Neck PainNCT05400473
Effects of Adding Photobiomodulation to a Specific Therapeutic Exercise Program for the Treatment of Individuals With Chronic Nonspecific Neck Pain.
A study testing Therapeutic exercise and Photobiomodulation in people with Neck Pain and Chronic Pain, run by Cid André Fidelis de Paula Gomes at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain, Chronic Pain
- What is being tested?
- Therapeutic exercise and Photobiomodulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jul 2023to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Therapeutic exercise, Photobiomodulation
- Medical subject headings
- Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exerciseOther
This group will consist of 30 participants. A program consisting of specific therapeutic exercises for the cervical region will be applied.
PhotobiomodulationOther
Photobiomodulation will be applied on the cervical region. To perform the photobiomodulation protocol, a low power infrared laser therapy unit will be used.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Therapeutic exercise; Other: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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'.
Measured: 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
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.
Measured: Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.
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.
Measured: Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.
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.
Measured: Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.
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.
Measured: Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start30 Jul 2023
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cid André Fidelis de Paula Gomes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cid André Fidelis de Paula Gomes, University of Nove de Julho
- Investigators
- Cid Gomes, Phd, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400473
- Sponsor's protocol ID
- 58616022.1.0000.5511
- Status last verified
- Mar 2025
- First submitted
- 27 May 2022
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Make data available remotely in digital cloud storage.
Publications
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.
PubMed 38961460
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adding Photobiomodulation to a Specific Therapeutic Exercise Program for the Treatment of Individuals With Chronic Nonspecific Neck Pain.
- ClinicalTrials.gov ID
- NCT05400473
- Acronym / sponsor ID
- 58616022.1.0000.5511
- Conditions
- Neck Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Cid André Fidelis de Paula GomesUniversity, hospital or other
- Study start
- 30 Jul 2023 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic exercise group | Active comparator | Other: Therapeutic exercise1.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. |
| Therapeutic exercise group + photobiomodulation | Experimental | Other: Therapeutic exercise, Other: PhotobiomodulationThis 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic exerciseThis group will consist of 30 participants. A program consisting of specific therapeutic exercises for the cervical region will be applied. | Other | Therapeutic exercise group, Therapeutic exercise group + photobiomodulation |
| PhotobiomodulationPhotobiomodulation will be applied on the cervical region. To perform the photobiomodulation protocol, a low power infrared laser therapy unit will be used. | Other | Therapeutic exercise group + photobiomodulation |
Primary outcome
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.
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'.
4 secondary outcomes
Catastrophic Thoughts about Pain Scale
Time frame: Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.
Kinesiophobia Tampa Scale
Time frame: Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.
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.
Global Perception of Change scale
Time frame: Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Derived from this study: PubMed 38961460Barbosa 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.
- Individual participant dataSharing planned: Undecided. Make data available remotely in digital cloud storage.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cid Gomes, Phd principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercise and Photobiomodulation in people with Neck Pain and Chronic Pain, run by Cid André Fidelis de Paula Gomes at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional disability (time frame: Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05400473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.