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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05077761
Other study ID # U1111-1269-9595
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date October 9, 2023

Study information

Verified date October 2023
Source Maharishi Markendeswar University (Deemed to be University)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date October 9, 2023
Est. primary completion date August 19, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Asymptomatic young adults - Both gender - Tightness of hamstring muscles Exclusion Criteria: - Any other musculoskeletal disorder - Any disc pathology - Any nerve root irritation - Any surgical history or trauma - Malignancy - Pregnancy - Sensory dysfunctions - Cardiac pacemaker

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Active High-intensity laser therapy
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- Wavelength- 980 nm Intensity/Power density- 3W/cm2 Emission mode- Continuous Emission Energy (Joules)- 490 J Irradiation time- 70 Sec on each point Peak power- 15 Watt Irradiation points- 09
Sham 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.

Locations

Country Name City State
India Maharishi Markandeshwar (M.M) Hospital, Mullana, Ambala, Haryana Ambala Haryana

Sponsors (1)

Lead Sponsor Collaborator
Maharishi Markendeswar University (Deemed to be University)

Country where clinical trial is conducted

India, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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