Back to resultsExamining The Efficacy Of Scapular Exercises On Pain And Function İn Patients With Lateral Epicondylitis
Primary Purpose
Lateral Epicondylitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
experimantal group
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Lateral Epicondylitis, electromyography, pain, scapula
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Bayram Kapsigay
- Marmara University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimantel Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
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.
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.
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.
Secondary Outcome Measures
Grip Force Assessment
Grip force was made by JAMAR brand dynamometer. The first measurement was performed with the elbow 90o flexed in the sitting position, the forearm in the neutral position, the shoulder adduction, the wrist between 0-30o and arm supported in the chair, the second measurement was repeated averaged five times while the arm was in adduction in the elbow extension, and the mean was recorded in terms of (lbs) -force.
Pressure Pain Threshold Assessment
It is a device used to evaluate pain sensitivity and to determine pressure perception. The pressure pain threshold is defined as the minimum pressure that causes pain or discomfort. In our study, pressure gauge res J Tech Commander Algometer produced by "J Tech Medical" was used to determine the pressure pain threshold. The device is a digital pain threshold meter and consists of a sensor connected to the hard tip with a diameter of 1 cm. The measurement was performed in sitting position, shoulder abduction, elbow, forearm, wrist and hand. Patients were previously told to stop the therapist at the point where the pressure turned into a painful sensation and continued to the limit that the patient could withstand by applying a compressive pressure on the lateral epicondyle
Full Information
NCT ID
NCT04141488
First Posted
October 16, 2019
Last Updated
October 25, 2019
Sponsor
Bitlis Eren University
Collaborators
Marmara University
1. Study Identification
Unique Protocol Identification Number
NCT04141488
Brief Title
Examining The Efficacy Of Scapular Exercises On Pain And Function İn Patients With Lateral Epicondylitis
Official Title
Examining The Efficacy Of Scapular Exercises On Pain, Muscle Activation And Function İn Patients With Lateral Epicondylitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bitlis Eren University
Collaborators
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Thirty patients who participated in the study were randomly divided into two groups. First group (n=15), conventional physiotherapy program and exercise, second group (n=15), in addition to the conventional physiotherapy program and exercises, scapula exercises were applied. Patients were evaluated before and after treatment by VAS, algometer, hand dynamometer, EMG, UEFS, PRTEE and DASH questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
Lateral Epicondylitis, electromyography, pain, scapula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimantel Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
experimantal group
Other Intervention Name(s)
Control Group
Intervention Description
Control Group
Primary Outcome Measure Information:
Title
Pain Severity Assessment
Description
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
Time Frame
Change from baseline pain severity of Lateral Epicondylitis at week 6.
Title
Muscle Activation Assessment
Description
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.
Time Frame
Change from baseline EMG activation of the forearm extensor muscles at week 6.
Title
Functional Level Assessment
Description
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.
Time Frame
Change from baseline functional level score at week 6.
Title
Functionality Assessment
Description
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.
Time Frame
Change from baseline functionality score at week 6.
Secondary Outcome Measure Information:
Title
Grip Force Assessment
Description
Grip force was made by JAMAR brand dynamometer. The first measurement was performed with the elbow 90o flexed in the sitting position, the forearm in the neutral position, the shoulder adduction, the wrist between 0-30o and arm supported in the chair, the second measurement was repeated averaged five times while the arm was in adduction in the elbow extension, and the mean was recorded in terms of (lbs) -force.
Time Frame
Change from baseline grip force score at week 6.
Title
Pressure Pain Threshold Assessment
Description
It is a device used to evaluate pain sensitivity and to determine pressure perception. The pressure pain threshold is defined as the minimum pressure that causes pain or discomfort. In our study, pressure gauge res J Tech Commander Algometer produced by "J Tech Medical" was used to determine the pressure pain threshold. The device is a digital pain threshold meter and consists of a sensor connected to the hard tip with a diameter of 1 cm. The measurement was performed in sitting position, shoulder abduction, elbow, forearm, wrist and hand. Patients were previously told to stop the therapist at the point where the pressure turned into a painful sensation and continued to the limit that the patient could withstand by applying a compressive pressure on the lateral epicondyle
Time Frame
Change from baseline Pressure Pain Threshold score at week 6.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayram Kapsigay, MSc
Organizational Affiliation
Bitlis Eren University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bayram Kapsigay
City
Istanbul
State/Province
Maltepe
ZIP/Postal Code
34000
Country
Turkey
Facility Name
Marmara University
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
12. IPD Sharing Statement
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Examining The Efficacy Of Scapular Exercises On Pain And Function İn Patients With Lateral Epicondylitis
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