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

NCT ID: NCT05310214

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Acupuncture treatment (ACP)

The experimental group will be treated with acupuncture

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

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.

Laser acupuncture treatment (LACP)

The active comparator group will be treated with laser acupuncture

Group Type: ACTIVE_COMPARATOR

Laser acupuncture

Intervention Type: OTHER

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".

Interventions

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.

Intervention Type: 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".

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18-65 years;
• Non-specific LBP for at least three months
• Pain intensity of at least 2 points measured using the Numeric Pain Rating Scale

Exclusion Criteria

• Pregnancy;
• Any contraindication to ACP or having undergone treatment in the previous six months
• Having undergone spinal surgery in the previous six months;
• Serious spinal pathology (e.g. metastasis, spinal fracture, inflammatory, and infective diseases, caudal equine syndrome, canal stenosis, osteoporosis, rheumatoid arthritis and lumbar radiculopathy);
• Currently in an acute inflammatory phase of known gastrointestinal or urinary diseases (such as cholecysticis, renal calculi, peritonitis, appendicitis);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Fabiano Politti

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

GA-2022

Identifier Type: -

Identifier Source: org_study_id