NCT05077761

Brief Summary

A total of 154 healthy young individuals will be recruited by purposive sampling method to participate in a randomized, single-blinded, sham-controlled study. Recruited participants will be randomly dividing into two groups, the Active high-intensity laser therapy (a-HILT) group, and the Sham high-intensity laser therapy (s-HILT) group. The treatment duration will be 10 minutes per session on both lower limbs for each day for 3 days/week for 2 weeks. Hamstring muscle length will be assessed at baseline, end of the 2-week post-intervention period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1.6 years

First QC Date

October 1, 2021

Last Update Submit

October 9, 2023

Conditions

Keywords

FlexibilityHamstringLaser therapyYoung adults

Outcome Measures

Primary Outcomes (2)

  • Active Knee Extension Test

    Active knee extension test (AKET) is most reliable method to assess the hamstring tightness.

    Changes will be measured at baseline, end of two week post intervention

  • Sit and toe touch test

    Sit and toe touch test is used to assess the hamstring flexibility

    Changes will be measured at baseline, end of two week post intervention

Study Arms (2)

High-intensity laser therapy

EXPERIMENTAL

77 participants will receive active high-intensity laser therapy interventions on hamstring muscle to improve the flexibility of muscle

Device: Active High-intensity laser therapy

Sham High-intensity laser therapy

SHAM COMPARATOR

77 participants will receive sham high-intensity laser therapy on hamstring muscle

Device: Sham High-intensity laser therapy

Interventions

High-intensity laser therapy will be used in the contact method, with the laser beam irradiated over the hamstring muscle. Dosage and parameters for the laser will be calculated. Parameters- 1. Wavelength- 980 nm 2. Intensity/Power density- 3W/cm2 3. Emission mode- Continuous Emission 4. Energy (Joules)- 490 J 5. Irradiation time- 70 Sec on each point 6. Peak power- 15 Watt 7. Irradiation points- 09

High-intensity laser therapy

Sham High-intensity laser therapy will be used in the contact method, without the laser beam irradiation over the hamstring muscle.

Sham High-intensity laser therapy

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Asymptomatic young adults
  • Both gender
  • Tightness of hamstring muscles

You may not qualify if:

  • Any other musculoskeletal disorder
  • Any disc pathology
  • Any nerve root irritation
  • Any surgical history or trauma
  • Malignancy
  • Pregnancy
  • Sensory dysfunctions
  • Cardiac pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maharishi Markandeshwar (M.M) Hospital, Mullana, Ambala, Haryana

Ambāla, Haryana, 133207, India

Location

Related Publications (6)

  • Cejudo A, Centenera-Centenera JM, Santonja-Medina F. The Potential Role of Hamstring Extensibility on Sagittal Pelvic Tilt, Sagittal Spinal Curves and Recurrent Low Back Pain in Team Sports Players: A Gender Perspective Analysis. Int J Environ Res Public Health. 2021 Aug 16;18(16):8654. doi: 10.3390/ijerph18168654.

    PMID: 34444402BACKGROUND
  • Jozwiak M, Pietrzak S, Tobjasz F. The epidemiology and clinical manifestations of hamstring muscle and plantar foot flexor shortening. Dev Med Child Neurol. 1997 Jul;39(7):481-3. doi: 10.1111/j.1469-8749.1997.tb07468.x.

    PMID: 9285439BACKGROUND
  • Medeiros DM, Aimi M, Vaz MA, Baroni BM. Effects of low-level laser therapy on hamstring strain injury rehabilitation: A randomized controlled trial. Phys Ther Sport. 2020 Mar;42:124-130. doi: 10.1016/j.ptsp.2020.01.006. Epub 2020 Jan 10.

    PMID: 31991284BACKGROUND
  • Dornelles MP, Fritsch CG, Sonda FC, Johnson DS, Leal-Junior ECP, Vaz MA, Baroni BM. Photobiomodulation therapy as a tool to prevent hamstring strain injuries by reducing soccer-induced fatigue on hamstring muscles. Lasers Med Sci. 2019 Aug;34(6):1177-1184. doi: 10.1007/s10103-018-02709-w. Epub 2019 Jan 3.

    PMID: 30607719BACKGROUND
  • Hughes T, Callaghan M. BET 2: LASER THERAPY IN THE TREATMENT OF ACUTE HAMSTRING MUSCLE INJURIES. Emerg Med J. 2017 Apr;34(4):266. doi: 10.1136/emermed-2017-206665.2.

    PMID: 28341795BACKGROUND
  • Ramos GA, Arliani GG, Astur DC, Pochini AC, Ejnisman B, Cohen M. Rehabilitation of hamstring muscle injuries: a literature review. Rev Bras Ortop. 2016 Dec 15;52(1):11-16. doi: 10.1016/j.rboe.2016.12.002. eCollection 2017 Jan-Feb.

    PMID: 28194375BACKGROUND

Study Officials

  • Adarsh K Srivastav, PhD Scholar

    MMIPR, MM(DU)

    PRINCIPAL INVESTIGATOR
  • Asir J Samuel, PhD

    MMIPR, MM(DU)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 1, 2021

First Posted

October 14, 2021

Study Start

January 1, 2022

Primary Completion

August 19, 2023

Study Completion

October 9, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations