NCT05100394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2021

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
Last Updated

November 8, 2021

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

October 18, 2021

Last Update Submit

October 31, 2021

Conditions

Keywords

Proximal hamstring tendinopathylaser therapyPainMuscle power

Outcome Measures

Primary Outcomes (2)

  • Numerical Pain Rating Scale

    On a scale of 0-10, patients rate their current pain level. Higher scores mean worse outcome.

    3 weeks.

  • Isokinetic peak torque

    Isokinetic muscle power was measured.

    3 weeks.

Study Arms (2)

Experimental Group

EXPERIMENTAL

High Power laser therapy was provided.

Radiation: Laser Therapy

Control Group

ACTIVE COMPARATOR

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

Other: Ultrasound + Moist Heat pack + Exercises

Interventions

Laser TherapyRADIATION

Therapeutic laser therapy was applied.

Experimental Group

Ultrasound therapy, a moist heat pack, and a home exercise program were given.

Control Group

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Athletes
  • pain located deep in the buttock/posterior thigh region
  • tenderness of ischial tuberosity
  • hamstring muscle tightness.

You may not qualify if:

  • Recent trauma to the posterior thigh
  • Musculoskeletal disorder of ipsilateral lower extremity
  • taking pain medication daily
  • hypertension, malignancy, autoimmune disease, phlebitis, blood disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Saud University

Riyadh, 11433, Saudi Arabia

Location

MeSH Terms

Conditions

TendinopathyPain

Interventions

Laser TherapyHigh-Energy Shock WavesExercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, OperativeUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Masood Khan, MPTh

    King Saud University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and outcome assessor was unaware of allocation into experimental or control groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm parallel-groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

October 18, 2021

First Posted

October 29, 2021

Study Start

April 5, 2021

Primary Completion

August 27, 2021

Study Completion

September 23, 2021

Last Updated

November 8, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations