Chronic Pain, Neck Pain
Conditions
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.
Interventions
OTHERTherapeutic exercise
This group will consist of 30 participants. A program consisting of specific therapeutic exercises for the cervical region will be applied.
OTHERPhotobiomodulation
Photobiomodulation will be applied on the cervical region. To perform the photobiomodulation protocol, a low power infrared laser therapy unit will be used.
Sponsors
Cid André Fidelis de Paula Gomes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional disability | 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. |
| Numerical Pain Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Catastrophic Thoughts about Pain Scale | 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. |
| Kinesiophobia Tampa Scale | 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. |
| The Copenhagen Neck Functional Disability Scale (CNFDS) | 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. |
| Global Perception of Change scale | 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. |
Countries
Brazil
Outcome results
None listed