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Double-blind study comparing the use of Voltaren Emulgel versus regular gel during ultrasonic sessions in the treatment of localized traumatic and rheumatic painful conditions |
el-Hadidi T, el-Garf A |
The Journal of International Medical Research 1991 May-Jun;19(3):219-227 |
clinical trial |
6/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
A total of 120 patients with moderate to severe pain due to localized rheumatic or traumatic conditions participated in a double-blind, randomized trial. Patients were randomly allocated to receive ultrasonic sessions three times weekly for 4 weeks, using either diclofenac in a gel base (Voltaren Emulgel) or regular gel as a coupling medium. A statistically significant (p < 0.01) improvement was achieved in both treatment groups in most of the evaluation criteria by the end of the first week. Treatment was prematurely discontinued due to complete cure in 60% of patients using Voltaren Emulgel compared with only 15% of those using regular gel (p < 0.01). Physician's assessment of complete relief of pain was also statistically significant (p < 0.01) in favour of Voltaren Emulgel throughout the trial period and the physician's overall assessment of therapeutic efficacy revealed that a satisfactory result was achieved in 86% of Voltaren Emulgel-treated patients compared with 76% of patients receiving regular gel (p < 0.05). Tolerability was good or excellent in over 95% of patients in both treatment groups. The results of the study strongly suggest that the use of Voltaren Emulgel as a coupling medium during ultrasonic therapy is a preferable, effective alternative to the currently used regular gel.
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