Sport injuries

Besides the mentioned bibliographic evidence of efficacy of topically administered diclofenac preparations a clinical study with Diclofenac sodium 4% Spray Gel (DicloFlex®) has been conducted. Since this disorders most often associated with swelling and pain (Nicholl et al. 1995, Ogilivie-Harris et al. 1995) the study was conducted as follows:

Objective:

Goal of the study was to proof efficacy and safety of Diclofenac sodium 4% Spray Gel (DicloFlex®) in the treatment of patients suffering from musculoskeletal disorders such as sprain, strain, contusion caused by blunt traumatisation of the joints and/or muscles, mostly by accident or in sports (14).

Methodology

The study was designed as placebo-controlled randomized multicentre trial in 236 male and female out-patients with one-sided uncomplicated ankle distortions. Traumatisation had to be occurred 2-18 hours before admission. The presence of a swelling, i.e. the difference in circumference between affected and unaffected ankle, of at least 12 mm was necessary for inclusion of the patient. Assessments were made using a 4-stage ordinal scale, or for spontaneous pain also a 100 mm visual analogue scale (VAS). Local tolerability of the treatment was recorded on a 5-stage ordinal scale. Patients were instructed to apply the Diclofenac sodium 4% Spray Gel (DicloFlex®) three times daily in regular intervals of 7-8 hours spraying 4-5 puffs to cover the affected region completely. This dosage regimen corresponds to a daily dose of 96-120 mg diclofenac. Treatment period was 14 days. Additional treatment was not allowed, except rescue medication paracatemol 500 mg tablets if required. 4 control visits were made on day 3/4, 7/8, 10/11, and 14±1. Clinical symptoms and local tolerability were assessed and any adverse event was observed. Study completion was reached at the end of the treatment period or prematurely if healing occurred. Healing was defined as nearly complete remission of the symptoms (swelling ≤3mm and sum score of clinical symptoms ≤1). Global efficacy and global tolerability were assessed finally by the investigator and by the patient on a 4 stage ordinal scale (Table 1 and Table 2).

Results

236 patients were randomised into the two treatment groups. Due to unexplained difficulties to allocate the data of 40 patients of one of the centres to real existing patients, this centre was excluded from the efficacy analysis forming the “Violation-with-Protocol Set” (20 patients each on verum and placebo treatment). Therefore, the efficacy analysis was performed with 191 patients (97 patients received verum, and 94 received placebo).

Swelling

At day 3 Diclofenac sodium 4% Spray Gel (DicloFlex®) had reduced swelling, spontaneous pain and pain during movement significantly more compared to placebo. According to investigator’s and patients' ratings, Diclofenac sodium 4% Spray Gel (DicloFlex®) proved to be significantly better than placebo and is well tolerated (Table 1 and Table 2).
Spontaneous pain, pain on active movement, tenderness, impairment of passive joint movability
The detailed study results regarding the secondary end point “Spontaneous pain” and “Pain on active movement” The levels of pain at entry are in the range of 27 to 61 mm on the VAS scale. Independent of initial pain level the patients under verum experienced a pain relief, which was significantly better than the placebo group.
Statistically significant superiority of verum to placebo could be shown for the secondary target criterions spontaneous pain and pain on active movement as well. No statistically significant difference was found for tenderness and impairment of passive joint movability.

 

Table 1: Investigators rating of global efficacy:

 

Table 2: Patients rating of global efficacy: