Adjunctive Wet Cupping for Acute Non-Specific Low Back Pain

Overview

This prospective randomized controlled trial evaluated the effectiveness and safety of adjunctive wet cupping therapy combined with standard pharmacological treatment in adults presenting to the emergency department with acute non-specific low back pain. A total of 80 adult patients were randomly assigned to receive either wet cupping therapy plus intravenous dexketoprofen or intravenous dexketoprofen alone. Pain intensity was assessed using the Visual Analogue Scale (VAS) at baseline and at 10, 20, and 30 minutes after treatment, as well as at 24 hours. Secondary outcomes included the need for rescue analgesia, analgesic consumption during the first 24 hours after discharge, patient satisfaction, and treatment-related adverse events. The study was designed to determine whether adding wet cupping therapy to standard pharmacological treatment provides additional pain relief and improves short-term clinical outcomes in patients with acute non-specific low back pain.

This prospective, single-center, parallel-group, randomized controlled superiority trial was conducted in the Emergency Department of a tertiary-care university hospital between March and June 2022. The study was designed to evaluate whether adjunctive wet cupping therapy provides additional short-term analgesic benefit when Adult patients aged 18 to 70 years presenting to the emergency department with acute non-specific low back pain were screened for eligibility. Patients were eligible if they voluntarily agreed to participate and had a baseline pain intensity of at least 4 on the Visual Analogue Scale (VAS). Patients were excluded if their low back pain was related to trauma, chronic low back pain, or a specific underlying pathological condition. Additional exclusion criteria included skin infection at the intended wet cupping site, pregnancy or breastfeeding, known bleeding disorders, use of anticoagulant or antithrombotic medications, clinically significant anemia or hematological disease, abnormal coagulation parameters or platelet counts, allergy to the study medication, hemodynamic instability, or inability to provide A total of 80 participants were planned for enrolment and were randomly allocated in a 1:1 ratio to either the intervention group or the control group. The intervention group received a single session of wet cupping therapy in addition to standard pharmacological treatment, while the control group received standard pharmacological treatment alone. All participants received 50 mg intravenous dexketoprofen trometamol diluted in 100 mL normal saline and administered over approximately 5 minutes immediately after enrolment. Participants whose pain remained clinically significant, defined as a VAS score greater than 4 at 30 minutes after treatment, received rescue analgesia with intravenous fentanyl at a dose of 1 mcg/kg diluted in 100 mL isotonic saline and administered over approximately 5 minutes. Wet cupping therapy was performed concurrently with standard pharmacological treatment by trained healthcare personnel under sterile conditions. The intended treatment sites were three predefined anatomical locations: one point in the posterior cervicothoracic region corresponding to the DU14 acupuncture point and two bilateral paraspinal points corresponding to the BL25 region. The patient was positioned upright and the treatment sites were disinfected with 10% povidone-iodine solution. Dry cupping was initially applied for approximately 4-5 minutes using No. 7 cups to create negative pressure. Following removal of the cups, superficial skin incisions approximately 1 mm in depth and 1-3 mm in length were made u The primary outcome was pain intensity measured using a 10-cm Visual Analogue Scale, with 0 representing no pain and 10 representing the worst imaginable pain. Pain intensity was assessed before treatment and at 10, 20, and 30 minutes after completion of the intervention, as well as at 24 hours after treatment. Secondary outcomes included the requirement for rescue analgesia within the first 30 minutes after treatment, total analgesic consumption during the first 24 hours after discharge, patient satisfaction, and Baseline demographic and clinical variables recorded at enrolment included age, sex, systolic and diastolic blood pressure, heart rate, respiratory rate, body temperature, peripheral oxygen saturation, and baseline VAS pain intensity. Rescue analgesic administration and adverse events were prospectively documented thr The sample size was calculated a priori using G\*Power software version 3.1 based on the primary outcome of the difference in VAS pain intensity between the treatment groups. Assuming a standardized effect size of 0.80, a two-sided alpha level of 0.05, and 95% statistical power, a minimum of 35 participants per group was required. The target sample size was increased to 40 participants per group to allow for potential loss to follow-up and incomplete outcome data, resulting in a planned total enrolment of 80 participants. The study protocol was reviewed and approved by the Institutional Ethics Committee (Approval No. 8/11; Approval Date: 01 March 2022). The study was conducted in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice guidelines.