NCT06568796

Brief Summary

To compare the effects of Trigger Point Ischaemic Compression Massage (TPICM) and Focused Extracarporeal Shock Wave Therapy (focused ESWT) on pain level, muscle strength, Joint range of motion, functionality and quality of life in patients with lateral epicondylitis (LE) in a randomised controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

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

June 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 23, 2024

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

August 12, 2024

Last Update Submit

August 22, 2024

Conditions

Keywords

lateral epicondylitistrigger points ıschemıc compressıon massagefocus eswt

Outcome Measures

Primary Outcomes (6)

  • grip strenght asessment with jamar hand dynamometer

    It will be grip strength assessment with jamar hand dynamometer

    baseline-up to 4 weeks

  • muscle strenght asessment with isocinetic system

    It will be elbow flexor and extansor muscle strength asessment with isocinetic system

    baseline-up to 4 weeks

  • range of motion asessment with universal goniometer

    It will be elbow range of motion asessment with universal goniometer

    baseline-up to 4 weeks

  • assessment of quality of life with quality of life questionnaire

    It will be asessment of quality of life with life questionnaire

    baseline-up to 4 weeks

  • pain level asessment with visual analog scale

    It will be asessment of pain level with visual analog scale

    baseline-up to 4 weeks

  • assessment of functionality with functionality questionnaire

    It will be asessment of functionality with functionality questionnaire

    baseline-up to 4 weeks

Study Arms (3)

Focused Ekstracorporeal Shoch Wave Theraphy and Exercise

EXPERIMENTAL

Individuals will be administered focused ekstracorporeal shoch wave theraphy 1 day a week for 4 weeks. Individuals will exercise every day

Other: randomize controlled study

Trigger Point Ischemic Compression Massage and Exercise

EXPERIMENTAL

Individuals will receive trigger point ischemic compression massage 2 days a week for 4 weeks. Individuals will exercise every day

Other: randomize controlled study

Exercise

NO INTERVENTION

Individuals will only exercise every day.

Interventions

eswt treatment

Focused Ekstracorporeal Shoch Wave Theraphy and ExerciseTrigger Point Ischemic Compression Massage and Exercise

Eligibility Criteria

Age18 Years - 60 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female individuals between the ages of 18-60
  • being diagnosed with lateral epicondylitis
  • volunteering to participate in the study

You may not qualify if:

  • non-cooperation
  • presence of systemic and metabolic diseases
  • malignancy, osteoporosis, fracture, blood clotting disorder, pacemaker, infection
  • pregnancy
  • utilization of another treatment for lateral epicondylitis during the study period
  • previous invasive treatment with steroids for lateral epicondylitis
  • any treatment for lateral epicondylitis in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gülhane Eğitim ve Araştırma Hastanesi

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 12, 2024

First Posted

August 23, 2024

Study Start

June 1, 2023

Primary Completion

April 1, 2024

Study Completion

June 1, 2024

Last Updated

August 26, 2024

Record last verified: 2024-08

Locations