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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05400473
• Other study ID #: 58616022.1.0000.5511
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2023
• Est. completion date: July 25, 2025

Study information

• Verified date: March 2024
• Source: University of Nove de Julho
• Contact: Cid Gomes, Phd
• Phone: +5511970941936
• Email: cid.andre[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 25, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Neck Pain

Intervention

Other:
• Therapeutic exercise
This group will consist of 30 participants. A program consisting of specific therapeutic exercises for the cervical region will be applied.
• Photobiomodulation
Photobiomodulation will be applied on the cervical region. To perform the photobiomodulation protocol, a low power infrared laser therapy unit will be used.

Locations

Country	Name	City	State
Brazil	University of Nove de Julho	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Cid André Fidelis de Paula Gomes

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 5 weeks of intervention and 4 weeks after the end of the intervention.
Primary	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 5 weeks of intervention and 4 weeks after the end of the intervention.
Secondary	Catastrophic Thoughts about Pain Scale	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.	Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Secondary	Kinesiophobia Tampa Scale	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.	Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.]
Secondary	The Copenhagen Neck Functional Disability Scale (CNFDS)	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.	Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.]
Secondary	Global Perception of Change scale	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.	Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.]