NCT04396691

Brief Summary

The objective of the study is to detect the state of clinical and instrumental factors related in fighter pilots with non-specific mechanical neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

March 8, 2021

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2021

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

7 days

First QC Date

May 19, 2020

Last Update Submit

June 14, 2023

Conditions

Keywords

nonspecific chronic neck painfighter pilots

Outcome Measures

Primary Outcomes (2)

  • Range of movement

    For the evaluation of cervical ROM, we will use a conventional two-branch goniometer, from the EnrafNonius® brand. Subjects will be placed in a sitting position on a stool, with a neutral neck and head position. The range of active cervical mobility presented by the patients was measured in reference to the three planes of the space. In the sagittal plane, the degrees of mobility to flexion and extension were measured, in the frontal plane the right and left inclinations, and in the transverse plane both rotations.

    1 week

  • Disability

    The degree of cervical disability involvement was measured through the Neck Disability Index (NDI), translated into Spanish, presenting optimum reliability and internal validity. It consists of 10 sections, 4 of them are related to subjective symptoms and the other 6 are related to basic activities of daily life. Each of the sections presents 6 possible responses, scoring these from 0 to 5 according to progression of functional disability. Scores less than 5 points indicate non-disability, between 5-14 points indicates mild disability, values between 30-48 points moderate disability, between 50-64 points severe disability and those that exceed 70 points represent complete disability.

    1 week

Secondary Outcomes (4)

  • Pressure pain thresholds

    1 week

  • Surface electromyographic

    1 week

  • Kinesophobia

    1 week

  • Catastrophic pain

    1 week

Study Arms (2)

Instructors group

Group of flight instructors at the reactor school.

Students group

Group of students at the reactor school.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The selection of the sample was made in the accessible population of the Talavera la Real Air Base (Badajoz).

You may qualify if:

  • Numerical pain rating scale. Participants rated the intensity of their neck pain at rest on an 11-point Numeric Pain Rating Scale (NPRS), where 0 was no pain and 10 maximum pain .The pilots airforce were asked to indicate the pain levels that they experienced when they wake up in the morning. Cleland et al reported that the minimal detectable change (MDC) and minimal clinically important difference (MCID) for the numeric pain rating scale were 1.3 and 2.1 points, respectively, in patients with mechanical neck pain.
  • Joint Position Sense. This test assesses the ability to relocate the head to its natural posture, and is a test of cervical proprioception. It consists of a visual measurement of error in moving the head to the initial neutral position after active cervical rotation. If the average difference between the initial and final position is equivalent to an error of 4.5 degrees, it is considered abnormal and the subject could be included in the study.

You may not qualify if:

  • Cervical pain that occurs with irradiation to the upper limbs and / or radiculopathy.
  • Cervical spine surgery.
  • Have received physical therapy treatment six weeks prior to data collection.
  • Being involved in an on-going medico-legal dispute.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Extremadura

Badajoz, 06006, Spain

Location

Related Publications (12)

  • Jensen MP, Turner JA, Romano JM, Fisher LD. Comparative reliability and validity of chronic pain intensity measures. Pain. 1999 Nov;83(2):157-62. doi: 10.1016/s0304-3959(99)00101-3.

    PMID: 10534586BACKGROUND
  • Cleland JA, Childs JD, Whitman JM. Psychometric properties of the Neck Disability Index and Numeric Pain Rating Scale in patients with mechanical neck pain. Arch Phys Med Rehabil. 2008 Jan;89(1):69-74. doi: 10.1016/j.apmr.2007.08.126.

    PMID: 18164333BACKGROUND
  • Chesterton LS, Sim J, Wright CC, Foster NE. Interrater reliability of algometry in measuring pressure pain thresholds in healthy humans, using multiple raters. Clin J Pain. 2007 Nov-Dec;23(9):760-6. doi: 10.1097/AJP.0b013e318154b6ae.

    PMID: 18075402BACKGROUND
  • Hapidou EG, O'Brien MA, Pierrynowski MR, de Las Heras E, Patel M, Patla T. Fear and Avoidance of Movement in People with Chronic Pain: Psychometric Properties of the 11-Item Tampa Scale for Kinesiophobia (TSK-11). Physiother Can. 2012 Summer;64(3):235-41. doi: 10.3138/ptc.2011-10.

    PMID: 23729957BACKGROUND
  • 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.

    PMID: 20926355BACKGROUND
  • Calamita SAP, Biasotto-Gonzalez DA, De Melo NC, Fumagalli MA, Amorim CF, de Paula Gomes CAF, Politti F. Immediate Effect of Acupuncture on Electromyographic Activity of the Upper Trapezius Muscle and Pain in Patients With Nonspecific Neck Pain: A Randomized, Single-Blinded, Sham-Controlled, Crossover Study. J Manipulative Physiol Ther. 2018 Mar-Apr;41(3):208-217. doi: 10.1016/j.jmpt.2017.09.006.

    PMID: 29549891BACKGROUND
  • Sullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess. 1995;7(4):524.

    BACKGROUND
  • Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.

    PMID: 1834753BACKGROUND
  • Peterson-Kendall F, Kendall-McCreary E, Geise-Provance P, McIntyre-Rodgers M, Romani W. Muscles testing and function with posture and pain. US Lippincott Williams Wilkins Ltd. 2005;49-118.

    BACKGROUND
  • MacDermid JC, Walton DM, Avery S, Blanchard A, Etruw E, McAlpine C, Goldsmith CH. Measurement properties of the neck disability index: a systematic review. J Orthop Sports Phys Ther. 2009 May;39(5):400-17. doi: 10.2519/jospt.2009.2930.

    PMID: 19521015BACKGROUND
  • Kovacs FM, Bago J, Royuela A, Seco J, Gimenez S, Muriel A, Abraira V, Martin JL, Pena JL, Gestoso M, Mufraggi N, Nunez M, Corcoll J, Gomez-Ochoa I, Ramirez MJ, Calvo E, Castillo MD, Marti D, Fuster S, Fernandez C, Gimeno N, Carballo A, Milan A, Vazquez D, Canellas M, Blanco R, Brieva P, Rueda MT, Alvarez L, Del Real MT, Ayerbe J, Gonzalez L, Ginel L, Ortega M, Bernal M, Bolado G, Vidal A, Ausin A, Ramon D, Mir MA, Tomas M, Zamora J, Cano A. Psychometric characteristics of the Spanish version of instruments to measure neck pain disability. BMC Musculoskelet Disord. 2008 Apr 9;9:42. doi: 10.1186/1471-2474-9-42.

    PMID: 18400084BACKGROUND
  • Revel M, Andre-Deshays C, Minguet M. Cervicocephalic kinesthetic sensibility in patients with cervical pain. Arch Phys Med Rehabil. 1991 Apr;72(5):288-91.

    PMID: 2009044BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Carlos Fernández-Morales, PT, MSc

    Universidad de Extremadura

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, MSc

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 20, 2020

Study Start

March 8, 2021

Primary Completion

March 15, 2021

Study Completion

April 20, 2021

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations