NCT06811883

Brief Summary

In athletics, in the sprint and hurdles disciplines, muscle injuries account for a significant proportion of injuries. The hamstrings are particularly vulnerable, accounting for between 12% and 26% of all injuries in these sports. A single-blind study was conducted on 20 hurdler patients with the intention of assessing hip mobility, hamstring flexibility and performance. To collect this data, the research team will conduct examinations and interviews with the athletes in two groups: an experimental group using LightBack and a placebo group.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

January 31, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 31, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 6, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

January 31, 2025

Last Update Submit

February 5, 2025

Conditions

Injury;Sports

Keywords

range of motionpreventionPhysiotherapyathletics

Outcome Measures

Primary Outcomes (1)

  • hip mobility

    measurement of hip mobility measured by goniometry

    5 weeks

Secondary Outcomes (2)

  • hamstring flexibility

    5 weeks

  • performance

    5 weeks

Study Arms (2)

LIGHTBACK Gropu

EXPERIMENTAL

This group will perform a standard 20-minute warm-up, and in addition to their usual warm-up, the LIGHTBACK protocol is included.

Device: LIGHTBACK

Placebo Group

PLACEBO COMPARATOR

This group will perform a standard 20-minute warm-up, but the LIGHTBACK protocol is not included and a similar placebo is used.

Device: Placebo

Interventions

LIGHTBACKDEVICE

This group will perform a standard 20-minute warm-up, and the LIGHTBACK protocol is also included.

LIGHTBACK Gropu
PlaceboDEVICE

This group will perform a standard 20-minute warm-up, but the LIGHTBACK protocol is not included and a similar placebo is used.

Placebo Group

Eligibility Criteria

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

You may qualify if:

  • Sprinters and hurdlers aged 18 to 30 years.
  • No history of recent (less than 6 months) hamstring or hip injury.
  • Signed informed consent.

You may not qualify if:

  • Cruciate or hamstring tears less than 6 months old;
  • Hip and back surgery less than 3 months old;
  • Chronic or acute back problems;
  • Pregnancy;
  • Osteoporosis
  • Tumours, bone cancer of the hip and pelvis;
  • Direct trauma to the back of the thigh less than 6 months old.
  • Orthopaedic or neurological pathologies affecting mobility or muscle activation.
  • Participation in another specific training protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Pontificia de Salamanca

Salamanca, 27005, Spain

RECRUITING

Related Publications (6)

  • Edouard P, Branco P, Alonso JM. Muscle injury is the principal injury type and hamstring muscle injury is the first injury diagnosis during top-level international athletics championships between 2007 and 2015. Br J Sports Med. 2016 May;50(10):619-30. doi: 10.1136/bjsports-2015-095559. Epub 2016 Feb 17.

    PMID: 26887415RESULT

  • Askling CM, Tengvar M, Thorstensson A. Acute hamstring injuries in Swedish elite football: a prospective randomised controlled clinical trial comparing two rehabilitation protocols. Br J Sports Med. 2013 Oct;47(15):953-9. doi: 10.1136/bjsports-2013-092165. Epub 2013 Mar 27.

    PMID: 23536466RESULT

  • Edouard P, Lahti J, Fleres L, Ahtiainen J, Ulvila JJ, Lehtinen T, Virtanen N, Taipale T, Bellver M, Peltonen V, Thibault M, Huuhka T, Toivonen RM, Morin JB, Mendiguchia J. A musculoskeletal multifactorial individualised programme for hamstring muscle injury risk reduction in professional football: results of a prospective cohort study. BMJ Open Sport Exerc Med. 2024 Feb 8;10(1):e001866. doi: 10.1136/bmjsem-2023-001866. eCollection 2024.

    PMID: 38347859RESULT

  • Edouard P, Mendiguchia J, Lahti J, Arnal PJ, Gimenez P, Jimenez-Reyes P, Brughelli M, Samozino P, Morin JB. Sprint Acceleration Mechanics in Fatigue Conditions: Compensatory Role of Gluteal Muscles in Horizontal Force Production and Potential Protection of Hamstring Muscles. Front Physiol. 2018 Nov 30;9:1706. doi: 10.3389/fphys.2018.01706. eCollection 2018.

    PMID: 30555346RESULT

  • Bissas A, Paradisis GP, Hanley B, Merlino S, Walker J. Kinematic and Temporal Differences Between World-Class Men's and Women's Hurdling Techniques. Front Sports Act Living. 2022 Apr 29;4:873547. doi: 10.3389/fspor.2022.873547. eCollection 2022.

    PMID: 35571744RESULT

  • Nagahara R, Wakamiya M, Shinohara Y, Nagano A. Ground reaction forces during sprint hurdles. J Sports Sci. 2021 Dec;39(23):2706-2715. doi: 10.1080/02640414.2021.1954325. Epub 2021 Jul 27.

    PMID: 34313537RESULT

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

JORGE Velázquez Saornil, PhD.

CONTACT

655909940jvelazquezsa@upsa.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Placebo Group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: LIGHTBACK Group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD.

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 6, 2025

Study Start

January 31, 2025

Primary Completion

March 31, 2025

Study Completion

June 30, 2025

Last Updated

February 6, 2025

Record last verified: 2025-01

Locations

ES(1)