Duloxetine Combined With Intra-articular Injection of Corticosteroid and Hyaluronic Acid Reduces Pain in the Treatment of Knee Osteoarthritis Patients

NCT04117893 | Completed Phase 4 DMC

• 1 other identifier: KY 2019-086-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Intra-articular injection of corticosteroid and hyaluronic acid is a common treatment for osteoarthritis of the knee. As a treatment drug for patients with depression, duloxetine has been shown in many studies to effectively relieve the pain of osteoarthritis and improve the function of the knee joint. However, there is no evidence regarding the efficacy of Intra-articular injection of corticosteroid and hyaluronic acid combined with duloxetine for pain management in patients with knee osteoarthritis. The aim of the study was to test the hypothesis that Intra-articular injection of corticosteroid plus hyaluronic acid combined with duloxetine could achieve superior pain management effects to Intra-articular injection of corticosteroid plus hyaluronic acid alone in patients undergoing knee osteoarthritis pain.

Conditions

Osteoarthritis, Knee; Chronic Pain

Keywords

Osteoarthritis, Knee; Chronic Pain; hyaluronic acid; corticosteroid; duloxetine; Intra-articular injection

Outcome Measures

Primary Outcomes (1)

• Weekly mean of the 24h average pain scores

  Weekly mean of the 24h average pain scores in participants with osteoarthritis knee pain at the end of 24 weeks as reported in participants' diaries based on the 11-point Likert scale (an ordinal scale with 0 indicating 'no pain', and 10 indicating 'worst pain imaginable')

  Twenty-fourth weeks

Secondary Outcomes (5)

• The response to treatment

  At weeks 1, 2, 4, 8, 16 and 24 post-injection

• The Brief Pain Inventory

  At weeks 1, 2, 4, 8, 16 and 24 post-injection

• The Western Ontario and McMaster Universities Osteoarthritis Index

  At weeks 1, 2, 4, 8, 16 and 24 post-injection

• The Patient Global Impression of Improvement Scale

  At weeks 2, 4, 8, 16 and 24 post-injection

• Hospital Anxiety and Depression Scale

  At weeks 2, 4, 8, 16 and 24 post-injection

Study Arms (2)

Duloxetine combined with intra-articular injection

EXPERIMENTAL

Drug: Duloxetine; Drug: intra-articular injection of corticosteroid and hyaluronic acid

Intra-articular injection

ACTIVE COMPARATOR

Drug: intra-articular injection of corticosteroid and hyaluronic acid

Interventions

Duloxetine DRUG

Participants will start on duloxetine 30 mg per day for one week and then titrated up to duloxetine 60mg per day for 23 weeks.

Duloxetine combined with intra-articular injection

intra-articular injection of corticosteroid and hyaluronic acid DRUG

Participants will receive a 3.5 ml intra-articular injection of 30mg of hyaluronic acid plus 10mg of triamcinolone acetonide.

Duloxetine combined with intra-articular injection; Intra-articular injection

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants meet American College of Rheumatology clinical and radiographic criteria for the diagnosis of knee osteoarthritis with knee pain \[ pain for ≥14 days of each month for ≥3 months before study entry, with a mean score ≥4 on the 24-h average pain score (0-10) using the average of daily ratings before the trial\]
• Body mass index \< 40 kg/m2
• Radiographic criteria included Kellgren-Lawrence grade Ⅱ-III
• Knee stability, no deformity, no lumbar spondylosis with radiculopathy.
• Good cognition, and the ability to understand the study protocol and the agreement to participate.

You may not qualify if:

• Inflammatory arthritis, autoimmune disorder, septic arthritis, or any other concomitant disease (such as liver and kidney disease)
• Those who prior synovial fluid analysis indicative of a diagnosis other than osteoarthritis
• Participants with contraindications to duloxetine (currently using monoamine oxidase inhibitors, poorly controlled angle-closure glaucoma), previous exposure to duloxetine, combined with other drugs acting on the central nervous system (such as benzodiazepines) and allergic to any of the medications used in this study.
• With metabolic diseases or anticoagulation therapy
• Participants who had received invasive treatments to the knee during the past 6 months; joint replacement of the knee at any time or current infection in the affected limb.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (1)

• Li DY, Han R, Zhao ZG, Luo F. Duloxetine combined with intra-articular injection versus intra-articular injection alone for pain relief in knee osteoarthritis: a study protocol for a randomised controlled trial. BMJ Open. 2020 Oct 27;10(10):e036447. doi: 10.1136/bmjopen-2019-036447.

  PMID: 33109641 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain

Interventions

Duloxetine Hydrochloride; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Fang Luo, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a prospective, randomized, open-label blind endpoint (PROBE) study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Pain Management

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 7, 2019
• Study Start: October 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: December 31, 2021
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The date will be shared from 6 months to 5 years following article publication.
• Access Criteria: An independent review committee will be responsible for reviewing applications and purposes from investigators. The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request once the study has been completed.

Locations

CN (1)