Effect of a Physiotherapy Program Combined With Photobiomodulation on Neuropathic Pain, Disability, and Quality of Life in Leprosy Patients: A Randomized Controlled Trial
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Background: Neuropathic pain is a frequent and disabling complication among people treated for leprosy and may persist after completion of multidrug therapy because established peripheral nerve injury is not fully reversed by antimicrobial treatment. Physiotherapy is central to leprosy rehabilitation, but pain relief and functional recovery may remain incomplete. Photobiomodulation has been proposed as a non-invasive adjunctive intervention for neuropathic pain through anti-inflammatory and neuromodulatory mechanisms. Objective: To evaluate whether standardized physiotherapy combined with active photobiomodulation improves neuropathic pain, disability, participation, quality of life, and functional capacity more than standardized physiotherapy with sham photobiomodulation in adults with treated leprosy. Methods: In this parallel-group randomized controlled trial, 154 adults aged 18–65 years with confirmed leprosy, completed multidrug therapy, VAS pain ≥40 mm, and DN4 score ≥4 were allocated equally to physiotherapy plus sham photobiomodulation or physiotherapy plus active photobiomodulation for 12 weeks. The primary outcome was change in VAS pain score from baseline to week 12. Secondary outcomes included SALSA score, Participation Scale score, SF-36 pain domain, and hand grip strength. Results: VAS pain decreased from 60.2 ± 11.1 mm to 27.9 ± 10.4 mm in the active photobiomodulation group and from 62.1 ± 12.3 mm to 44.8 ± 13.1 mm in the sham group, with a between-group difference of 15.0 mm (95% CI, 11.8–18.2; p < 0.001; Cohen’s d = 0.93). Clinical response occurred in 75.3% and 31.2% of participants, respectively (NNT = 2.27). Secondary outcomes also favored active photobiomodulation, including SALSA, participation, SF-36 pain, and grip strength. No serious adverse events were reported. Conclusion: Active photobiomodulation may be an effective and safe adjunct to physiotherapy for leprosy-related neuropathic pain, with clinically meaningful benefits across pain and functional outcomes. Multicenter trials with longer follow-up and verified dosimetry are warranted before broad implementation
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