Clinical trial NCT06416527: Pompage and Photobiomodulation on Pain, Range of Motion, and Quality of Life in Patients With Neck Pain
Official title: Effects of Pompage Associated or Not With Photobiomodulation on Pain, Range of Motion, and Quality of Life in Patients With Neck Pain: a Controlled, Randomized, and Double Blinded Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervicalgia
Keywords: neck pain
photobiomodulation
LED
manual therapy
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants will be divided into 2 groups:

1. Pompage Group (Control): Patients will receive treatment through the application of the pompage technique in the cervical region during 10 sessions performed 3 times per week, excluding weekends.
2. Pompage + FBM Group (Experimental): Treatment will consist of 10 sessions in which the pompage technique will be applied associated with photobiomodulation in the form of LED cluster in the cervical region, performed 3 times per week, excluding weekends.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effects of Pompage associated or not with PBM, using a cluster of LEDs, on pain and neck disability. This controlled, randomized, and double-blinded clinical study includes participants of both genders, aged 18 to 55, with non-specific chronic neck pain will be included. Participants will be randomized into two groups: (1) Pompage (n=28) focusing only on manual therapy through Pompage technique and (2) Pompage + PBM Group (n=28) involving the same procedures as the first group, followed by PBM with a LED cluster applied for 10 minutes to the neck region for 10 sessions. Pain and functional disability will be assessed using the visual analog scale (VAS) and Neck Pain Disability Index before and after the intervention. The resulting data will be submitted to statistical analysis considering α=0.05.

Detailed description: Chronic neck pain is a persistent condition affecting the spinal region, resulting in pain and restricted mobility. The management of neck pain often involves manual therapies, encompassing both passive and active interventions, aimed at alleviating pain, enhancing function, improving mobility, motor control, and reducing inflammatory processes. This pain can persist for at least three months and is considered non-specific when it is not associated with any specific underlying condition, such as inflammatory rheumatic disease, osteoporosis, cancer, or radiculopathy.

The use of lasers and LEDs for photobiomodulation (PBM) represents an advantageous approach to treating neck pain, given their demonstrated therapeutic efficacy in the literature. Moreover, these resources are non-invasive and easy to apply, making them an attractive option for both patients and healthcare professionals. Therefore, the aim of this study is to evaluate the effects of Pompage associated or not with PBM, using a cluster of LEDs, on pain and neck disability. This controlled, randomized, and double-blinded clinical study includes participants of both genders, aged 18 to 62, with non-specific chronic neck pain will be included. Participants will be randomized into two groups: (1) Pompage (n=28) focusing only on manual therapy through Pompage technique and (2) Pompage + PBM Group (n=28) involving the same procedures as the first group, followed by PBM with a LED cluster applied for 10 minutes to the neck region. The treatment protocol consists of 10 sessions, three times weekly, excluding weekends. For PBM, a cluster comprising 264 LEDs (8 mW; 4.89J; 9.6 J/cm2; 16 mW/cm² per LED) will be used, with 132 red (660nm) and 132 infrared (850nm) LEDs. Pain and functional disability will be assessed using the visual analog scale (VAS) and Neck Pain Disability Index before and after the intervention. The resulting data will be submitted to statistical analysis considering α=0.05.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 62 years;
* Both genders;
* Without comorbidities.

Exclusion Criteria:

* Presentation of rheumatic or degenerative diseases in the cervical region;
* Undergoing orthodontic or physiotherapeutic treatment;
* Initiation of the use of any medication during any phase of the study;
* Using bite plate.

Primary outcomes:
measure: Pain baseline
timeFrame: Baseline
measure: Pain at the end
timeFrame: At the 50th day of the protocol (at the end of Session 10)
Secondary outcomes:
measure: Cervical Range of Motion at baseline
timeFrame: Baseline
measure: Cervical Range of Motion at the end
timeFrame: At the 50th day of the protocol (at the end of Session 10)
measure: Quality of Life at baseline
timeFrame: Baseline
measure: Quality of Life at the end
timeFrame: At the 50th day of the protocol (at the end of Session 10)
measure: Degree of Functional Disability at the baseline
timeFrame: Baseline
measure: Degree of Functional Disability at the end
timeFrame: At the 50th day of the protocol (at the end of Session 10)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: UNINOVE
state: SP
Study officials:
References: