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

NCT05400473 | Completed DMC

• 1 other identifier: 58616022.1.0000.5511
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Functional disability

  The NDI will be used to verify the degree of disability due to neck pain.Each question has six potential responses ranging in severity from zero (no disability) to five (most severe disability) with a total score maximum of 50 points.

  Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.

• Numerical Pain Scale

  The Numerical rating pain scale, a simple, easily administered scale evaluates the perceived intensity of pain, using an 11-point scale from 0, representing 'no pain', to 10, which is the 'worst possible pain'.

  Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.

Secondary Outcomes (4)

• Catastrophic Thoughts about Pain Scale

  Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.

• Kinesiophobia Tampa Scale

  Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.

• The Copenhagen Neck Functional Disability Scale (CNFDS)

  Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.

• Global Perception of Change scale

  Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.

Study Arms (2)

Therapeutic exercise group

ACTIVE COMPARATOR

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.

Other: Therapeutic exercise

Therapeutic exercise group + photobiomodulation

EXPERIMENTAL

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).

Other: Therapeutic exercise; Other: Photobiomodulation

Interventions

Therapeutic exercise 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; Therapeutic exercise group + photobiomodulation

Photobiomodulation OTHER

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

Therapeutic exercise group + photobiomodulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cid André Fidelis de Paula Gomes: lead

Study Sites (1)

University of Nove de Julho

São Paulo, 01504-001, Brazil

Location

Related Publications (1)

• 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.

  PMID: 38961460 DERIVED

MeSH Terms

Conditions

Neck Pain; Chronic Pain

Interventions

Exercise Therapy; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Laser Therapy; Phototherapy

Study Officials

• Cid Gomes, Phd

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The principal investigator will not be part of any assessment or treatment process. Two researchers will be solely responsible for evaluating the outcomes. These will not participate in any other process. And they did not know the allocation of participants in their respective groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Phd, professor

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 1, 2022
• Study Start: July 30, 2023
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

BR (1)