Prednisolone for Pain Reduction in Knee OA

NCT01619163 | Completed Phase 4 DMC

• 1 other identifier: alexmed11662452
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Osteoarthritis (OA), a common disabling condition, is the commonest type of arthritis worldwide. Knee OA is the 4th leading cause of disability in women. Pain is the leading symptom and is often chronic in nature leading to significant morbidity and decreased quality of life. Synovitis is prevalent in knee OA and treatment to relieve this synovitis may reduce pain. Objectives: A randomized double-blind placebo-controlled trial will be conducted to assess whether 6 weeks of daily low dose oral prednisolone will improve pain, mobility and systemic low-grade inflammation, in the short term and to determine if it sustained long term at 12 weeks in older adults with moderate to severe knee OA. Methods: 125 community-dwelling older adults aged 65 years and above with primary knee OA diagnosed according to the ACR criteria for diagnosis of primary OA of the knee will berandomized 1:1. Sixty three will receive 7.5 mg/day of prednisolone and 62 will receive placebo together with their usual therapy for 6 weeks. The primary outcome measure will be pain reduction. Secondary outcome measures will be reduction in systemic inflammation and improvements in physical functioning scores. Alterations in dosage of analgesic/NSAID drugs used will be recorded. Safety and tolerability were also assessed. Data will be collected at baseline, 6 weeks and at 12 weeks to determine any change in results from those obtained at 6 weeks. Exclusion criteria will include any inflammatory or serious medical condition. Knee OA will be documented by radiographic examination using the Kellgren-Lawrence scale. Symptomatic OA will be defined as the need to take NSAIDs daily and LequesneAlgofunctional Index (LFI)score \> 4. Clinical assessment will be include: Visual Analogue Pain Scale (VAS, 0-100), self-reported physical function as measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), WOMAC pain and stiffness scores, and six-minute walk distance (6MWD). All patients will undergo a physical examination and will be questioned about the number of flares, pain and analgesic use. Blood samples will be collected and serum levels of IL-1, IL-6, TNF-alpha and hsCRP will be measured in all patients.

Conditions

Pain

Keywords

Prednisolone,; pain,; inflammation,; mobility; Function

Outcome Measures

Primary Outcomes (1)

• Pain reduction

  The primary outcome measure was pain reduction.

  6 weeks

Secondary Outcomes (1)

• Reduction in systemic inflammation and improvements in physical functioning scores.

  6 weeks

Study Arms (2)

prednisolone

EXPERIMENTAL

Drug: Prednisolone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Placebo

Prednisolone DRUG

low dose, 7.5 mg/day

prednisolone

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Community-dwelling older adults aged 65 years and above with primary knee OA diagnosed according to the ACR criteria for diagnosis of primary OA of the knee

You may not qualify if:

• Any inflammatory or serious medical condition

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Faculty of Medicine, University of Alexandria

Alexandria, 00203, Egypt

Location

Related Publications (1)

• Abou-Raya A, Abou-Raya S, Khadrawi T, Helmii M. Effect of low-dose oral prednisolone on symptoms and systemic inflammation in older adults with moderate to severe knee osteoarthritis: a randomized placebo-controlled trial. J Rheumatol. 2014 Jan;41(1):53-9. doi: 10.3899/jrheum.130199. Epub 2013 Dec 1.

  PMID: 24293578 DERIVED

MeSH Terms

Conditions

Pain; Inflammation

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rheumatology

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 14, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: June 14, 2012

Record last verified: 2012-06

Locations

EG (1)