AzTrials
AzTrials

PainACROPOSENCT02625896

Free Fall Acrobatics to Reduce Neck Loads During Parachute Opening Shock: Evaluation of an Intervention.

A study testing Intervention in people with Pain and Athletic Injuries, run by Karolinska Institutet at 1 site in Sweden.

Completed

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

Official record
Search all trials

Trial summary

This study aims to evaluate the use of an aerial human body manoeuvre to reduce the biomechanical load on the neck of a parachutist during the parachute opening, in order to create a basis for future prevention of skydiver neck pain in the parachutist population. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Pain, Athletic Injuries, Whiplash Injuries
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteSweden
Study dates
17 Jun 2017to 14 Oct 2018
Phase
Interventional
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 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Holders of the highest parachute certification (level D) in the Swedish Parachute Association

Who cannot join

  • Ongoing neck problems
  • Pregnancy
  • Unwillingness to follow the safety regulations of the study
  • Known patch allergy
  • Participation in another concurrent biomedical study

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Karolinska Institutet

    Stockholm, 14183

Other trials in Sweden

About this study

This study aims to evaluate the use of an aerial human body manoeuvre to reduce the biomechanical load on the neck of a parachutist during the parachute opening, in order to create a basis for future prevention of skydiver neck pain in the parachutist population.

Read the detailed description

Elevated neck pain prevalence among skydivers is associated with exposure to repeated parachute openings. The parachute opening shock (POS) is a sudden and brutal deceleration of a human being. In skydiving (sport parachuting from aircraft), it slows a free falling skydiver from a velocity >200 km/h to <30 km/h within a few seconds. POS deceleration magnitudes 9-12 times Earth's gravitational acceleration (a dimensionless ratio denoted G) have been measured. These hard openings were painful, and a number of very hard openings have generated injuries visible to health care systems. During subjectively normal openings, decelerations measured on the human neck exceed 4 G with initial onset rates (jerks) exceeding 20 G/s. Considering that active skydivers may do ten jumps per day and may accumulate well over a thousand jumps during a parachuting career, these are problematic values. Fighter pilots have suffered neck pain after less accelerative exposure. In the Swedish skydiving population, the neck pain prevalence is 45%, to be compared with a general population estimate of 37%. Recently published data show that skydiver neck muscles are under excessive strain during POS, and data from our group suggest POS as composed of biomechanically discrete phases. A first phase contains an initial jerk in ventral to dorsal direction, i.e. "pulled backwards", denoted negative Gx, when the skydiver is rapidly rotated from a prone belly-to-earth body position to an upright position. During this phase, the moment arm from the center of mass of the head to the parachute connection point at the shoulders is long and likely to yield a high torque in the neck. The second phase, denoted positive Gz, contains the bulk of POS-deceleration directed caudally to cranially. Entering the second phase with the neck flexed forward from the jerk would put the neck muscles in a clear disadvantage.

In a sport, it would seem desirable to prevent injuries by the way the sport is practiced. A number of techniques to reduce POS neck loads have been suggested among athletes, two of which are biomechanically appealing: Reducing parachute deployment airspeed and positioning the human body head high prior to main parachute extraction. Whether these techniques actually reduce neck loads during POS has not been systematically evaluated. From an empirically determined relation between maximum POS deceleration and free fall velocity, it can be calculated that a decrease in velocity from 220 km/h to 190 km/h may reduce the maximum deceleration and thereby (constant mass) force 25%. Such a velocity reduction is possible using the human body only. Our static anthropometrical assessments suggest that, unless a flexion forward of the head occurs, pitching up the body head high to an angle of 45 degrees from the flat-belly-to-relative-wind plane may reduce the head-neck lever arm 30%. Thus, a successful combination of velocity reduction and head-neck lever arm reduction holds the promise of an approximately halved torque in the neck during POS. Such a substantial mechanical change can be hypothesized to have biological effects.

The intervention protocol is based on observational data and static anthropometrical calculations and inspired by anecdotal information. It has been systematically validated by subject matter experts, and the results of this validation has been published. The intervention is conceived as a combination of velocity reduction and head-neck lever arm reduction, main outcome variables being magnitudes of decelerations and jerks, expressed in G and G/s, respectively, and research subjects being experienced skydivers completing two consecutive skydives on the same day with random ordering (one being the control jump and one being the intervention jump).

Based on an estimated real-world 30% effect size and a desired 0.9 power level, sample size calculation suggest 16 subjects as sufficient for parametric analyses. To allow for dropout, the sample size will be increased to 20 subjects. Thus, twenty highly experienced skydivers will be recruited to the study, to perform the two consecutive terminal velocity skydives on the same day. Their demographics and background data will be obtained with use of a validated web-based questionnaire for skydivers. The test subjects will be recruited through electronic fora, including e-mail lists, for highly experienced skydivers. They will use their own sport parachute systems packed and maintained by themselves. The rationale for this is to maintain typical and comfortable conditions for each subject, whereas an unfamiliar system may introduce undesired psychomotor confounders, and also to maintain a high degree of external validity (as compared to using only one type of standardized parachute).

A detailed description of the planned measuring instrumentation has been published separately. The equipment setup in its entirety is approved for aerial use by the National Safety Officer of the Swedish Parachute Association. Multiple triaxial accelerometers are used to measure decelerations and jerks, and videography to record complex movements, including the parachute opening and head motion. Altitude and falling speed data will be collected with barometric and Global Positioning System (GPS) altimetry, using state-of-the-art skydiving devices.

Two consecutive skydives from 4000 m altitude will be completed by each subject on the same day; one being the control jump and one being the intervention jump. For safety reasons, main parachute terminal velocity deployment altitude will be elevated above normal and high-speed landings forbidden. In one of the two skydives, the test subject will perform an intervention consisting of a sequence of free fall manoeuvres performed using the human body: A free fall velocity reduction prior to main parachute deployment followed by a head high body attitude prior to main parachute extraction. Details of the manoeuvres will be given to the test subject in a written instruction.

This study will use a cross-over, within-subject, repeated measures design with random ordering of performing intervention jump or "ordinary" jump in the first jump of two. Computerized randomization will be performed in blocks, i.e. to have equal numbers of subjects starting with intervention jump vs. control jump in a block of every four subjects. A detailed description of the planned methodology for treatment and analysis of data has been published separately. Repeated within group measures ANOVA is planned to be used to measure effects, and regression used to test for relationships.

The results of this study are expected to contribute to a basis for future prevention of neck pain among skydivers, which is known to have a relation to repeated parachute opening exposure. In work addressing this health problem, our study may create a logical fork with important future implications. From static biomechanics and theoretical calculations, the planned intervention holds the promise of a halved torque in the neck during parachute opening. Though real-world results may not show such an impressive effect, it is important to examine this assumption; if it can be demonstrated to have some merit, further large-scale population studies and implementation would seem warranted, possibly offering an elegant solution to a widespread health problem in this population. If, on the other hand, the planned intervention can be demonstrated to have little or no effect on its biomechanical outcome variables, doubt will be cast upon the conventional wisdom skydiver good advice upon which it is based, shifting future attention more pointedly towards manufacturers of parachute systems.

This study will be conducted in Swedish airspace in cooperation with and under the supervision of the National Safety Officer of the Swedish Parachute Association. All safety resources for sport parachuting available within the Swedish Parachute Association will be employed. This study will be conducted in compliance with the Declaration of Helsinki. All subjects will receive oral and written information about the study, including safety aspects (e.g., agreeing not to perform high-speed landings during the study), and sign a written consent to participate. All subjects will be informed that they can end the study participation at any time.

Being tested
Intervention
Keywords
Aviation, Parachuting
Medical subject headings
Pain, Athletic Injuries, Whiplash Injuries

What participants receive

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

  • InterventionBehavioural

    Standard skydive from 4 000 m above mean sea level (AMSL) following standard safety recommendations and procedures including, if necessary, standard reserve parachute activation procedures. If necessary for safety, participants are asked to immediately leave the study at will. At 1 500 m AMSL, the participant is asked to begin to slow down the fall rate by increasing the body surface area to the relative wind. At no lower than 1 200 m AMSL, the participant is asked to deploy the main parachute. At main parachute deployment, while maintaining a stable body position with shoulders level to the horizon and unaltered heading, the participant is asked to increase the pitch angle of the long body axis attitude, raising the head, shoulders, and upper body up from the flat belly-to-relative-wind plane to a head-high body position, using any free fall technique the participant is comfortable with - as long as there is NO RISK for an unintentional backflip.

Study groups in NCT02625896
Study groupRoleWhat they receive
InterventionExperimentalA sequence of free fall manoeuvres performed using the human body: A free fall velocity reduction prior to main parachute deployment followed by a head high body attitude prior to main parachute extraction.
Receives: Behavioral: Intervention
ControlNo interventionNormal main parachute extraction performed in a manner that is typical for the study participant.

What is being measured

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

  1. Magnitudes of decelerations

    Multidirectional accelerations during ram-air parachute openings expressed in terms of multiples of Earth's gravitational acceleration g using the dimensionless ratio G.

    Measured: 10 seconds

  2. Magnitudes of jerks

    Multidirectional rates of changes of accelerations during ram-air parachute openings expressed in G per second.

    Measured: 10 seconds

Timeline

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

  1. First posted9 Dec 2015 (estimated)
  2. Study start17 Jun 2017
  3. Primary completion14 Oct 2018
  4. Study completion14 Oct 2018

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02625896
Sponsor's protocol ID
CIF FO2015-0005.
Other IDs
CIF D2014-0021
Acronym
ACROPOSE
Status last verified
Oct 2018
First submitted
7 Dec 2015
Last updated
30 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Westman A, Bjornstig U. Injuries in Swedish skydiving. Br J Sports Med. 2007 Jun;41(6):356-64; discussion 364. doi: 10.1136/bjsm.2006.031682. Epub 2007 Jan 15.

    PubMed 17224436
  • Westman A, Sjoling M, Lindberg A, Bjornstig U. The SKYNET data: demography and injury reporting in Swedish skydiving. Accid Anal Prev. 2010 Mar;42(2):778-83. doi: 10.1016/j.aap.2009.11.013. Epub 2009 Dec 31.

    PubMed 20159107
  • Nilsson J, Friden C, Buren V, Westman A, Lindholm P, Ang BO. Musculoskeletal pain and related risks in skydivers: a population-based survey. Aviat Space Environ Med. 2013 Oct;84(10):1034-40. doi: 10.3357/asem.3570.2013.

    PubMed 24261055
  • Gladh K, Ang BO, Lindholm P, Nilsson J, Westman A. Decelerations and muscle responses during parachute opening shock. Aviat Space Environ Med. 2013 Nov;84(11):1205-10. doi: 10.3357/asem.3637.2013.

    PubMed 24279237
  • Lo Martire R, Gladh K, Westman A, Lindholm P, Nilsson J, Ang BO. Neck muscle activity in skydivers during parachute opening shock. Scand J Med Sci Sports. 2016 Mar;26(3):307-16. doi: 10.1111/sms.12428. Epub 2015 Mar 10.

    PubMed 25754941
  • Westman A, Ang BO. Free Fall Acrobatics to Reduce Neck Loads During Parachute Opening Shock: Evaluation of an Intervention (ACROPOSE). BMJ Open Sport Exerc Med. 2016 Apr 26;2(1):e000108. doi: 10.1136/bmjsem-2015-000108. eCollection 2016.

    PubMed 27900175

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Pain and Athletic Injuries, run by Karolinska Institutet at 1 site in Sweden.

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 1 inclusion and 5 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 30 Oct 2018. 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 Sweden. 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?

Magnitudes of decelerations (time frame: 10 seconds). 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 NCT02625896, which also lists 6 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 30 Oct 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in