Clinical trial NCT05400473: Effects of Adding Photobiomodulation to a Specific Therapeutic Exercise Program for the Treatment of Individuals With Chronic Nonspecific Neck Pain.
Official title: Effects of Adding Photobiomodulation to a Specific Therapeutic Exercise Program for the Treatment of Individuals With Chronic Nonspecific Neck Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Chronic Pain
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Functional disability
timeFrame: Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.
measure: Numerical Pain Scale
timeFrame: Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.
Secondary outcomes:
measure: Catastrophic Thoughts about Pain Scale
timeFrame: Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.
measure: Kinesiophobia Tampa Scale
timeFrame: Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.
measure: The Copenhagen Neck Functional Disability Scale (CNFDS)
timeFrame: Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.
measure: Global Perception of Change scale
timeFrame: Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Nove de Julho
Study officials:
affiliation: University of Nove de Julho
name: Cid Gomes, Phd
role: PRINCIPAL_INVESTIGATOR
References: