Muscle TightnessNCT05077761
Laser Therapy on Hamstring Muscle Among Young Adults
A study testing Active High-intensity laser therapy in people with Muscle Tightness, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Tightness
- What is being tested?
- Active High-intensity laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2022to 9 Oct 2023
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Asymptomatic young adults
- Both gender
- Tightness of hamstring muscles
Who cannot join
- Any other musculoskeletal disorder
- Any disc pathology
- Any nerve root irritation
- Any surgical history or trauma
- Malignancy
- Pregnancy
- Sensory dysfunctions
- Cardiac pacemaker
Trial locations and contacts
1 site in 1 country.
India1 site
Maharishi Markandeshwar (M.M) Hospital, Mullana, Ambala, Haryana
Ambāla, Haryana, 133207
About this study
Official title: High-intensity Laser Therapy on Hamstring Muscle Length Among Young Adults
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.
- Conditions
- Muscle Tightness
- Being tested
- Active High-intensity laser therapy, Sham High-intensity laser therapy
- Keywords
- Flexibility, Hamstring, Laser therapy, Young adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active High-intensity laser therapyDevice
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 therapyDevice
Sham High-intensity laser therapy will be used in the contact method, without the laser beam irradiation over the hamstring muscle.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity laser therapy | Experimental | 77 participants will receive active high-intensity laser therapy interventions on hamstring muscle to improve the flexibility of muscle Receives: 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 Receives: Device: Sham High-intensity laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Knee Extension Test
Active knee extension test (AKET) is most reliable method to assess the hamstring tightness.
Measured: 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
Measured: Changes will be measured at baseline, end of two week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Jan 2022
- Primary completion19 Aug 2023
- Study completion9 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Muscle TightnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Adarsh K Srivastav, PhD Scholar, Principal investigator, MMIPR, MM(DU)Asir J Samuel, PhD, Study director, MMIPR, MM(DU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077761
- Sponsor's protocol ID
- U1111-1269-9595
- Status last verified
- Oct 2023
- First submitted
- 1 Oct 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34444402Jozwiak 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.
PubMed 9285439Medeiros 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.
PubMed 31991284Dornelles 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.
PubMed 30607719Hughes 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.
PubMed 28341795Ramos 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.
PubMed 28194375
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Laser Therapy on Hamstring Muscle Length Among Young Adults
- ClinicalTrials.gov ID
- NCT05077761
- Acronym / sponsor ID
- U1111-1269-9595
- Conditions
- Muscle Tightness
- Keywords
- Flexibility, Hamstring, Laser therapy, Young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 19 Aug 2023 (actual)
- Study completion
- 9 Oct 2023 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity laser therapy | Experimental | Device: Active High-intensity laser therapy77 participants will receive active high-intensity laser therapy interventions on hamstring muscle to improve the flexibility of muscle |
| Sham High-intensity laser therapy | Sham comparator | Device: Sham High-intensity laser therapy77 participants will receive sham high-intensity laser therapy on hamstring muscle |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Asymptomatic young adults
- Both gender
- Tightness of hamstring muscles
Key exclusion criteria (8 listed)
- Any other musculoskeletal disorder
- Any disc pathology
- Any nerve root irritation
- Any surgical history or trauma
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active High-intensity laser therapyHigh-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 | Device | High-intensity laser therapy |
| Sham High-intensity laser therapySham High-intensity laser therapy will be used in the contact method, without the laser beam irradiation over the hamstring muscle. | Device | Sham High-intensity laser therapy |
Primary outcome
Active Knee Extension Test
Time frame: Changes will be measured at baseline, end of two week post intervention
Active knee extension test (AKET) is most reliable method to assess the hamstring tightness.
Sit and toe touch test
Time frame: Changes will be measured at baseline, end of two week post intervention
Sit and toe touch test is used to assess the hamstring flexibility
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Background: PubMed 34444402Cejudo 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.
- Background: PubMed 9285439Jozwiak 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.
- Background: PubMed 31991284Medeiros 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.
- Background: PubMed 30607719Dornelles 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.
- Background: PubMed 28341795Hughes 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.
- Background: PubMed 28194375Ramos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adarsh K Srivastav, PhD Scholar principal investigator
MMIPR, MM(DU)
Asir J Samuel, PhD study director
MMIPR, MM(DU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active High-intensity laser therapy in people with Muscle Tightness, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
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 3 inclusion and 8 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 10 Oct 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 India. 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. Some participants in this study may receive a placebo. 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?
Active Knee Extension Test (time frame: Changes will be measured at baseline, end of two week post intervention). 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 NCT05077761, 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 10 Oct 2023.