NCT04141488

Brief Summary

We aimed to investigate the effect of scapular exercises on pain and functioning in patients with lateral epicondylitis to achieve a more accurate result by using little-used EMG between scapula and elbow muscles in the literature besides ongoing classical measurements and evaluations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

2 active sites

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

May 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

12 months

First QC Date

October 16, 2019

Last Update Submit

October 25, 2019

Conditions

Keywords

Lateral Epicondylitiselectromyographypainscapula

Outcome Measures

Primary Outcomes (4)

  • Pain Severity Assessment

    In order to evaluate the general pain severity of the patients, Visual Analog Scale (VAS), which is the Visual Pain Scale of Turkish, was used. Patients were asked to mark their general pain separately on a 10 cm scale. According to this, "0" indicates that there is no pain, and "10" indicates the most severe pain. The distance between the marked point and the beginning of the line was recorded in centimeters

    Change from baseline pain severity of Lateral Epicondylitis at week 6.

  • Muscle Activation Assessment

    In order to record the EMG signals of the ECRB muscle, the bipolar Ag / AgCl was adhered to the designated area at a distance of 1 cm between the centers of the superficial electrodes according to SENİAM criteria and the reference electrode was placed in the farthest region. Before the electrodes were bonded, the skin surface was shaved with a razor blade and cleaned with isopropyl alcohol to get a better signal. The measurements were made simultaneously in grip position with the automatically tuned EMG biofeedback.

    Change from baseline EMG activation of the forearm extensor muscles at week 6.

  • Functional Level Assessment

    In order to determine the level of functional, "Arm, Shoulder and Hand Problems Questionnaire (DASH-T)" was used. The scale consists of three parts. The first 21 questions assess the patient's difficulty during daily life activities, 5 questions assess symptoms (pain, pain due to activity, tingling, stiffness, weakness), and the remaining 4 questions assess social function, work, sleep and self-confidence. Each question is scored from 1 to 5 and subtracted from 1, multiplied by 25. A high score indicates a bad apology.

    Change from baseline functional level score at week 6.

  • Functionality Assessment

    In order to measure yhe functionality Upper Extremity Functionality Indeks (UEFI) was used. It consists of 8 questions. These include questions such as opening jars, driving more than 30 minutes, sleeping, writing, grasping small objects with their fingers, taking jugs from the refrigerator, opening doors and washing dishes. A visual scale is asked for each question. 1 shows that there is no pain and 10 indicates that the pain is the most severe. The total score is between 8-80.

    Change from baseline functionality score at week 6.

Secondary Outcomes (2)

  • Grip Force Assessment

    Change from baseline grip force score at week 6.

  • Pressure Pain Threshold Assessment

    Change from baseline Pressure Pain Threshold score at week 6.

Study Arms (2)

Experimantel Group

EXPERIMENTAL

Electrotherapy program in our study 20 minutes, Hot-pack (HP) 20 minutes, 60-120 Hz frequency range 50-100 millisecond pulse time conventional TENS (Transcutaneous Electrical Nerve Stimulation) and 5 minutes 1.5 watt / cm2 treatment dosage 1 MHz ' ultrasound (US) treatment was applied. Exercise program; Eccentric and concentric strengthening and stretching of ECBR and ECBL muscles, terminal elbow flexion and extension, forearm pronation and supination exercises were given. Electrotherapy was given as 15 sessions for 6 weeks, 2 or 3 days a week, 1 session per day, and 30 sessions for 6 weeks, 5 days per week. Fifteen of these exercise sessions were supervised by the physiotherapist in the hospital and the remaining 15 patients did not come to the clinic on their own. The experimantel group was given strengthening exercises of the upper trapezoidal, middle trapezoidal and serratus anterior muscles with extra scapula muscles.

Other: experimantal group

Control Group

OTHER

Electrotherapy program in our study 20 minutes, Hot-pack (HP) 20 minutes, 60-120 Hz frequency range 50-100 millisecond pulse time conventional TENS (Transcutaneous Electrical Nerve Stimulation) and 5 minutes 1.5 watt / cm2 treatment dosage 1 MHz ' ultrasound (US) treatment was applied. Exercise program; Eccentric and concentric strengthening and stretching of ECBR and ECBL muscles, terminal elbow flexion and extension, forearm pronation and supination exercises were given. Electrotherapy was given as 15 sessions for 6 weeks, 2 or 3 days a week, 1 session per day, and 30 sessions for 6 weeks, 5 days per week. Fifteen of these exercise sessions were supervised by the physiotherapist in the hospital and the remaining 15 patients did not come to the clinic on their own.

Other: experimantal group

Interventions

Control Group

Also known as: Control Group
Control GroupExperimantel Group

Eligibility Criteria

Age25 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cases diagnosed with lateral epicondylitis by the physician and decided to receive conservative treatment
  • Not receiving NSAID or other medical treatment
  • Untreated Lateral Epicondylitis for the last 6 months
  • Cases with age range 18-75
  • Patients with pain and tenderness for at least 3 months

You may not qualify if:

  • People with pacemakers or cardiac arrhythmias
  • Tumoral disease
  • Pregnant women
  • Head and neck, elbow, scapula joint pathologies
  • Acute infection
  • Nerve or nerve root compression
  • Other musculoskeletal problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bayram Kapsigay

Istanbul, Maltepe, 34000, Turkey (Türkiye)

Location

Marmara University

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis ElbowPain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Bayram Kapsigay, MSc

    Bitlis Eren University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 28, 2019

Study Start

May 1, 2017

Primary Completion

April 30, 2018

Study Completion

June 30, 2018

Last Updated

October 28, 2019

Record last verified: 2019-10

Locations