Examining The Efficacy Of Scapular Exercises On Pain And Function İn Patients With Lateral Epicondylitis
1 other identifier
interventional
30
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2017
2 active sites
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedFirst Submitted
Initial submission to the registry
October 16, 2019
CompletedFirst Posted
Study publicly available on registry
October 28, 2019
CompletedOctober 28, 2019
October 1, 2019
12 months
October 16, 2019
October 25, 2019
Conditions
Keywords
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
EXPERIMENTALElectrotherapy 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.
Control Group
OTHERElectrotherapy 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.
Interventions
Eligibility Criteria
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
- Bitlis Eren Universitylead
- Marmara Universitycollaborator
Study Sites (2)
Bayram Kapsigay
Istanbul, Maltepe, 34000, Turkey (Türkiye)
Marmara University
Istanbul, 34000, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bayram Kapsigay, MSc
Bitlis Eren University
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
- 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