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

Not Applicable

• Conditions: Low Back Pain
• Interventions: Other: Acupuncture; Other: Laser acupuncture

• Registration Number: NCT05310214
• Lead Sponsor: University of Nove de Julho

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).

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-31
• Last Update Submitted: 2022-03-31
• Study Start: 2022-04-01
• Study First Posted: 2022-04-04
• Last Update Posted: 2022-04-04
• Primary Completion: 2022-06-10
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture treatment (ACP)	Acupuncture	The experimental group will be treated with acupuncture
Laser acupuncture treatment (LACP)	Laser acupuncture	The active comparator group will be treated with laser acupuncture

Primary Outcome Measures

Name	Time	Method
Pain intensity	3 months	The Numeric Pain Rating Scale will be used to determine the level of pain intensity perceived by the patient using an 11-point scale on which 0 represents the absence of pain and 10 represents the worst pain imaginable.
Functional disability	3 months	The Oswestry Disability Index will be used to determine the functional disability of participants. Questionnaire examines perceived level of disability in 10 everyday activities of daily living. The 6 statements are scored from 0 to 5 with the first statement scoring 0 through to the last at 5. Interpretation of Scores; 1. 0% to 20% - minimal disability; 2. 21%-40% - moderate disability; 3. 41%-60%- severe disability; 4. 61%-80%- crippled; 5. 81%-100%: These patients are either bed-bound or exaggerating their symptoms.

Secondary Outcome Measures

Name	Time	Method
Pain Catastrophizing	3 months	The Pain Catastrophizing Scale will be used to assess catastrophic thinking related to pain. 13 items rated on 5-point Likert scales, from (0) not at all to (4) all the time. Higher score indicates higher level of catastrophizing; Item scores are summed into a total score (PCS-T) and three subscale scores: * Rumination: Items 8, 9, 10, and 11 (response: 0-16 points); * Magnification: Items 6, 7, 13 (response: 0-12 points); * Helplessness: Items 1, 2, 3, 4, 5, and 12 (response: 0-24points) A total score above 30 indicates clinically relevant level of catastrophizing
Mobility of spine and pelvis	3 months	The fingertip-to-floor test will be used to evaluate the mobility of both the whole spine and the pelvis in the overall motion of bending forward.; If the fingertip-to-floor test is "0"cm or the patient is able to place their palms to the floor with no pain, a different outcome measure should be considered.
Functional independence.	3 months	The Patient-Specific Functional Scale will be used to assess the participant's levels of functional independence. Patients are asked to rate (on an 11-point scale) the current level of difficulty associated with each activity. Following the intervention, patients are asked again to rate the activities previously identified (and are given the chance to nominate new problematic activities that might have arisen during that time).; "0" represents "unable to perform" and "10" represents "able to perform at prior level"