Previous studies have indicated that patient expectations, beliefs and preferences may have an impact on treatment outcomes. The KIVIS study was primarily designed to compare two effective treatments for knee osteoarthritis (tidal irrigation (medical washout of the knee) or intra-articular corticosteroid injection). At study entry any preference expressed by the patient for each of the treatment interventions was recorded. This study assessed the effects of two treatments given at a single time-point and hence the effects of patient preference could be assessed independently of any compliance issues.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
After full aseptic preparation, 40 mg triamcinolone acetonide and 2 ml 1% lignocaine were injected into the joint cavity using the medial patello-femoral approach via a 21-gauge needle.
This was done as a day case procedure under local anaesthetic. The medial patello-femoral approach was used. After full aseptic preparation, the skin and soft tissues were infiltrated with 5e10 ml of 1% lignocaine. The joint was then instilled with a further 10 ml of 1% lignocaine. After an initial puncture using a scalpel, a 3.2 mm diameter wrist arthroscope was advanced into the joint cavity. Up to 1 l of 0.9% normal saline was then irrigated through the joint: saline was run into the joint until fully distended and then allowed to flow out of the joint in a cyclical method until the aspirated fluid runs clear for at least three successive cycles.
WOMAC pain (WP)score
Time frame: Weeks 0
Visual Analogue Scale
Time frame: Weeks 0
WOMAC pain (WP)score
Time frame: Weeks 2
WOMAC pain (WP)score
Time frame: Weeks 4
WOMAC pain (WP)score
Time frame: Weeks 12
WOMAC pain (WP)score
Time frame: Weeks 26
Visual Analogue Scale
Time frame: Weeks 2
Visual Analogue Scale
Time frame: Weeks 4
Visual Analogue Scale
Time frame: Weeks 12
Visual Analogue Scale
Time frame: Weeks 26
WOMAC physical function score (WF)
Time frame: Weeks 0,2,4,12,26
Overall assessment of the impact of the procedure by the patient (five point scale) (PA)
Time frame: Weeks 0,2,4,12,26
Overall assessment of the impact of the procedure by the blinded clinician (five point scale)(CA)
Time frame: Weeks 0,2,4,12,26
Time to walk fifty metre
Time frame: Weeks 0,2,4,12,26
Analgesic intake
Time frame: Weeks 0,2,4,12,26
Side effects of the procedure
Time frame: Weeks 0,2,4,12,26
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