L-arginine for Knee Osteoarthritis Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorXiangya Hospital of Central South University

About this trial

This study will examine the pain-relief efficacy and safety of L-arginine in knee OA patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 40 and 80 years.

Knee OA according to the American College of Rheumatology (ACR) clinical criteria.

Knee pain lasting 3 months or longer and a score of 7 or greater on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (standardized to range from 0-20).

Kellgren-Lawrence (KL) grade 2 or 3.

Disqualifiers

Any use of NSAIDs or other analgesics in the past two weeks.

History of injections of corticosteroids in the past three months or hyaluronic acid in the past 6 months in the index knee.

History of arthroscopy or open surgery in the index knee in the past 12 months.

History of a knee replacement in the index knee or planning to receive such a procedure within 3 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • L-arginine tablet

    Dietary supplement

    L-arginine, 2 g, three times daily, for 12 weeks

  • Placebo tablet

    Dietary supplement

    Identical inert placebo, three times daily, for 12 weeks

Treatment groups

340 Participants
are divided into 2 treatment groups
Group A: Oral L-arginineActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score.

WOMAC is a self-administered, disease-specific questionnaire that assesses the severity of OA symptoms. The reliability and validity of WOMAC have been confirmed in many clinical trials. WOMAC subscales consist of pain (5 items), stiffness (2 items), and physical function (17 items). Each item is rated from 0 to 4, totaling scores of 0-20, 0-8, and 0-68 for pain, stiffness, and function subscales, respectively.

Time frame
Baseline, Week 12

Secondary outcomes

1

Change From Baseline in WOMAC pain score.

WOMAC is a self-administered, disease-specific questionnaire that assesses the severity of OA symptoms. The reliability and validity of WOMAC have been confirmed in many clinical trials. WOMAC subscales consist of pain (5 items), stiffness (2 items), and physical function (17 items). Each item is rated from 0 to 4, totaling scores of 0-20, 0-8, and 0-68 for pain, stiffness, and function subscales, respectively.

Time frame
Baseline, Weeks 2, 4 and 8
2

Change From Baseline in Knee pain on a visual analogue scale (VAS).

Knee pain will be graded by a VAS from 0 to 100 mm, with 0 indicating "No pain" and 100 indicating "Worst possible pain".

Time frame
Baseline, Weeks 2, 4, 8 and 12
3

Change From Baseline in WOMAC total score.

WOMAC is a self-administered, disease-specific questionnaire that assesses the severity of OA symptoms. The reliability and validity of this index have been confirmed in many clinical trials. WOMAC subscales consist of pain (5 items), stiffness (2 items), and physical function (17 items). Each item is rated from 0 to 4, totaling scores of 0-20, 0-8, and 0-68 for pain, stiffness, and function subscales, respectively.

Time frame
Baseline, Weeks 2, 4, 8 and 12
4

Change From Baseline in Change From Baseline in WOMAC stiffness score.

WOMAC is a self-administered, disease-specific questionnaire that assesses the severity of OA symptoms. The reliability and validity of WOMAC have been confirmed in many clinical trials. WOMAC subscales consist of pain (5 items), stiffness (2 items), and physical function (17 items). Each item is rated from 0 to 4, totaling scores of 0-20, 0-8, and 0-68 for pain, stiffness, and function subscales, respectively.

Time frame
Baseline, Weeks 2, 4, 8 and 12

Other outcomes

1

Change From Baseline in Short Physical Performance Battery (SPPB) scores.

The SPPB is a standardized, reproducible measure of global physical function validated in frail older persons that predicts a wide range of clinical outcomes. It has 3 components: a standing balance test, gait speed (4-meter walk) test, and strength test (time to complete 5 chair rises). Each component is scored 0-4 for a total score ranging from 0-12, where lower scores indicate more severe physical dysfunction.

Time frame
Baseline, Weeks 4, 8 and 12
2

Change From Baseline in Grip strength.

The grip strength of the participants' dominant hand will be measured using a calibrated Jamar dynamometer with the participants in the sitting position (Patterson Medical, Ltd., Nottinghamshire, UK). Three grip strength measurements will be taken at 10 s intervals, and the maximum value of the three measurements will be used as the participant's final grip strength.

Time frame
Baseline, Weeks 4, 8 and 12
3

Change From Baseline in Bone mineral density (BMD).

A trained technician will measure the BMD of all participants. The total body BMD and multiple site-specific BMD (i.e., the lumbar spine, pelvis, trunk, femoral neck, trochanteric, and ward's triangle) will be all measured. The dual-energy X-ray absorptiometry (DXA) scan results are reported as absolute values of BMD (g/cm2). The same DXA machine will be used for all participants. All technicians will receive training to ensure the reproducibility of the BMD measures.

Time frame
Baseline, Week 12
4

Change From Baseline in DXA-based whole-body muscle mass.

Body composition assessment provides insights into the nutritional status and functional capacity. It helps understand nutrition in the developmental origins of health and disease and in monitoring therapeutic interventions. The whole body muscle mass will be measured using DXA.

Time frame
Baseline, Week 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiangya Hospital of Central South University

Lead sponsor

Massachusetts General Hospital

Collaborator

School of Medicine, University of Nottingham

Collaborator

Memorial University of Newfoundland

Collaborator