Imaging Pain Relief in Osteoarthritis (IPRO)
Osteoarthritis, Chronic Pain
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Chronic Pain, Pain relief
Eligibility Criteria
Inclusion Criteria:
- Radiographically defined OA knee changes with knee pain
- Must have self-reported knee pain
- Able to give informed consent
- Over 35 years old
- Male or female
- Females not pregnant or lactating and using effective contraception
Exclusion Criteria:
People with any known contraindication to MRI like
- Intraocular metallic foreign bodies;
- Intracranial aneurysm clips;
- Cardiac pacemakers and defibrillators;
- Cochlear implants;
- People with a significant head tremor;
- People with potential metal foreign bodies due to previous accidents;
- Breastfeeding or pregnancy, confirmed by pregnancy test;
- People that are felt to be unfit for the MRI scan according to the judgement of medically qualified personnel, either on the research team, or the patient's clinical team. (eg. due to back pain, claustrophobia, acute sickness etc.) This includes patients with signs of impaired temperature regulation such as an extremely high fever;
- Patients with large tattoos, specifically in the head, neck or shoulder region;
- Persons that do not have the capacity to consent;
- Aged less than 35;
- Major medical, neurological and psychiatric co-morbidities;
- Other significant medical condition;
- Metallic agents embedded within the body (ie. Shrapnel, surgical pins);
- Refusal by participant to general practitioner (GP) being informed;
- Have uncontrolled narrow-angle glaucoma;
- Have recently taken monoamine oxidase inhibitor (MAOI) or Mellaril® (thioridazine);
- Taking fluvoxamine, ciprofloxacin or enoxacin;
- Taking St. John's Wort, a herbal treatment (Hypericum perforatum);
- Taking other medicines containing duloxetine;
- Have liver disease or severe kidney disease;
- Currently on antidepressant treatment, including treatment for pain with tricyclic agents such as amitryptiline;
- Have recently taken monoamine oxidase inhibitor (MAOI) or Mellaril® (thioridazine);
- Taking tramadol;
- Known hypersensitivity, allergy or intolerance to one of duloxetine's components;
- Unwillingness to take caution in relation to use of other centrally active substances such as alcohol and sedative drugs;
- Current treatment with potent inhibitors of CYP1A2 like fluvoxamine;
Participants undergoing acute treatment (remifentanil or placebo) have, in addition to the stated above, the following exclusion criteria:
- Taking morphine
- Known hypersensitivity, allergy or intolerance to one of remifentanil's components or other fentanyl - analogues
- Current treatment with cardiac depressant drugs such as beta-blockers and calcium channel blocking agents
Sites / Locations
- University of Nottingham - School of Medicine - Radiological Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Duloxetine
Placebo (for Duloxetine)
Remifentanil
Placebo (for Remifentanil)
Duloxetine 30 mg a day (2 weeks), then 60 mg a day (4weeks), taken by mouth
Sugar pill: 1 capsule a day (2 weeks), then 2 capsules a day (4 weeks) taken by mouth
Intravenous infusion with maximum estimated plasma target of 1.0 ng/ml, during less than 20 minutes
Intravenous infusion of normal saline, during less than 20 min