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Neck PainNCT04396691

Clinimetric and Instrumental Characterization of Fighter Pilots With Flight-related Neck Pain.

An observational study of Neck Pain, run by Universidad de Extremadura at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Neck Pain
How many people
18 participants
Where
1 siteSpain
Study dates
8 Mar 2021to 20 Apr 2021
How long will I take part?
4 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad de Extremadura

    Badajoz, 06006

Other trials in Spain

About this study

Official title: Clinimetric and Instrumental Characterization of Fighter Pilots With Flight-related Neck Pain. Observational Study

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.

Read the detailed description

A prevalence study (descriptive, observational, cross-sectional) was carried out, in which clinimetric variables (range of active cervical movement, motor control and electrical activity), perceived pain (using NSMNP and algometry) and disability were evaluated. The sample (n = 18) is divided into instructors (n = 7) and students (n = 11). The objective of this study is to characterize descriptively at the sociodemographic level and to know the state of health in relation to clinimetric variables of the fighter pilots of the Talavera la Real air base (Badajoz) to determine the risk of developing an neck injury.

Conditions
Neck Pain
Keywords
nonspecific chronic neck pain, fighter pilots
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04396691
Study groupRoleWhat they receive
Instructors groupGroup of flight instructors at the reactor school.
Students groupGroup of students at the reactor school.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 week

  2. 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.

    Measured: 1 week

Secondary outcomes (4)

  1. Pressure pain thresholds

    A mechanical pressure Fisher algometer (Force Dial model FDK 40) with a 1 cm² area contact head was used to measure the pressure pain threshold. The reliability of pressure algometry has been found to be high [intraclass correlation coefficient = 0.91 (95% confidence interval, 0.82-0.97)]. With the participant in supine, the pressure pain threshold of the the myofascial trigger point nº2 of the upper trapezius muscle according to Travell and Simons and the central trigger point of the sternocleidomastoid muscle was bilaterally evaluated. Also, in sitting position the pressure pain threshold of the myofascial trigger point of the scapula elevator muscle was bilaterally evaluated. The minimal clinically important difference (MCDI) is 1.2 Kg/cm2.

    Measured: 1 week

  2. Surface electromyographic

    The electromyography (EMG) signal of the upper trapezius muscle was recorded during 3 step contractions of shoulder elevation force (15%-30% maximal voluntary contraction). Se tomo el valor más alto de las tres contracciones. The signal of the sternocleidomastoid muscle was recorded during 3 billateraly step contractions of neck flexión and antepulsion neck force. Both contractions were performed in a combined and simultaneous movement, recreating the movement produced by the reaction forces in the takeoff and landing of the fighter jet. Both movements were made at 15%-30% maximal voluntary contraction, as used by Calamita et al on the same musculature in subjects with nonspecific neck pain.

    Measured: 1 week

  3. Kinesophobia

    The Spanish version of the TSK-11 was used to measure fear of movement. Higher scores indicate greater fear-avoidance behaviors. The TSK-11 has demonstrated acceptable internal consistency and validity.

    Measured: 1 week

  4. Catastrophic pain

    The Pain Catastrophizing Scale (PCS) is a self-administered scale of 13 items and one of the most used to assess catastrophism of pain. The subjects take their past painful experiences as a reference and indicate the degree to which they experienced each of the 13 thoughts or feelings on a 5-point Líkert scale ranging from 0 (never) to 4 (always). The theoretical range of the instrument is between 13 and 62, indicating low scores, little catastrophism, and high values, high catastrophism.

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2020
  2. Study start8 Mar 2021
  3. Primary completion15 Mar 2021
  4. Study completion20 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
18 participants (actual)
Target duration
4 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04396691
Sponsor's protocol ID
01
Status last verified
Jun 2023
First submitted
19 May 2020
Last updated
15 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 10534586

  • 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.

    PubMed 18164333

  • 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.

    PubMed 18075402

  • 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.

    PubMed 23729957

  • 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.

    PubMed 20926355

  • 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.

    PubMed 29549891

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

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

    PubMed 1834753

  • 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.

  • 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.

    PubMed 19521015

  • 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.

    PubMed 18400084

  • 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.

    PubMed 2009044

Questions about this trial

What is this clinical trial studying?

An observational study of Neck Pain, run by Universidad de Extremadura at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Range of movement (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04396691, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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