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Effectiveness of Laser Therapy on Proximal Hamstring Tendinopathy

Primary Purpose

Tendinopathy, Lasers

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Laser Therapy
Ultrasound + Moist Heat pack + Exercises
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring Proximal hamstring tendinopathy, laser therapy, Pain, Muscle power

Eligibility Criteria

18 Years - 35 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • King Saud University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

High Power laser therapy was provided.

Conventional physiotherapy was applied including moist heat packs, US, and eccentric hamstring exercises.

Outcomes

Primary Outcome Measures

Numerical Pain Rating Scale
On a scale of 0-10, patients rate their current pain level. Higher scores mean worse outcome.
Isokinetic peak torque
Isokinetic muscle power was measured.

Secondary Outcome Measures

Full Information

First Posted
October 18, 2021
Last Updated
October 31, 2021
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT05100394
Brief Title
Effectiveness of Laser Therapy on Proximal Hamstring Tendinopathy
Official Title
Effectiveness of High Power Laser Therapy on Pain and Isokinetic Power in Athletes With Proximal Hamstring Tendinopathy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 5, 2021 (Actual)
Primary Completion Date
August 27, 2021 (Actual)
Study Completion Date
September 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy, Lasers
Keywords
Proximal hamstring tendinopathy, laser therapy, Pain, Muscle power

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm parallel-groups
Masking
ParticipantOutcomes Assessor
Masking Description
Participants and outcome assessor was unaware of allocation into experimental or control groups.
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
High Power laser therapy was provided.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Conventional physiotherapy was applied including moist heat packs, US, and eccentric hamstring exercises.
Intervention Type
Radiation
Intervention Name(s)
Laser Therapy
Intervention Description
Therapeutic laser therapy was applied.
Intervention Type
Other
Intervention Name(s)
Ultrasound + Moist Heat pack + Exercises
Intervention Description
Ultrasound therapy, a moist heat pack, and a home exercise program were given.
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale
Description
On a scale of 0-10, patients rate their current pain level. Higher scores mean worse outcome.
Time Frame
3 weeks.
Title
Isokinetic peak torque
Description
Isokinetic muscle power was measured.
Time Frame
3 weeks.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masood Khan, MPTh
Organizational Affiliation
King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Saud University
City
Riyadh
ZIP/Postal Code
11433
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Laser Therapy on Proximal Hamstring Tendinopathy

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