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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04141488
Other study ID # BitlisErenU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date June 30, 2018

Study information

Verified date October 2019
Source Bitlis Eren University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 30, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers No
Gender All
Age group 25 Years to 68 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
experimantal group
Control Group

Locations

Country Name City State
Turkey Bayram Kapsigay Istanbul Maltepe
Turkey Marmara University Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Bitlis Eren University Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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 SENIAM 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.
Primary 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.
Primary 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 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. Change from baseline grip force score at week 6.
Secondary 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 Change from baseline Pressure Pain Threshold score at week 6.
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