Saline Injections vs Education and Exercise in Knee Osteoarthritis

PHASE2CompletedINTERVENTIONAL
Enrollment

206

Participants

Timeline

Start Date

August 5, 2019

Primary Completion Date

December 2, 2020

Study Completion Date

December 18, 2020

Conditions
Osteoarthritis, Knee
Interventions
BEHAVIORAL

GLA:D

The GLA:D exercise and education program is an 8-week treatment program delivered by GLA:D certified physiotherapists. It consists of 2 educational sessions over 2 weeks (1/week in week 1 and 2) and 12 exercise sessions over 6 weeks (2/week in weeks 2 thru 8) The 2 educational sessions provide knowledge of OA, treatment and self-management, with a special focus on exercise and its benefits. The exercise part lasts for 6 weeks with 2 exercise sessions per week of approximately 1 hour (12 sessions total). The exercise sessions are group based at a facility supervised by a GLA:D certified physiotherapist. The goal is the obtain muscle control and stability in situations resembling daily life and/or more strenuous activities.

DRUG

Intra-articular saline injection

"Four \[4\] dosages of 5 ml intra-articular isotonic saline (0.9% (9 mg/mL) Sodium Chloride Injection (sterile, isotonic solution of sodium chloride and sterile water for injection)) every other week from baseline (week 1, 3, 5 and 7 = 4 injections).~The injections will be carried out with a 21 gauge (38 mm) needle and a Luer-lock syringe under ultrasound guidance to ensure that the needle is inserted into the study knee joint cavity and document correct deposition of the bolus in the joint cavity.~If the investigator detects presence of excessive joint fluid during the ultrasound guided preparation of the injection, this will be aspirated before injection of the saline - if possible."

Trial Locations (1)

2000

The Parker Institute, Frederiksberg Hospital, Copenhagen

All Listed Sponsors
lead

Marius Henriksen

OTHER

NCT03843931 - Saline Injections vs Education and Exercise in Knee Osteoarthritis | Biotech Hunter | Biotech Hunter