Pompage and Photobiomodulation on Pain, Range of Motion, and Quality of Life in Patients With Neck Pain

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 Blinded Study

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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervicalgia
• Intervention / Treatment: Procedure: Pompage Technique (manual therapy); Device: Photobiomodulation (Placebo); Device: Photobiomodulation (Experimental)

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 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. 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Denise Cekaunaskas Kalil Lauand, pHD; Phone Number: +55(11)997710040; Email: dedekau@gmail.com
• Study Contact Backup: Name: Raquel Agneli Mesquita Ferrari, pHD; Phone Number: +55(11) 999192988; Email: raquelmesquita@uni9.pro.br

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 11030-480
      • Anna Carolina R.T. Horliana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Pompage and photobiomodulation (placebo); (1) Pompage Group + photobiomodulation placebo (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.	Procedure: Pompage Technique (manual therapy); To perform cervical Pompage the patient lies comfortably on their back or sits upright. The therapist locates the target area on the cervical spine. Using gentle pressure, the therapist applies traction to the cervical spine, stretching the muscles and fascia. The traction is held for 20 seconds. The therapist then releases the traction, allowing the cervical spine to return to its neutral position. This process will be repeated 3 times, with adjustments made based on the patient's response and comfort level.; Device: Photobiomodulation (Placebo); The photobiomodulation with a diode emitting light (LED) cluster device will be positioned on the cervical region of each patient (for 10 minutes each) with the device turned off (inactive), simulating the time with a recorded beep sound.
Experimental: Pompage + photobiomodulation (Experimental); (2) Pompage + photobiomodulation (PBM) 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.	Procedure: Pompage Technique (manual therapy); To perform cervical Pompage the patient lies comfortably on their back or sits upright. The therapist locates the target area on the cervical spine. Using gentle pressure, the therapist applies traction to the cervical spine, stretching the muscles and fascia. The traction is held for 20 seconds. The therapist then releases the traction, allowing the cervical spine to return to its neutral position. This process will be repeated 3 times, with adjustments made based on the patient's response and comfort level.; Device: Photobiomodulation (Experimental); The photobiomodulation with a diode emitting light (LED) cluster device will be positioned on the cervical region of each patient (for 10 minutes each).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain baseline	The Visual Analog Scale (VAS) consists of a visual graduated scale from 0 to 10 cm, where 0 represents the absence of pain and 10 represents very intense pain, used to measure the pain experienced by the patient. This scale will be used for assessment and to monitor treatment progression. The patient is asked about the intensity of their pain, and the corresponding number on the scale is marked.	Baseline
Pain at the end	The Visual Analog Scale (VAS) consists of a visual graduated scale from 0 to 10 cm, where 0 represents the absence of pain and 10 represents very intense pain, used to measure the pain experienced by the patient. This scale will be used for assessment and to monitor treatment progression. The patient is asked about the intensity of their pain, and the corresponding number on the scale is marked.	At the 50th day of the protocol (at the end of Session 10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical Range of Motion at baseline	The Goniometer is an instrument used to measure the degrees of range of motion (ROM) of the cervical region, with normal standards considered as follows: flexion from 0 to 65 degrees; extension from 0 to 50 degrees; lateral flexion to the right and left from 0 to 40 degrees; right and left rotation from 0 to 55 degrees. It will be used for assessment and monitoring of treatment progression.	Baseline
Cervical Range of Motion at the end	The Goniometer is an instrument used to measure the degrees of range of motion (ROM) of the cervical region, with normal standards considered as follows: flexion from 0 to 65 degrees; extension from 0 to 50 degrees; lateral flexion to the right and left from 0 to 40 degrees; right and left rotation from 0 to 55 degrees. It will be used for assessment and monitoring of treatment progression.	At the 50th day of the protocol (at the end of Session 10)
Quality of Life at baseline	To assess the quality of life of the participants, the WHOQOL-BREF will be utilized, an abbreviated instrument developed by the World Health Organization. This questionnaire will consist of 26 items distributed across four main domains: Physical, Psychological, Social Relationships, and Environment. Each item will be rated on a 5-point Likert scale, ranging from 1 ("not at all") to 5 ("extremely"). The scores for each domain will be calculated from the averages of the corresponding item responses, multiplied by 4 to transform the results into a scale of 0 to 100. Higher scores will indicate a better perception of quality of life in the specific domain	Baseline
Quality of Life at the end	To assess the quality of life of the participants, the WHOQOL-BREF will be utilized, an abbreviated instrument developed by the World Health Organization. This questionnaire will consist of 26 items distributed across four main domains: Physical, Psychological, Social Relationships, and Environment. Each item will be rated on a 5-point Likert scale, ranging from 1 ("not at all") to 5 ("extremely"). The scores for each domain will be calculated from the averages of the corresponding item responses, multiplied by 4 to transform the results into a scale of 0 to 100. Higher scores will indicate a better perception of quality of life in the specific domain	At the 50th day of the protocol (at the end of Session 10)
Degree of Functional Disability at the baseline	The Neck Disability Index (NDI) questionnaire, which assesses the degree of functional disability of the cervical region, is a self-administered questionnaire consisting of 10 sessions with 6 responses, reflecting 6 stages of functional disability, with scores ranging from 0 to 5, where 0 represents the lowest and 5 represents the highest level of disability.	Baseline
Degree of Functional Disability at the end	The Neck Disability Index (NDI) questionnaire, which assesses the degree of functional disability of the cervical region, is a self-administered questionnaire consisting of 10 sessions with 6 responses, reflecting 6 stages of functional disability, with scores ranging from 0 to 5, where 0 represents the lowest and 5 represents the highest level of disability.	At the 50th day of the protocol (at the end of Session 10)

Collaborators and Investigators

• Sponsor: University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Estimated): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: neck pain; manual therapy; photobiomodulation; LED
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 77505024300005511

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No