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Trial of Cold Gel Therapy for Soft Tissue Injuries

Am Fam Physician. 2004 May 1;69(9):2226-2228.

The application of cold in the treatment of acute soft tissue injuries is an established therapy that commonly is used in these cases. Cryotherapy was found to be more effective than heat therapy for complete and rapid recovery of ankle sprain if started within 36 hours after the injury and used for a minimum of three days. In addition, cold therapy has few complications or side effects. Prolonged application of cold at very low temperatures can cause frostbite or nerve injuries. Currently, no randomized clinical trials prove efficacy of cold therapy on soft tissue injuries. Practical applications, indications, and contraindications have not been established. A cold-producing gel has been developed for application to injured areas. Airaksinen and associates evaluated the efficacy and safety of a cold gel in the treatment of acute soft tissue injuries.

The trial design was a prospective, randomized, double-blinded, controlled study of patients who had sports-related soft tissue injuries of the ankle, leg, knee, or hand. Patients who met the inclusion criteria were assigned to receive active cold gel or a placebo gel. Only minor soft tissue injuries were included in the study, and the injury must have occurred within 48 hours of examination. Both gels were applied to the injured area four times per day for 14 days. Participants were evaluated before entering the study and at days 7, 14, and 28 of the study period. The evaluation included a clinical assessment of the injury and patient use of a visual analog scale to report their pain. In addition, non-steroidal anti-inflammatory drugs were used as rescue medications, and their use was recorded during the study.

On a pain scale of zero to 100, the pain scores of patients who received the active cold gel decreased from 59 to 30 at day 7, to 14 by day 14, and to 7 by the end of the study. This decrease was significantly different than the decrease in pain experienced by those who received the placebo gel. Patients treated with the cold gel had a significant decrease in functional disability during the study when compared with the placebo group. Both the patients’ and the investigators’ global assessment of the treatment at the end of the study were significantly better for the cold gel versus placebo. Minor skin abrasions were reported in both the cold and placebo gel groups, but no other adverse events were reported. None of the participants discontinued the study because of adverse events.

The authors conclude that cold gel is a safe and effective treatment for sports-related soft tissue injuries. The cold gel treatment provides faster pain relief and significantly faster rehabilitation results after soft tissue injuries. Minimal side effects are related to this therapy.

Airaksinen OV, et al. Efficacy of cold gel for soft tissue injuries. A prospective randomized double-blinded trial. Am J Sports Med. September 2003;31:680–4.


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