The Efficacy of Diclofenac Gel for Breakthrough Pain and the Neuropathic Components of Pain in Knee Osteoarthritis

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Knee Osteoarthritis

Treatments: Drug: Diclofenac Gel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01383954

2009p000667

Details and patient eligibility

About

The purpose of this proposed study is to conduct a trial with knee osteoarthritis (OA) patients using the diclofenac gel.

Full description

The purpose of this proposed study is to conduct a trial with knee OA patients using the diclofenac gel. The effectiveness of diclofenac gel in managing breakthrough pain or the neuropathic components of pain (e.g., the burning, soft tissue joint sensitivity, or allodynic components) in knee OA is unknown. It is likely that patients will use the gel in a as needed (prn) fashion, on top of other analgesics prescribed for their pain. The neuropathic components of a generally nociceptive or inflammatory condition, such as knee OA, are underappreciated, and typically not tracked in OA analgesic studies. Yet, evidence across a variety of chronic painful conditions suggests that these components are quite disabling. The results of this study would show whether diclofenac gel as a prn medication is beneficial to patients suffering from knee OA pain.

Enrollment: 52 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 20-75
• Unilateral or bilateral knee osteoarthritis (OA), confirmed radiographically.
• Patients taking oral non-steroidal anti-inflammatory drugs (NSAIDs) in the amount and schedule prior to the breakthrough period will be permitted.

Exclusion criteria

• Patients with clinical history of anterior cruciate ligament (ACL) involvement.
• Patients on tricyclic antidepressants or anticonvulsants (neuropathic medications)
• History of ulcers or gastrointestinal (GI) bleeding
• Coagulation disorders
• Hypersensitivity to Aspirin or NSAIDS
• Congestive Heart Failure and Edema
• Advanced renal disease
• Aspirin triad
• Pregnant women

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Diclofenac gel

Other group

Description:

Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.

Treatment:

Drug: Diclofenac Gel