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

NCT05310214 | Unknown DMC

• 1 other identifier: GA-2022
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Low Back Pain

Keywords

Acupuncture; laser therapy; low back pain; acupuncture points

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  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.

  3 months

• Functional disability

  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.

  3 months

Secondary Outcomes (3)

• Pain Catastrophizing

  3 months

• Functional independence.

  3 months

• Mobility of spine and pelvis

  3 months

Study Arms (2)

Acupuncture treatment (ACP)

EXPERIMENTAL

The experimental group will be treated with acupuncture

Other: Acupuncture

Laser acupuncture treatment (LACP)

ACTIVE COMPARATOR

The active comparator group will be treated with laser acupuncture

Other: Laser acupuncture

Interventions

Acupuncture 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.

Acupuncture treatment (ACP)

Laser acupuncture 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".

Laser acupuncture treatment (LACP)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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);

Sponsors & Collaborators

• University of Nove de Julho: lead

MeSH Terms

Conditions

Low Back Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomised clinical trial

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 4, 2022
• Study Start: April 1, 2022
• Primary Completion: June 10, 2022
• Study Completion: September 30, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-03