Lateral EpicondylitisNCT04141488
Examining The Efficacy Of Scapular Exercises On Pain And Function İn Patients With Lateral Epicondylitis
A study testing experimantal group in people with Lateral Epicondylitis, run by Bitlis Eren University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 25 to 68 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- experimantal group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Bayram Kapsigay
Istanbul, Maltepe, 34000
Marmara University
Istanbul, 34000
About this study
Official title: Examining The Efficacy Of Scapular Exercises On Pain, Muscle Activation And Function İn Patients With Lateral Epicondylitis
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.
Read the 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.
- Conditions
- Lateral Epicondylitis
- Being tested
- experimantal group
- Keywords
- Lateral Epicondylitis, electromyography, pain, scapula
- Medical subject headings
- Tennis Elbow, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimantal groupOther
Also called Control Group
Control Group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: experimantal group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline functionality score at week 6.
Secondary outcomes (2)
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.
Measured: Change from baseline grip force score at week 6.
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
Measured: Change from baseline Pressure Pain Threshold score at week 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 May 2017
- Primary completion30 Apr 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Principal investigator, Bayram Kapşigay, Bitlis Eren University
- Investigators
- Bayram Kapsigay, MSc, Principal investigator, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141488
- Sponsor's protocol ID
- BitlisErenU
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining The Efficacy Of Scapular Exercises On Pain, Muscle Activation And Function İn Patients With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT04141488
- Acronym / sponsor ID
- BitlisErenU
- Conditions
- Lateral Epicondylitis
- Keywords
- Lateral Epicondylitis, electromyography, pain, scapula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Experimantel Group | Experimental | Other: experimantal groupElectrotherapy 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 | Other | Other: experimantal groupElectrotherapy 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. |
Who may qualify
- Ages
- 25 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- People with pacemakers or cardiac arrhythmias
- Tumoral disease
- Pregnant women
- Head and neck, elbow, scapula joint pathologies
- Acute infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimantal groupAlso: Control GroupControl Group | Other | Control Group, Experimantel Group |
Primary outcome
Pain Severity Assessment
Time frame: Change from baseline pain severity of Lateral Epicondylitis at week 6.
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
Time frame: Change from baseline EMG activation of the forearm extensor muscles at week 6.
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
Time frame: Change from baseline functional level score at week 6.
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
Time frame: Change from baseline functionality score at week 6.
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.
2 secondary outcomes
Grip Force Assessment
Time frame: Change from baseline grip force score at week 6.
Pressure Pain Threshold Assessment
Time frame: Change from baseline Pressure Pain Threshold score at week 6.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
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Metabolic and Inflammatory Indices in Lateral Epicondylitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayram Kapsigay, MSc principal investigator
Bitlis Eren University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimantal group in people with Lateral Epicondylitis, run by Bitlis Eren University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity Assessment (time frame: Change from baseline pain severity of Lateral Epicondylitis at week 6.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2019.