renal, hepatic, cardiovascular or endocrine-metabolic function; major coexisting medical condition such as cancer, chronic obstructive pulmonary disease and severe hepatic and renal dysfunction
boolean
C0231921 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2])
C0086565 (UMLS CUI [3])
C0678859 (UMLS CUI [4,1])
C0221099 (UMLS CUI [4,2])
C0497559 (UMLS CUI [5])
C0009488 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
C0006826 (UMLS CUI [7])
C0024117 (UMLS CUI [8])
C0086565 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C3279454 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
Endocrine System Disease Primary | Endocrine System Disease Secondary | Diabetes Mellitus | Cushing Syndrome
Item
2. primary or secondary endocrine disease such as diabetes or cushing's syndrome
boolean
C0014130 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0014130 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0011849 (UMLS CUI [3])
C0010481 (UMLS CUI [4])
Prostatic Disease Requirement Urological Agents
Item
3. prostatic disease requiring usage of urological medications
boolean
C0033575 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C2064919 (UMLS CUI [1,3])
Sexual Dysfunction | Lack of libido | Erectile dysfunction | Erectile abnormalities
Item
4. presence of sexual dysfunction defined as lack of libido, impotence or erectile abnormalities.
boolean
C0549622 (UMLS CUI [1])
C2981158 (UMLS CUI [2])
C0242350 (UMLS CUI [3])
C4022003 (UMLS CUI [4])
Coronary Artery Disease
Item
5. current symptoms of coronary artery disease
boolean
C1956346 (UMLS CUI [1])
Rheumatoid Arthritis | Arthritis
Item
6. presence of ra, or other types of inflammatory arthritis
boolean
C0003873 (UMLS CUI [1])
C0003864 (UMLS CUI [2])
systemic steroids
Item
7. use of systemic corticosteroids in the two months before screening and study entry
boolean
C2825233 (UMLS CUI [1])
Alcohol abuse
Item
8. alcohol abuse up to a year prior to study enrollment
boolean
C0085762 (UMLS CUI [1])
Drug abuse
Item
9. usage of any recreational drugs
boolean
C0013146 (UMLS CUI [1])
Narcotic Abuse
Item
10. history of narcotic abuse at any time in the past
boolean
C0524661 (UMLS CUI [1])
Major Depressive Disorder | Beck depression inventory
Item
11. major depression whether successfully or unsuccessfully treated or diagnosed at the time of study screening based on a score of greater than or equal to 20 on the beck depression inventory
boolean
C1269683 (UMLS CUI [1])
C0451022 (UMLS CUI [2])
Hematocrit level | Anemia | Blood Coagulation Disorder
Item
12. hct less than 35; anemia or bleeding disorder
boolean
C0518014 (UMLS CUI [1])
C0002871 (UMLS CUI [2])
C0005779 (UMLS CUI [3])
Morphine allergy
Item
13. allergy to morphine
boolean
C0570528 (UMLS CUI [1])
Fibromyalgia | Tenderness | Tender Points Minimum
Item
14. current or past history of fibromyalgia as described by wolfe f et al., (1990) (a minimum of 12 out of 19 points of tenderness must be present to satisfy criteria for fibromyalgia)
boolean
C0016053 (UMLS CUI [1])
C0234233 (UMLS CUI [2])
C1704505 (UMLS CUI [3,1])
C1524031 (UMLS CUI [3,2])
Impaired cognition | Informed Consent Unable | Protocol Compliance Unable
Item
15. cognitive impairment such that the individual is unable to give informed consent, complete study data collection tools or required study visits
boolean
C0338656 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Age
Item
16. age 29 years or less due to rarity of oa in this age group
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
17. body mass index (bmi) greater than 30kg/m(2) and bmi less than 20kg/m(2)
boolean
C1305855 (UMLS CUI [1])
Anti-Inflammatory Agents, Non-Steroidal | Muscle relaxants | Opioids | MS Contin | Antiepileptic Agents | Tricyclic Antidepressive Agents | Selective Serotonin Reuptake Inhibitors | Benzodiazepines Pain control | Injection of steroid into joint | complementary and alternative therapy | Acupuncture | Chiropractic manipulation | Medicinal Herbs | Botanical | Mind-Body Medicine | Glucosamine | Chondroitin
Item
usage of nonsteroidal anti-inflammatory drugs (nsaids) will be allowed at study entry and during the conduct of the study. patients will be asked to refrain from using muscle relaxers, other opioids apart from the study drug (ms contin), aed's (anti-epileptic drugs), tcas (tricyclic antidepressants), ssris (selective serotonin reuptake inhibitors) and benzodiazepines for pain control during part ii and iii. patients will also be asked to refrain from having local joint injections with steroids or other agents. patients will be queried regarding their use of complementary and/or alternative medicine (cam) treatments (e.g. acupuncture, chiropractic manipulations, herbs and botanicals, and mind-body interventions) at the start of the study and will be counseled against beginning cam treatments during the study protocol. starting any of these treatments during the study will be considered a study violation. the only exception will be for glucosamine and/or chondroitin.
boolean
C0003211 (UMLS CUI [1])
C0358430 (UMLS CUI [2])
C0242402 (UMLS CUI [3])
C0700786 (UMLS CUI [4])
C0003299 (UMLS CUI [5])
C0003290 (UMLS CUI [6])
C0360105 (UMLS CUI [7])
C0005064 (UMLS CUI [8,1])
C1304888 (UMLS CUI [8,2])
C0394848 (UMLS CUI [9])
C1456846 (UMLS CUI [10])
C0394664 (UMLS CUI [11])
C0600577 (UMLS CUI [12])
C0025125 (UMLS CUI [13])
C1456557 (UMLS CUI [14])
C1513305 (UMLS CUI [15])
C0017718 (UMLS CUI [16])
C0008454 (UMLS CUI [17])