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Completed

NCT Number: NCT05400473

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

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.

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Key information

Conditions

Neck Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nove de Julho

São Paulo, 01504-001, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapeutic exercise

Other

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

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.

Primary outcomes

  1. Functional disability

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

    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.

  2. Numerical Pain Scale

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

    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'.

Secondary outcomes

  1. Catastrophic Thoughts about Pain Scale

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

    The Catastrophic Thoughts About Pain Scale will be used to assess pain-related catastrophizing. Thirteen items rated on 5 pont likert scales (0) not at all (4) all time. Higher score indicates higher level of Catastrophizing.

  2. Kinesiophobia Tampa Scale

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

    Tampa Kinesiophobia Scale will be used to assess fear of movement and injury recurrence. The TSK consists of 17 questions that assess fear of move- ment. The score for each item ranges from 1 to 4, where 1 represents ''strongly disagree'', 2 ''somewhat disagree'', 3 ''somewhat agree'', and 4 ''strongly agree''. For the final score, it is necessary to reverse the scores of questions 4, 8, 12, and 16. The total score varies between 17 and 68 points, and a higher score represents greater kinesiophobia.

  3. The Copenhagen Neck Functional Disability Scale (CNFDS)

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

    The CNFDS is a one-dimensional self-report scale consisting of 15 items that assess the degree of disability in activities of daily living in patients diagnosed with neck pain. When calculating the CNFDS score, the following procedures should be considered: For items 1 to 5, the answer "yes" = 0, "sometimes" = 1 and "no" = 2; For items 6 to 15, the answer "yes" = 2, "sometimes" = 1 and "no" = 0. Thus, the total score ranges from 0 to 30, the higher the score, the greater the disability.

  4. Global Perception of Change scale

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

    The perception of the global effect of the treatment by the research participant will be evaluated by the Global Perception of Change scale. The Global Perception of Change scale is a direct scale on the patient's self-perception when the intervention is performed. This scale consists of 11 points, ranging from -5 (worsening compared to the start of treatment), 0 (neutral) and +5 (improvement compared to the start of treatment), using the Portuguese version.

Sponsors and collaborators

Lead sponsor

Cid André Fidelis de Paula Gomes

Unknown

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 1, 2022
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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