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NCT01772706 · OUTCOME

Number of Patients by Pain Intensity Category at Final Treatment Session With Numeric Rating Scale (NRS)

Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer · Source last updated 2026-07-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Assessment at Week 7, corresponding to the completion of concomitant chemoradiotherapy.

What was measured

Pain intensity is evaluated at the final treatment session using a Numeric Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain), with scores categorized as 0 (no pain), 1-3 (mild pain), 4-6 (moderate pain), and 7-10 (severe pain).

Analysis population: Analyses were performed on available data; patients with missing outcome data were not included in the corresponding analysis. No imputation on missing data was provided

Groups in this outcome

Laser Low-level Energy Functional

The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus. low level laser therapy

Laser Low-level Energy Nonfunctional

The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute. placebo (laser low level energy nonfunctional)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Laser Low-level Energy Functional40
Laser Low-level Energy Nonfunctional37

Reported measurements

Source class 1

0 (No pain)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Laser Low-level Energy Functional10Not reportedNot reportedNot reportedNot reported
Laser Low-level Energy Nonfunctional11Not reportedNot reportedNot reportedNot reported

1-3 (Mild pain)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Laser Low-level Energy Functional15Not reportedNot reportedNot reportedNot reported
Laser Low-level Energy Nonfunctional8Not reportedNot reportedNot reportedNot reported

4-6 (Moderate pain)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Laser Low-level Energy Functional9Not reportedNot reportedNot reportedNot reported
Laser Low-level Energy Nonfunctional11Not reportedNot reportedNot reportedNot reported

7-10 (Severe pain)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Laser Low-level Energy Functional6Not reportedNot reportedNot reportedNot reported
Laser Low-level Energy Nonfunctional7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        11
      title
      0 (No pain)
    2. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        8
      title
      1-3 (Mild pain)
    3. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        11
      title
      4-6 (Moderate pain)
    4. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        7
      title
      7-10 (Severe pain)
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      37
    units
    Participants
description
Pain intensity is evaluated at the final treatment session using a Numeric Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain), with scores categorized as 0 (no pain), 1-3 (mild pain), 4-6 (moderate pain), and 7-10 (severe pain).
groups
  1. description
    The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus. low level laser therapy
    id
    OG000
    title
    Laser Low-level Energy Functional
  2. description
    The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute. placebo (laser low level energy nonfunctional)
    id
    OG001
    title
    Laser Low-level Energy Nonfunctional
param Type
COUNT_OF_PARTICIPANTS
population Description
Analyses were performed on available data; patients with missing outcome data were not included in the corresponding analysis. No imputation on missing data was provided
reporting Status
POSTED
time Frame
Assessment at Week 7, corresponding to the completion of concomitant chemoradiotherapy.
title
Number of Patients by Pain Intensity Category at Final Treatment Session With Numeric Rating Scale (NRS)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice