NCT05310214

Effect of Acupuncture and Laser Acupuncture in the Treatment of People With Chronic Nonspecific Low Back Pain.

Effect of Acupuncture and Laser Acupuncture on Pain and Functional Capacity in People With Chronic Nonspecific Low Back Pain: a Randomised Controlled, Blinded Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this randomized clinical trial will be to compare the efficacy between acupuncture and laser acupuncture on pain and disability in people with chronic nonspecific low back pain .

Detailed description

Forty-four patients with chronic cnLBP of more than three months duration will be randomly allocated to two groups: acupuncture group (ACP) (n = 22) and laser acupuncture group (LACP) (n = 22).Interventions will last one hour, and will happen twice a week for 5 weeks. The primary clinical outcomes will be pain intensity (11-point numeric pain rating scale) as measured and functional disability (Oswestry Disability Index).The secondary outcomes will be the Pain Catastrophizing Scale, Patient-Specific Functional Scale and fingertip-to-floor test. Evaluations will be performed before and after the first session, after 5 weeks of treatment, and three months after randomization (follow-up). The findings will be analyzed statistically considering a 5% significance level (p ≤ 0.05).

Conditions

• Low Back Pain

Interventions

Type	Name	Description
OTHER	Acupuncture	Treatment with ACP will be performed by inserting sterile acupuncture needles 0.25 x 13 mm into the acupoints BL23 (Shenshu), BL25 (Dachangshu), BL40 (Weizhong), BL62 (Qixue), SI3 (Houxi) and Jiaji , for the treatment of chronic non-specific low back pain. Interventions will last one hour, and will happen twice a week for 5 weeks. In order to increase the effectiveness of blinding for both groups, in this study the model was adopted: "combined simulated control". In this case, Sham acupuncture points will be used to simulate the treatment, as follows: i) Arms: 3 cm above the lateral epicondyle of the elbow, ii) Lumbar spine: Iliac crest on the same line as the greater trochanter of the femur. Thus, in the ACP group, the placebo LACP (without dosemetry) will be applied to these 4 points together with the real treatment.
OTHER	Laser acupuncture	The use of LACP (808 nm wavelength, 100 mW, energy 6 J per acp point), on acupoints BL23 (Shenshu), BL25 (Dachangshu), BL40 (Weizhong), BL62 (Qixue), SI3 (Houxi) and Jiaji will be used as a treatment for nonspecific chronic low back pain. Interventions will last one hour, and will happen twice a week for 5 weeks. Sham acupuncture points will be used to simulate the treatment, as follows: i) Arms: 3 cm above the lateral epicondyle of the elbow, ii) Lumbar spine: Iliac crest on the same line as the greater trochanter of the femur. These sham points will be inserted superficially so that the depth is sufficient to keep them fixed during the experiment, without individuals reporting the "dequi".

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-06-10
• Completion: 2022-09-30
• First posted: 2022-04-04
• Last updated: 2022-04-04