Is Botox Effective in Relieving Pain From Knee Osteoarthritis?

NCT00279903 | Completed Phase 1 DMC

• 1 other identifier: 1565-05
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with painful knee osteoarthritis will be randomly allocated to one of three groups. Each group will receive a knee injection of: 1) cortisone, 2) low dose Botox, or 3) high dose Botox. Patients will then be followed for 6 months to see if they have significant pain relief or improvement in their activity level after the injection.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Decrease in pain at 8 weeks post injection

Secondary Outcomes (3)

• Improvement in function at 2, 4, 8, 12, 26 weeks

• Improvement in quality of life at 2, 4, 8, 12, 26 weeks

• Decrease in pain at 2, 4, 12, 26 weeks

Study Arms (3)

Cortisone

ACTIVE COMPARATOR

Drug: Cortisone

Low Dose Btx-A

EXPERIMENTAL

Drug: Botulinum toxin type A (Btx-A)

High Dose Btx-A

EXPERIMENTAL

Drug: Botulinum toxin type A (Btx-A)

Interventions

Botulinum toxin type A (Btx-A) DRUG

Participants randomized to Btx-A will be given either a low dose of 100 units or a high dose of 200 units. The Btx-A dose (100U or 200U) will be resonstituted with 4 cc of sterile non-preserved 0.9% sodium chloride solution.

Also known as: Botox

High Dose Btx-A; Low Dose Btx-A

Cortisone DRUG

1 cc of 40 mg/cc methylprednisolone will be drawn up in 22 gauge needles with 3 cc of sterile non-preserved 0.9% sodium chloride solution.

Also known as: Medrol

Cortisone

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A history of knee joint pain for greater than 6 months.
• Medial or lateral tibiofemoral joint line tenderness.
• Unilateral knee pain 6/10 or greater, on average, on the visual analog scale (VAS), that interferes with function most days per week.
• Prior failed treatment with acetaminophen and/or non steroidal anti-inflammatory medications, and physical therapy (quadriceps strengthening).
• Kellgren grade II or III radiographic changes of osteoarthritis.

You may not qualify if:

• Age less than 40 years.
• Anticoagulation with warfarin or heparin.
• Known allergy or sensitivity to any of the components of the study medications.
• Body mass index greater than 35.
• Previous major reconstructive surgery on the affected knee.
• Previous arthroscopic surgery on the affected knee in the past 12 months.
• History of crystal induced arthropathy.
• Use of aminoglycoside antibiotics, curare-like agents, or history of neuromuscular disease such as myasthenia gravis, amyotrophic lateral sclerosis, or myopathy.
• History of or evidence of active rheumatologic disease, diabetes, severe peripheral neuropathy, clinically evident cardiac or respiratory disease that interferes with functional status, or other serious diseases, including psychiatric disorders.
• Evidence of recent alcohol or drug abuse, or history of medication misuse or addiction.
• Females who are pregnant, breastfeeding, or planning a pregnancy during the study, or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
• Intra-articular (knee) or systemic steroids in the past 6 months, or intra-articular knee hyaluronic acid injection in the past 6 months.
• Patients who rate their average daily pain as less than 6 on a 10 point VAS scale at the screening visit.
• Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Botulinum Toxins, Type A; Cortisone; Methylprednisolone

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Prednisolone; Pregnadienetriols; Pregnadienes

Study Officials

• Andrea J. Boon, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 18, 2006
• First Posted: January 20, 2006
• Study Start: November 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: November 7, 2012

Record last verified: 2012-11

Locations

US (1)