Table 1.

Calculation of the CCI. Calculation was based on changes of the first 4 variables from baseline. Physician’s clinical assessments ranged from 0 (none) to 3 (severe). The last 2 variables were evaluated at each timepoint. The total CCI ranged from 0 (no effect or deterioration) to 10 (maximal effect). Successful therapy is defined as a CCI of 5 or higher.

VariableScaleCalculation per Visit
1. VAS of pain0 cm (no pain) – 10 cm (maximal pain)Improvement:

  • < 3 cm: 0

  • 3–5 cm: 1

  • > 5 cm: 2

2. Functional disability of the treated joint4-point scale of disability:

  • 0 none

  • 1 slight

  • 2 moderate

  • 3 severe

Improvement:

  • None: 0

  • 1 point: 1

  • 2 or 3 points: 2

3. Joint tenderness4-point scale:

  • 0 no tenderness

  • 1 pain on pressure

  • 2 pain and wincing on pressure

  • 3 wincing and withdrawing on pressure

Improvement:

  • None: 0

  • 1 point: 1

  • 2 or 3 points: 2

4. Joint swelling4-point scale of swelling:

  • 0 none

  • 1 slight

  • 2 moderate

  • 3 severe

Improvement:

  • None: 0

  • 1 point: 1

  • 2 or 3 points: 2

5. PtGA of the effect of therapy4-point scale of satisfaction:

  • 0 none

  • 1 little

  • 2 moderate

  • 3 considerable

Dissatisfaction or little satisfaction: 0
Moderate or considerable satisfaction: 1
6. PGA of the effect of therapy4-point scale of satisfaction:

  • 0 none

  • 1 little

  • 2 moderate

  • 3 considerable

Dissatisfaction or little satisfaction: 0
Moderate or considerable satisfaction: 1

  • CCI: composite change index; VAS: visual analog scale; PtGA: patient’s global assessment; PGA: physician’s global assessment.