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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TI of the knee | Active Comparator |
| |
| Intra-articular CSI | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-articular CSI | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC pain (WP)score | Weeks 0 | |
| Visual Analogue Scale | Weeks 0 | |
| WOMAC pain (WP)score | Weeks 2 | |
| WOMAC pain (WP)score | Weeks 4 | |
| WOMAC pain (WP)score | Weeks 12 | |
| WOMAC pain (WP)score | Weeks 26 | |
| Visual Analogue Scale | Weeks 2 | |
| Visual Analogue Scale | Weeks 4 | |
| Visual Analogue Scale | Weeks 12 | |
| Visual Analogue Scale | Weeks 26 |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC physical function score (WF) | Weeks 0,2,4,12,26 | |
| Overall assessment of the impact of the procedure by the patient (five point scale) (PA) | Weeks 0,2,4,12,26 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nigel K Arden | MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton, UK | Principal Investigator |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D061888 | Craniospinal Irradiation |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| TI of the knee | Procedure | 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. |
|
| Overall assessment of the impact of the procedure by the blinded clinician (five point scale)(CA) |
| Weeks 0,2,4,12,26 |
| Time to walk fifty metre | Weeks 0,2,4,12,26 |
| Analgesic intake | Weeks 0,2,4,12,26 |
| Side effects of the procedure | Weeks 0,2,4,12,26 |
| D012216 |
| Rheumatic Diseases |