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Efficacy of multiwavelength light therapy in the treatment of pressure ulcers in subjects with disorders of the spinal cord: a randomized double-blind controlled trial |
Taly AB, Sivaraman Nair KP, Murali T, John A |
Archives of Physical Medicine and Rehabilitation 2004 Oct;85(10):1657-1661 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To study the efficacy of multiwavelength light therapy in the treatment of pressure ulcers in subjects with spinal cord disorders. DESIGN: Randomized controlled trial. SETTING: Neurologic rehabilitation ward of a referral center in India. PARTICIPANTS: Thirty-five subjects with spinal cord injury, with 64 pressure ulcers (stage 2, n = 55; stage 3, n = 8; stage 4, n = 1), were randomized into treatment and control groups. One subject refused consent. Mean duration of ulcers in the treatment group was 34.2 +/- 45.5 days and in the control group, 57.1 +/- 43.5 days. INTERVENTIONS: Treatment group received 14 sessions of multiwavelength light therapy, with 46 probes of different wavelengths from a gallium-aluminum-arsenide laser source, 3 times a week. Energy used was 4.5 J/cm2. Ulcers in the control group received sham treatment. MAIN OUTCOME MEASURES: Healing of the ulcer, defined as the complete closure of the wound with healthy scar tissue, time taken for the ulcer to heal, and stage of the ulcer and Pressure Sore Status Tool score 14 days after last treatment. RESULTS: There was no significant difference in healing between the treatment and control groups. Eighteen ulcers in treatment group and 14 in control group healed completely (p = 0.802). Mean time taken by the ulcers to heal was 2.45 +/- 2.06 weeks in the treatment group and 1.78 +/- 2.13 weeks in the control group (p = 0.330). Time taken for stage 3 and 4 ulcers to reach stage 2 was 2.25 +/- 0.5 weeks in treatment group and 4.33 +/- 1.53 weeks in control group (p = 0.047). CONCLUSIONS: Multiwavelength light therapy from a gallium-aluminum-arsenide laser source did not influence overall healing pressure ulcers. Limited evidence suggested that it improved healing of stage 3 and 4 pressure ulcers.
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