NCT06301152

Brief Summary

Objectives: This study aims to evaluate and compare the short-term efficacy of high-intensity laser therapy (HILT) and extra corporeal shock wave therapy(ESWT) on pain, sensitivity, handgrip strength, and functions in the treatment of lateral epicondylitis (LE). Material and methods: Forty five participants (age range, 18 to 65 years) with unilateral elbow pain were randomized into two groups. HILT group (n = 22) and the ESWT group (n = 23). The HILT and ESWT were administered three times a week for three weeks, and each treatment was combined with exercises. All patients in both groups were evaluated with ultrasonography for common extensor tendon(CET) thickness. A visual analog scale (VAS), Quick Disabilities of the Arm, Shoulder, and Hand (QDASH), and hand grip strength test were used to evaluate the patients before, one, and six weeks after treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

1 month

First QC Date

February 21, 2024

Last Update Submit

March 7, 2024

Conditions

Keywords

Lateral EpicondylitisHigh Intensive Laser TherapyExtracorporeal Shock Wave TherapyMusculoskeletal ultrasound

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale

    score 0-10, 0 minimum value, mean is no pain, score 10 is maximum value, pain is very severe

    Baseline, 1 week and 6 weeks

Secondary Outcomes (3)

  • Quick Disability Arm, Shoulder and Hand questionary,

    Baseline, 1 week and 6 weeks

  • hand grip strength

    Baseline, 1 week and 6 weeks

  • musculoskeletal ultrasonography

    Baseline, 1 week and 6 weeks

Study Arms (2)

high intensive laser

EXPERIMENTAL

high-intensity laser was applied 3 times in a week, for three weeks, total of 9 sessions

Device: high intensive laser

extracorporeal shock wave therapy

EXPERIMENTAL

extracorporeal shock wave therapy was applied once a week, for three weeks total of 3 sessions

Device: extracorporeal shock wave therapy

Interventions

high-intensity laser ,three times in a week, for three weeks, 9 session

high intensive laser

extracorporeal shock wave therapy, once a week, for three weeks ,3 times,

extracorporeal shock wave therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Lateral epicondylitis
  • Age \>18

You may not qualify if:

  • Operation history about elbow
  • Received physical therapy, or had a steroid injection to the elbow in the three months
  • Cervical radiculopathy,
  • Elbow deformities,
  • Fibromyalgia syndrome,
  • Carpal tunnel syndrome,
  • Neurological impairments in the upper extremity,
  • Chronic inflammatory conditions,
  • Hemophilia,
  • Pregnant,
  • History of malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emine Esra Bilir

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two different treatment modalities were applied in two groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2024

First Posted

March 8, 2024

Study Start

September 1, 2022

Primary Completion

October 1, 2022

Study Completion

May 30, 2023

Last Updated

March 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations