TendinopathyNCT05100394
Effectiveness of Laser Therapy on Proximal Hamstring Tendinopathy
A study testing Laser Therapy and Ultrasound + Moist Heat pack + Exercises in people with Tendinopathy and Lasers, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Proximal hamstring tendinopathy (PHT) is tendinopathy of the semimembranosus and/or biceps femoris/semitendinosus complex. Previous studies have shown the efficacy of laser therapy in the treatment of tendinopathy. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men only
- Conditions the study is for
- Tendinopathy, Lasers
- What is being tested?
- Laser Therapy and Ultrasound + Moist Heat pack + Exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 5 Apr 2021to 23 Sep 2021
- 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 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Athletes
- pain located deep in the buttock/posterior thigh region
- tenderness of ischial tuberosity
- hamstring muscle tightness.
Who cannot join
- Recent trauma to the posterior thigh
- Musculoskeletal disorder of ipsilateral lower extremity
- taking pain medication daily
- hypertension, malignancy, autoimmune disease, phlebitis, blood disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of High Power Laser Therapy on Pain and Isokinetic Power in Athletes With Proximal Hamstring Tendinopathy: a Randomized Controlled Trial
Proximal hamstring tendinopathy (PHT) is tendinopathy of the semimembranosus and/or biceps femoris/semitendinosus complex. Previous studies have shown the efficacy of laser therapy in the treatment of tendinopathy. To the best of the investigator's knowledge, no study has compared the effects of high-power LASER therapy with conventional physiotherapy programs in proximal hamstring tendinopathy patients. Therefore, this study aimed to assess the effects of high-power laser therapy on pain and muscle power in proximal hamstring tendinopathy patients.
Read the detailed description
2 arms comparative pretest-posttest experimental research design with random allocation of subjects into groups (experimental and control group) using the lottery method. A total of thirty-six participants aged between 18-35 (mean age) years, were recruited in the present study. The selected participants were randomly allocated into experimental and control groups using the lottery method and website randomization.com with eighteen participants in each group. The participants and outcome assessor were kept blinded to the allocation. In the experimental group, the high-power laser was given whereas in the control group conventional physiotherapy treatment was given for 4 weeks. Conventional physiotherapy treatment included the US, moist heat pack, and home exercises. Home exercises include nordic hamstring exercises - 2 sets of 5 repetitions, 3 days/week for 3 weeks.
- Conditions
- Tendinopathy, Lasers
- Being tested
- Laser Therapy, Ultrasound + Moist Heat pack + Exercises
- Keywords
- Proximal hamstring tendinopathy, laser therapy, Pain, Muscle power
- Medical subject headings
- Tendinopathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser TherapyRadiation
Therapeutic laser therapy was applied.
Ultrasound + Moist Heat pack + ExercisesOther
Ultrasound therapy, a moist heat pack, and a home exercise program were given.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | High Power laser therapy was provided. Receives: Radiation: Laser Therapy |
| Control Group | Active comparator | Conventional physiotherapy was applied including moist heat packs, US, and eccentric hamstring exercises. Receives: Other: Ultrasound + Moist Heat pack + Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale
On a scale of 0-10, patients rate their current pain level. Higher scores mean worse outcome.
Measured: 3 weeks.
Isokinetic peak torque
Isokinetic muscle power was measured.
Measured: 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start5 Apr 2021
- Primary completion27 Aug 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies 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
- Model description
- Two-arm parallel-groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masood Khan, King Saud University
- Investigators
- Masood Khan, MPTh, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100394
- Sponsor's protocol ID
- RRC-2021-07
- Status last verified
- Oct 2021
- First submitted
- 18 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High Power Laser Therapy on Pain and Isokinetic Power in Athletes With Proximal Hamstring Tendinopathy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05100394
- Acronym / sponsor ID
- RRC-2021-07
- Conditions
- Tendinopathy, Lasers
- Keywords
- Proximal hamstring tendinopathy, laser therapy, Pain, Muscle power
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 29 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.
Proximal hamstring tendinopathy (PHT) is tendinopathy of the semimembranosus and/or biceps femoris/semitendinosus complex. Previous studies have shown the efficacy of laser therapy in the treatment of tendinopathy. To the best of the investigator's knowledge, no study has compared the effects of high-power LASER therapy with conventional physiotherapy programs in proximal hamstring tendinopathy patients. Therefore, this study aimed to assess the effects of high-power laser therapy on pain and muscle power in proximal hamstring tendinopathy patients.
Detailed description
2 arms comparative pretest-posttest experimental research design with random allocation of subjects into groups (experimental and control group) using the lottery method. A total of thirty-six participants aged between 18-35 (mean age) years, were recruited in the present study. The selected participants were randomly allocated into experimental and control groups using the lottery method and website randomization.com with eighteen participants in each group. The participants and outcome assessor were kept blinded to the allocation. In the experimental group, the high-power laser was given whereas in the control group conventional physiotherapy treatment was given for 4 weeks. Conventional physiotherapy treatment included the US, moist heat pack, and home exercises. Home exercises include nordic hamstring exercises - 2 sets of 5 repetitions, 3 days/week for 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel-groups
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Radiation: Laser TherapyHigh Power laser therapy was provided. |
| Control Group | Active comparator | Other: Ultrasound + Moist Heat pack + ExercisesConventional physiotherapy was applied including moist heat packs, US, and eccentric hamstring exercises. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Athletes
- pain located deep in the buttock/posterior thigh region
- tenderness of ischial tuberosity
- hamstring muscle tightness.
Key exclusion criteria (4 listed)
- Recent trauma to the posterior thigh
- Musculoskeletal disorder of ipsilateral lower extremity
- taking pain medication daily
- hypertension, malignancy, autoimmune disease, phlebitis, blood disorder.
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 |
|---|---|---|
| Laser TherapyTherapeutic laser therapy was applied. | Radiation | Experimental Group |
| Ultrasound + Moist Heat pack + ExercisesUltrasound therapy, a moist heat pack, and a home exercise program were given. | Other | Control Group |
Primary outcome
Numerical Pain Rating Scale
Time frame: 3 weeks.
On a scale of 0-10, patients rate their current pain level. Higher scores mean worse outcome.
Isokinetic peak torque
Time frame: 3 weeks.
Isokinetic muscle power was measured.
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 8 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Tendinopathy
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High and Low Level Laser Therapy in De Quervain's Tenosynovitis
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High-intensity Laser Therapy Versus Extracorporeal Shock Wave on Tendon Thickness and Occupation Ratio In Patients With Chronic Supraspinatus Tendinopathy
Supraspinatus Tendinopathy
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Vibratory Anesthesia on Pain Following Corticosteroid Injections
Bilateral Arthritis of Wrist, Tendinopathy
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Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders
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Not yet recruitingObservational study
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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.
Masood Khan, MPTh principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Therapy and Ultrasound + Moist Heat pack + Exercises in people with Tendinopathy and Lasers, run by King Saud University at 1 site in Saudi Arabia.
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 4 inclusion and 4 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 8 Nov 2021. 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 Saudi Arabia. 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?
Numerical Pain Rating Scale (time frame: 3 weeks.). 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?
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 8 Nov 2021.