Laser Therapy on Neck Pain in Adolescents

NCT01849913 | Unknown DMC

• 1 other identifier: ABCDE-12345
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the proposed study is to investigate the effects of low-level laser therapy on neck pain.

Conditions

Neck Pain

Keywords

neck pain; hydrocortisone; stress; electromyography; adolescent; low-level laser therapy

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index - NDI

  Recruitment will be determined from the results of the application of the NDI, which is composed of 10 questions addressing general activities and pain. The items are organized by the type of activity and involve six response options expressing progressive degrees of functional disability. Patients who had a score above 10% on the ndi questionnaire answers will be interviewed with the following questions: do you feel any pain often?, have had torticollis? how many times? and as to the time of pain. Those who answer that has intermittent pain for 3 months or more will be selected.

  One Year

Secondary Outcomes (8)

• Surface electromyography (EMG) of neck extensors

  baseline and 6 weeks

• Analysis of salivary cortisol

  baseline and 6 weeks

• Neck extensor endurance test

  baseline and 90 days

• Evaluation of cervical range of motion

  baseline and 90 days

• Postural evaluation

  baseline and 90 days

Study Arms (2)

Group B & Group C

EXPERIMENTAL

Group B equal to low-level laser therapy dosis 5,9 j per point Group C equal to Placebo group

Other: Laser; Other: Placebo

Group A & Group C

NO INTERVENTION

Group A equal to Control (no intervention) Group C equal to Placebo group

Interventions

Laser OTHER

The laser will be used 830 nm, 30 milliwatts twice a week: the initial dosage will be 5.9 J per point. The irradiation will be performed bilaterally on the belly of the trapezius muscle as well as 2 cm to the right and left and 2 and 4 cm below the belly of the muscle.

Group B & Group C

Placebo OTHER

To provide the "blinding": the laser equipment has two identical application points furnished by the manufacturer - one active and the other a placebo (does not emit energy).

Group B & Group C

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age 14 to 20 years;
• chronic neck pain;
• no use of corticoids for at least 15 days prior to the onset of treatment;
• agreement to participate; and
• signed statement of informed consent by legal guardian.

You may not qualify if:

• Currently undergoing physical therapy;
• inability to participate in sessions;
• specific diagnosis of infection, osteoporosis, polyarthritis or rheumatic disease; and
• constant use of corticoids or analgesics.

Sponsors & Collaborators

• University of Nove de Julho: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University of Nove de Julho

São Paulo, São Paulo, 01504-001, Brazil

RECRUITING

Related Publications (3)

• Chow RT, Johnson MI, Lopes-Martins RA, Bjordal JM. Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. Lancet. 2009 Dec 5;374(9705):1897-908. doi: 10.1016/S0140-6736(09)61522-1. Epub 2009 Nov 13.

  PMID: 19913903 RESULT

• Verhagen AP, Schellingerhout JM. Low-level laser therapy for neck pain. Lancet. 2010 Feb 27;375(9716):721; author reply 722. doi: 10.1016/S0140-6736(10)60296-6. No abstract available.

  PMID: 20189016 RESULT

• Gross AR, Aker PD, Goldsmith CH, Peloso P. Patient education for mechanical neck disorders. Cochrane Database Syst Rev. 2000;1998(2):CD000962. doi: 10.1002/14651858.CD000962.

  PMID: 10796403 RESULT

MeSH Terms

Conditions

Neck Pain

Interventions

Lasers

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Deise S Araujo

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deise S Araujo

CONTACT

5511 981150052; deise.fisio@ymail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: May 9, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: January 1, 2014
• Last Updated: May 9, 2013

Record last verified: 2013-05

Locations

BR (1)