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

NCT06416527 | Not Yet Recruiting

• 1 other identifier: 77505024300005511
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervicalgia

Keywords

neck pain; photobiomodulation; LED; manual therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Cervical Range of Motion at baseline

  Baseline

• Cervical Range of Motion at the end

  At the 50th day of the protocol (at the end of Session 10)

• Quality of Life at baseline

  Baseline

• Quality of Life at the end

  At the 50th day of the protocol (at the end of Session 10)

• Degree of Functional Disability at the baseline

  Baseline

Study Arms (2)

Pompage and photobiomodulation (placebo)

PLACEBO COMPARATOR

(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); Device: Photobiomodulation (Placebo)

Pompage + photobiomodulation (Experimental)

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.

Device: Photobiomodulation (Experimental); Procedure: Pompage Technique (manual therapy)

Interventions

Photobiomodulation (Experimental) DEVICE

The photobiomodulation with a diode emitting light (LED) cluster device will be positioned on the cervical region of each patient (for 10 minutes each).

Pompage + photobiomodulation (Experimental)

Pompage Technique (manual therapy) PROCEDURE

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.

Pompage + photobiomodulation (Experimental); Pompage and photobiomodulation (placebo)

Photobiomodulation (Placebo) DEVICE

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.

Pompage and photobiomodulation (placebo)

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

UNINOVE

São Paulo, São Paulo, 11030-480, Brazil

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Low-Level Light Therapy; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Complementary Therapies; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Denise Cekaunaskas Kalil Lauand, pHD

CONTACT

+55(11)997710040; dedekau@gmail.com

Raquel Agneli Mesquita Ferrari, pHD

CONTACT

+55(11) 999192988; raquelmesquita@uni9.pro.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study will be conducted by a team of researchers, including one researcher who will supervise the interventions, i.e., the application of pompages associated or not with PBM using LED clusters. This researcher will be the only one to know the intervention performed on each participant. Another researcher will conduct the initial assessment of outcomes and reevaluations (blinded to the experimental and control groups). The statistical analysis will also be performed blindly by a statistician who will receive the data without identification of the group. The patient will be blinded to the treatment with PBM (or its simulation).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 16, 2024
• Study Start: December 30, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-09

Locations

BR (1)