Effects of Adding Photobiomodulation to a Specific Therapeutic Exercise Program for the Treatment of Individuals With Chronic Nonspecific Neck Pain.

NCT ID: NCT05400473

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-30
• Study Completion Date: 2025-03-15

Brief Summary

In the current clinical and scientific reality, conservative treatment is the most coherent clinical management with a view to the proper rehabilitation of patients with chronic neck pain, with a trend towards the use of therapeutic exercise. However, some uncertainty about the effectiveness of therapeutic exercises still remains, requiring further studies with high methodological rigor, especially with regard to multimodal treatment, such as the combination of therapeutic exercises with photobiomodulation. Thus, the objective of this project is to evaluate the effects of adding photobiomodulation to a program of specific therapeutic exercises for the treatment of individuals with chronic non-specific neck pain. For this, 60 participants will be randomized into two groups: therapeutic exercise group + photobiomodulation (n = 30), and therapeutic exercise group (n = 30). There will be 10 treatment sessions and participants will be evaluated before, after the 10 sessions, and 4 weeks after the end of treatment using the Numerical Pain Scale, Neck Disability Index, Catastrophic Thoughts about Pain Scale, and Tampa Kinesiophobia Scale. In the statistical analysis, a linear mixed model will be applied, considering the interaction between the time and group factors. Finally, the addition of photobiomodulation to a therapeutic exercise program is expected to generate clinical improvements for patients with chronic neck pain.

Conditions

Neck Pain; Chronic Pain

Study Design

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

Study Groups

Therapeutic exercise group

1.Movements of flexion, extension, inclinations, and rotations of the cervical region at maximum amplitude and without load. 2.Neural mobilization of the cervical nerve roots. 3.Contraction of the deep muscles of the flexors, extensors, and rotators of the cervical region without performing spinal movements, using the movement of the eyes to aid in the accomplishment of these exercises. 4.Isometric contraction of the flexor muscles, inclinators, and rotators against manual resistance of the physiotherapist. 5.Isometric contraction of the cervical extensors of the cervical region against gravity. 6.Contraction of the flexor muscles, extensors, and incliners of the cervical region against the resistance of elastic bands.

Group Type: ACTIVE_COMPARATOR

Therapeutic exercise

Intervention Type: OTHER

This group will consist of 30 participants. A program consisting of specific therapeutic exercises for the cervical region will be applied.

Therapeutic exercise group + photobiomodulation

This group will consist of 30 participants. Initially, photobiomodulation will be applied on the cervical region. A low-power infrared laser therapy unit (Therapy XT - ANVISA RDC Standard 185/2001 - DMC, São Paulo, SP, Brazil) will be used to carry out the photobiomodulation protocol. The infrared laser therapy unit to be used has the characteristics: continuous optical output of 100 mW, with a wavelength of 808 nm, beam size area of 0.028 cm2, power density 1.78 W/cm2, with 7 Joules per point, with a duration of 70 seconds of application for each point.For application, the individual will be seated. With the cervical region bare, the therapist will position the tip of the laser therapy unit perpendicularly on each of the 12 predefined points along the cervical region (6 points laterally to the right and 6 points laterally to the left).

Group Type: EXPERIMENTAL

Therapeutic exercise

Intervention Type: OTHER

This group will consist of 30 participants. A program consisting of specific therapeutic exercises for the cervical region will be applied.

Photobiomodulation

Intervention Type: OTHER

Photobiomodulation will be applied on the cervical region. To perform the photobiomodulation protocol, a low power infrared laser therapy unit will be used.

Interventions

Therapeutic exercise

This group will consist of 30 participants. A program consisting of specific therapeutic exercises for the cervical region will be applied.

Intervention Type: OTHER

Photobiomodulation

Photobiomodulation will be applied on the cervical region. To perform the photobiomodulation protocol, a low power infrared laser therapy unit will be used.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• With chronic neck pain (for more than 90 days)
• Identified according to the following criteria: NDI score ≥ 5
• Numerical Pain Scale (END) score ≥ 3 at rest or during active neck movement

Exclusion Criteria

• Individuals who had a history of cervical trauma; head, face, or cervical surgery
• Degenerative diseases of the spine
• Pain radiating to the upper limbs
• Having been submitted to physiotherapeutic treatment for the cervical region in the last three months
• Use of analgesics, anti-inflammatory drugs, or muscle relaxants in the last week; the presence of systemic diseases
• Medical diagnosis of fibromyalgia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cid André Fidelis de Paula Gomes

OTHER

Sponsor Role: lead

Responsible Party

Cid André Fidelis de Paula Gomes

Phd, professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Cid Gomes, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

University of Nove de Julho

São Paulo, , Brazil

Countries

Brazil

References

Barbosa da Silva AC, Santana GN, Santos IS, Dos Santos PG, de Oliveira AR, Filho AVD, de Paula Gomes CAF. Multimodal therapeutic intervention program associated with photobiomodulation therapy for individuals with chronic nonspecific neck pain: protocol for a clinical trial. Trials. 2024 Jul 3;25(1):442. doi: 10.1186/s13063-024-08289-1.

Reference Type: DERIVED

PMID: 38961460 (View on PubMed)

Other Identifiers

58616022.1.0000.5511

Identifier Type: -

Identifier Source: org_study_id