Effect of laser acupuncture on adhesive small bowel obstruction: A prospective double-blind randomized controlled trial

Adhesive small bowel obstruction (ASBO) represents one of the most frequent complications after abdominal surgeries, accounting for an incidence rate of 2.4% across all types of abdominal procedures. This condition results primarily from the formation of postsurgical adhesions, although it may also arise from inflammatory processes, intraperitoneal infections, or abdominal trauma. Initial management of ASBO traditionally consists of conservative treatment in the first 72 hours, including fasting and decompression with a nasogastric tube, with approximately 70% to 90% of patients responding adequately to this nonoperative approach. However, when conservative treatment fails after three days, surgical intervention becomes necessary and is associated with higher rates of mortality and complications.

This research protocol proposes an innovative approach through a prospective, double-blind, randomized controlled trial to investigate the efficacy of laser acupuncture as adjunctive treatment in ASBO. Laser acupuncture combines principles of traditional acupuncture with low-level laser therapy, offering a noninvasive modality that has demonstrated potential to inhibit the formation of intra-abdominal adhesions in preclinical studies. The study will be conducted at Kaohsiung Chang Gung Memorial Hospital, Taiwan, enrolling 92 participants diagnosed with ASBO, randomized in a 1:1 ratio to receive either active or sham laser acupuncture, both combined with conventional treatment. The intervention consists of daily application of laser acupuncture for six consecutive days at six specific acupoints: LI-4 (Hegu), PC-6 (Neiguan), ST-25 (Tianshu), ST-36 (Zusanli), CV-4 (Guanyuan), and CV-12 (Zhongwan).

These points were selected based on traditional Chinese medicine principles to stimulate gastrointestinal motility and reduce inflammation. The equipment used will be a gallium aluminum arsenide laser with a maximum power of 150 mW, a wavelength of 810 nm, applying 0.375 J of energy at each point for five seconds. The primary endpoint will be the success rate of conservative treatment, defined as no need for nasogastric tube decompression or surgical intervention. Secondary endpoints include time to resumption of oral diet, length of hospital stay, and changes in serum levels of specific biomarkers: lipase, amylase, cortisol, motilin, ghrelin, and intestinal fatty acid-binding protein (I-FABP).

These biomarkers were chosen for their relationship with intestinal motility, inflammatory response, and intestinal wall integrity. The double-blind design ensures that both participants and assessors remain blinded to treatment allocation, using identical-appearing devices that differ only in laser energy emission. Randomization will be performed by an independent researcher using computer-generated numbers. The sample size calculation was based on a previous study with sesame oil for ASBO, considering 95% statistical power, 5% significance, and a 10% dropout rate.

Statistical analysis will employ chi-square test or t-test for between-group comparisons, considering statistical significance at p < 0.05. This pioneering study has significant clinical relevance by investigating a noninvasive therapeutic modality that could potentially increase the success rates of conservative treatment, reduce the need for surgical intervention, and decrease length of hospital stay in patients with ASBO. The incorporation of serum biomarkers offers an objective approach for evaluating therapeutic response and understanding the mechanisms of action of laser acupuncture. The results of this study may provide robust scientific evidence for a new safe and effective therapeutic option in the management of adhesive small bowel obstruction.