NCT05683275

Brief Summary

Pain, decreased grip strength, and loss of function are observed in individuals with lateral epicondylitis. The aim of this study is to investigate the effects of ESWT and IASTM applications on pain, grip strength and function in individuals with lateral epicondylitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 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

First Submitted

Initial submission to the registry

December 28, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

December 28, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2023

Completed
Last Updated

March 14, 2023

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

December 28, 2022

Last Update Submit

March 13, 2023

Conditions

Keywords

Lateral epicondylitispainfunctiongrip strength

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Pain assessed by Visual Analog Scale.

    Pain will be evaluated with Visual Analog Scale. 0 means no pain, 10 means unbearable pain.

    Baseline, 4 weeks

Secondary Outcomes (2)

  • Grip strength

    Baseline, 4 weeks

  • Function assessed by Patient-rated Forearm Evaluation Questionnaire

    Baseline, 4 weeks

Study Arms (3)

IASTM

EXPERIMENTAL

In addition to the home exercise program application, IASTM application will be made for 4 weeks. IASTM will be applied to the affected extremity twice a week for 4 weeks, in total 8 sessions. Participants will be asked to sit comfortably in a chair with back support. IASTM will be applied to the wrist extensor muscles of the participants for 90 seconds in the position where the muscle is tense, with a frequency of 60 beats per minute (Cheatham et al., 2019). The instruments will be applied to the soft tissue at 30º-60º angles, using vaseline as an intermediate, with a multidirectional "stroking" movement.

Other: IASTM

ESWT

EXPERIMENTAL

ESWT will be applied to the affected elbow two days a week for 4 weeks, a total of 8 sessions, each session 2000 shock 10 Hz frequency, 2.5 bar intensity point and circumferential application. Ultrasound gel will be used as an intermediate in the application. No anesthetic substance will be used before and after the application. Cold applications will be recommended for those who have pain after the application.

Other: ESWT

Home Exercise

EXPERIMENTAL

Static stretching and eccentric strengthening exercises specific to the forearm muscles will be taught and they will be asked to perform 2 sets (morning-lunch-evening) 10 repetitions per day, 5 days a week, for 4 weeks. For strengthening exercises, all patients will be asked to use green (medium resistance) elastic bands, hold them in a tense position for 10 seconds, let them back passively, and rest for 1 minute between sets. In the stretching exercise, they will be asked to stay in the most tense position for 30-45 seconds and rest for 30 seconds between stretching. In case of a painful situation, they will be asked to be informed about their information.

Other: Home Exercise

Interventions

IASTMOTHER

IASTM will be applied to the affected extremity twice a week for 4 weeks, in total 8 sessions. Participants will be asked to sit comfortably in a chair with back support. IASTM will be applied to the wrist extensor muscles of the participants for 90 seconds in the position where the muscle is tense, with a frequency of 60 beats per minute.

IASTM
ESWTOTHER

ESWT will be applied to the affected elbow two days a week for 4 weeks, a total of 8 sessions, each session 2000 shock 10 Hz frequency, 2.5 bar intensity point and circumferential application.

ESWT

Special static stretching and eccentric strengthening exercises for the forearm muscles will be taught and they will be asked to perform 2 sets (morning-lunch-evening) 10 repetitions per day, 5 days a week, for 4 weeks.

Home Exercise

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • being diagnosed with chronic LET by a physician
  • visual analog scale (VAS) pain score ≥ 3

You may not qualify if:

  • any accompanying pathology in the wrist and forearm, such as a fracture or dislocation of the elbow;
  • treatment with corticosteroid injections in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, Karatay, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis ElbowPain

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2022

First Posted

January 13, 2023

Study Start

December 28, 2022

Primary Completion

March 7, 2023

Study Completion

March 7, 2023

Last Updated

March 14, 2023

Record last verified: 2022-12

Locations