Laser acupuncture for claudication symptoms in peripheral artery disease - Does it work? A randomized trial.

Abstract

Background: Peripheral artery disease (PAD) receives little attention despite its clinical consequences. Intermittent claudication is the most disturbing symptom of the disease resulting in marked limitations to functional walking performance. Treadmill walking exercise is the first-line non-pharmacological treatment in PAD; however, older patients may be unable to exercise because of the functional disability of the disease itself or deconditioning.

Objective: In an attempt to seek an alternative intervention, this study aimed to assess the effect of laser acupuncture on patient-reported claudication symptoms and walk performance in PAD.

Methods: Thirty male patients with PAD were assigned randomly to a control group ( $n_1=15$ , $64.5\pm 3.5$ years old, $25.9\pm 2.6$ kg/m²) or a study group ( $n_2=15$ , $65.6\pm 3.3$ years old, $25.44\pm 3.1$ kg/m²). Inclusion criteria were mild-to-moderate PAD, Fontaine stage II, unilateral or bilateral claudications, and older men. Exclusion criteria were asymptomatic PAD, resting pain, severe or critical limb ischemia, ischemic ulcers, and patients contraindicated for laser therapy. Both groups received pharmacological treatment, but only the study group received gallium aluminum arsenide (GaAlAs) laser therapy at nine acupuncture points, namely, Liver 2 (LV2), Stomach 41 (ST41), Urinary bladder 40 (UB40), UB60, UB61, Gall bladder 30 (GB30), GB34, GB38, and GB40 for 2 days/week and five consecutive weeks. A pen-type laser device was used at a wavelength of $654.7\pm 2$ nm, with a power output of $41\pm 3.65$ mW, a spot size of 0.08 cm², and an energy density of 2 J/cm², for 60 s/point. The Edinburgh Claudication Questionnaire (ECQ) and the 6-min walk distance (6-MWD) were the endpoints of the study. The McNemar-Bowker Test and Generalized Estimating Equations Ordinal Logistic Regression Model were used for the within- and between-group statistical analyses of the categorical data of ECQ, respectively; and a mixed model MANOVA was used for the within- and between-group analyses of the 6-MWD data.

Results: There was a significant improvement in patients' response to ECQ only in the study group compared to the baseline ( $p=0.002$ ) and the controls ( $p<0.001$ ) after the intervention. The 6-MWD increased significantly in the study group compared to the baseline ( $318\pm 77$ m versus $214\pm 60$ m, $p<0.001$ ).

Conclusion: The GaAlAs laser acupuncture applied at selected acupoints may be a promising intervention complementary to drug therapy that could help relieve claudication symptoms and improve physical functional performance in older men with PAD (Fontaine stage II). Trials were conducted under the Trial Registration No. PACTR201912698539774.