NCT05541848

Brief Summary

The aim of this study was to analyse the immediate effects of a 4-week multimodal physiotherapy program which combines cervical supervised exercises with laser-guided feedback (ELGF) and interferential current electro massage (ICE) in fighter pilots with flight-related neck pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2022

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

26 days

First QC Date

September 12, 2022

Last Update Submit

March 18, 2024

Conditions

Keywords

fighter pilotsflight-related neck paindisabilityelectric massageTherapeutic exercise

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Rating Scale (NPRS)

    Numeric Pain Rating Scale (NPRS) is a 11-point numeric rating scale, where 0 denotes "no pain" and 10 denotes "the maximum bearable pain". The minimum clinically important difference (MCID) for this tool has been established at 1.5 points and the minimum detectable change (MDC) at 2.6 points, in individuals with neck pain. The NPRS is a valid scale with moderate test-retest reliability in this population (Intraclass Coefficient Correlation (ICC): 0.76, 95% CI 0.58 to 0.93).

    4 weeks.

  • Cervical Joint Position Sense Error (JPSE)

    This test consists of a visual measurement of the error in moving the head to the initial neutral position after active cervical rotation.

    4 weeks.

Secondary Outcomes (18)

  • Cervical Range of Motion (CRoM)

    4 weeks.

  • Pressure Pain Threshold (PPT)

    4 weeks.

  • Standard Deviation 1 (SD1)

    4 weeks.

  • Standard Deviation 2 (SD2)

    4 weeks.

  • Min_HR

    4 weeks.

  • +13 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

Participants in the control group will not receive any intervention and will continue with their normal combat and flight exercise activities. They will be asked not to take medication or seek alternative treatments.

Experimental group

EXPERIMENTAL

Participants in the experimental group will follow a supervised ELGF program. Subsequently, they will receive an intervention based on manual therapy combined with electrical stimulation called electro-massage.

Other: Cervical supervised exercises with laser-guided feedback (ELGF)Other: Interferential current electro massage (ICE)

Interventions

Cervical supervised exercises with laser-guided feedback (ELGF) is defined as a procedure of proprioceptive training based on a type of therapeutic exercise that provides external feedback to exercise, achieving an improvement in range of motion and postural control in subjects with spinal pain. For the performance of the exercise program, "Motion Guidance Clinician Kit" (Motion Guidance LLC, Denver, CO, USA.) was used. The program consisted of 4 exercises, which progressed in difficulty according to the tolerance achieved over the course of the sessions: a) Maintaining the head position (cervical stabilisation); b) Cervical flexion-extension; c) Right-left rotations; d) Right-left lateral-flexions. Each exercise consisted of 4 series of 8 repetitions, except the first one, in which the head position is maintained by pointing the laser at the centre of the panel for 30 seconds (4 series). The average time to complete the entire program did not exceed 14 minutes.

Experimental group

Interferential current electro-massage (ICE) is defined as a technique which combines simultaneously manual therapy (massage) and ICT. We used a current bipolar mode, using a carrier frequency of 4000 Hz at constant voltage and an amplitude-modulated frequency of 100 Hz (Sonopuls 692®; Enraf-Nonius BV, Rotterdam, The Netherlands), was administered. The intensity was set to provide a strong and comfortable tingling, without evoking muscle twitches even though a slight vibration (fasciculation) was allowed. The sequence combined (A) superficial stroke over the neck-shoulder for 30-45 seconds; (B) deep sliding movements, alone or (C) combined with shoulder drop, for 4-5 minutes; (D) bilateral kneading of the upper trapezius (4-5 minutes); (E) slight stretching of cervical muscles (upper trapezius, sternocleidomastoid, and levator scapulae); and repetition of step (A). The electro-massage protocol lasted 15 minutes.

Experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Flight pilots (male and female) who, at the time of the assessment, were an instructor or student attached to the 23th Wing of Talavera Air Base, Spanish Air Force (SAF), Badajoz.
  • Flight pilots diagnosed with flight-related neck pain according to the International Classification proposed by an expert panel of the North Atlantic Treaty Organisation (NATO).
  • A minimum perceived pain of 3/10 on the Visual Analogue Scale (VAS) in the early-morning assessment.
  • Scores of ≥5 points on the Neck Disability Index (NDI), and a cervical-repositioning error of ≥4.5°.

You may not qualify if:

  • Cervical pain with radiation to the upper limbs and/or radiculopathy.
  • Cervical spine surgery with or without the presence of a metal implant.
  • Having received physiotherapy or any other routine medical care six weeks prior to data collection.
  • Being involved in ongoing medical-legal conflicts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Extremadura

Badajoz, 06006, Spain

Location

Related Publications (23)

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    BACKGROUND
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    PMID: 2009044BACKGROUND
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    PMID: 33187565BACKGROUND
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    PMID: 24834567BACKGROUND
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    PMID: 20170780BACKGROUND
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    PMID: 22592882BACKGROUND
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    PMID: 23221624BACKGROUND
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    PMID: 18164347BACKGROUND
  • Barbero M, Bertoli P, Cescon C, Macmillan F, Coutts F, Gatti R. Intra-rater reliability of an experienced physiotherapist in locating myofascial trigger points in upper trapezius muscle. J Man Manip Ther. 2012 Nov;20(4):171-7. doi: 10.1179/2042618612Y.0000000010.

    PMID: 24179324BACKGROUND
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    PMID: 28440895BACKGROUND
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    PMID: 27779951BACKGROUND
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    PMID: 15828638BACKGROUND
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    PMID: 33329060BACKGROUND
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    PMID: 29549891BACKGROUND
  • Gomez-Perez L, Lopez-Martinez AE, Ruiz-Parraga GT. Psychometric Properties of the Spanish Version of the Tampa Scale for Kinesiophobia (TSK). J Pain. 2011 Apr;12(4):425-35. doi: 10.1016/j.jpain.2010.08.004.

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  • Fernandez-Morales C, Espejo-Antunez L, Cardero-Duran MLA, Falla D, Moreno-Vazquez JM, Albornoz-Cabello M. Psychophysiological responses to a multimodal physiotherapy program in fighter pilots with flight-related neck pain: A pilot trial. PLoS One. 2024 Jul 5;19(7):e0306708. doi: 10.1371/journal.pone.0306708. eCollection 2024.

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Luis Espejo-Antúnez, PhD

    University of Extremadura

    STUDY DIRECTOR
  • Carlos Fernández-Morales, PT, MSc

    University of Extremadura

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 15, 2022

Study Start

September 15, 2022

Primary Completion

October 11, 2022

Study Completion

December 14, 2022

Last Updated

March 20, 2024

Record last verified: 2024-03

Locations