- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05100394
Effectiveness of Laser Therapy on Proximal Hamstring Tendinopathy
October 31, 2021 updated by: Masood Khan, King Saud University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Riyadh, Saudi Arabia, 11433
- King Saud University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Athletes
- pain located deep in the buttock/posterior thigh region
- tenderness of ischial tuberosity
- hamstring muscle tightness.
Exclusion Criteria:
- Recent trauma to the posterior thigh
- Musculoskeletal disorder of ipsilateral lower extremity
- taking pain medication daily
- hypertension, malignancy, autoimmune disease, phlebitis, blood disorder.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
High Power laser therapy was provided.
|
Therapeutic laser therapy was applied.
|
|
Active Comparator: Control Group
Conventional physiotherapy was applied including moist heat packs, US, and eccentric hamstring exercises.
|
Ultrasound therapy, a moist heat pack, and a home exercise program were given.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 weeks.
|
|
Isokinetic peak torque
Time Frame: 3 weeks.
|
Isokinetic muscle power was measured.
|
3 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 5, 2021
Primary Completion (Actual)
August 27, 2021
Study Completion (Actual)
September 23, 2021
Study Registration Dates
First Submitted
October 18, 2021
First Submitted That Met QC Criteria
October 18, 2021
First Posted (Actual)
October 29, 2021
Study Record Updates
Last Update Posted (Actual)
November 8, 2021
Last Update Submitted That Met QC Criteria
October 31, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRC-2021-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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