Lateral EpicondylitisNCT05823233
Effect of Eccentric Stretching in Patients With Lateral Epicondylitis
A study testing Cold application+Deep friction+Home exercise+Eccentric stretching and Cold application+Deep friction+Home exercise in people with Lateral Epicondylitis, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Lateral Epicondylitis; is a disease characterized by insidious onset pain in the lateral elbow of the forearm, which radiates to the distal part of the forearm and increases with grip and wrist extension. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Cold application+Deep friction+Home exercise+Eccentric stretching and Cold application+Deep friction+Home exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 30 Jun 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18 - 65
- Having been diagnosed with Lateral Epicondylitis,
- Pain localized in the elbow for more than 3 months
Who cannot join
- Those who have had major surgery or trauma related to the musculoskeletal system, especially the elbow region
- Steroid injection to the elbow area in the last 3 months,
- Those with neurological disease
- Those who received physiotherapeutic intervention in the elbow area in the last 3 months
- Having infection and local dermatological problems in the treatment area Those with rheumatic disease in the active period
- Those with systemic diseases (Diabetes, hypothyroidism, infection, malignancy...)
Show all 9Show fewer
- Those with serious psychological problems (BDI score of 30 and above)
- Pregnancy
- Presence of malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Eccentric Stretching on Pain, Grip Strength and Functional Level in Patients With Lateral Epicondylitis
Lateral Epicondylitis; is a disease characterized by insidious onset pain in the lateral elbow of the forearm, which radiates to the distal part of the forearm and increases with grip and wrist extension. Pain originates from the origin of the wrist and finger extensors and is more felt during repetitive, forceful wrist extension or pronation and supination, during exercise or occupational use. It is a musculoskeletal lesion. Although it is so common, no consensus has yet been reached regarding its clinic, pathophysiology, and treatment. It is known that the primary etiological factor in the pathology of lateral epicondylitis is the overloading of the aponeurosis of the joint extensor muscles attachment site. Repetitive overuse causes tendon damage with macroscopic abnormalities of tendon collagen. The final stage of tendinopathy is characterized by abnormal tendon structure and degenerative features, including neovascularization. Primary pathological changes occur at the proximal musculotendinous insertion of the Extensor carpi radialis brevis. The currently accepted theory is that the process begins with overuse injuries that lead to small tears of the extensor carpi radialis brevis, sometimes the extensor digitorum communis muscle.
The prevalence of lateral epicondylitis peaks between the ages of 35 and 55, and lateral epicondylitis primarily affects the dominant side. There is no clear consensus on the involvement of men and women, and it appears independent of gender and ethnicity [6-8]. Due to the symptoms experienced, the people's daily life activities are affected and cause loss of workforce.
Read more
Conservative therapy is usually the first line of treatment for lateral epicondylitis. Conservative treatment typically includes rest, non-steroidal anti-inflammatory drugs, and physiotherapy and rehabilitation. Physiotherapy and rehabilitation applications include activity modification, orthosis use, cold-hot application, deep friction massage, stretching and strengthening exercises, electrical stimulation, ultrasound, laser, extracorporeal shock wave therapy, and manual therapy. In addition to FTR approaches, invasive procedures such as corticosteroid/botulinum toxin/glucosamine/autologous injections, prolotherapy, acupuncture, and topical nitric oxide application can be used. In cases where conservative treatment is insufficient, surgical applications are used. Although there are many different treatment methods known in the literature, the superiority of a particular approach for the treatment of lateral epicondylitis has not yet been proven and a consensus has not been reached.
It has been known for a long time that eccentric exercises based on the extension of the muscle length can cause damage to the muscle fibers due to stretching and late-onset muscle pain. However, when they are applied in a regular and controlled manner, they adaptively strengthen and protect the muscle tissue. In clinical and animal studies, it has been found that reaching muscle length at an angle greater than the optimum angle of the muscle causes eccentric exercise, which in turn reduces muscle damage and increases joint range of motion.
Although studies continue to understand the mechanisms of post-exercise muscle damage and the protective muscle response that develops after exercise, no study has been found in the literature on eccentric stretching applied to patients with lateral epicondylitis. Therefore, the aim of our study is to investigate the effect of eccentric stretching on pain, grip strength, and functional level in patients with lateral epicondylitis.
- Conditions
- Lateral Epicondylitis
- Being tested
- Cold application+Deep friction+Home exercise+Eccentric stretching, Cold application+Deep friction+Home exercise
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold application+Deep friction+Home exercise+Eccentric stretchingOther
In our study, deep friction massage will be performed by the researcher with the tip of the thumb, maintaining the pressure for 3-5 minutes in the posterior direction to the tenoosseous junction. The application will be performed 3 times a week for a total of 12 sessions for 4 weeks. After the deep friction massage, cold application will be made for 15 minutes. Simultaneously with the electrical stimulation of the affected arm, the patient will be asked to stretch for 5 seconds and rest for 5 seconds, and doing this 15 times will be considered 1 set. After 1 minute of rest, he will be asked to do this practice for 2 more sets, so 3 sets of 15 repetitions will be completed in total. A total of 12 sessions will be applied 3 days a week for 4 weeks. In our study, a home exercise program consisting of passive stretching and strengthening (concentric and eccentric) exercises will be applied.
Cold application+Deep friction+Home exerciseOther
In our study, deep friction massage will be performed by the researcher with the tip of the thumb, maintaining the pressure for 3-5 minutes in the posterior direction to the tenoosseous junction. The application will be performed 3 times a week for a total of 12 sessions for 4 weeks. After the deep friction massage, cold application will be made for 15 minutes. In our study, a home exercise program consisting of passive stretching and strengthening (concentric and eccentric) exercises will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Cold application+Deep friction+Home exercise+Eccentric stretching Receives: Other: Cold application+Deep friction+Home exercise+Eccentric stretching |
| Control Group | Experimental | Cold application +Deep friction +Home exercise Receives: Other: Cold application+Deep friction+Home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
It will be used to objectively determine the degree of pain at rest and during activity. Visual Analogue Scale is a 10 cm line drawn in the horizontal plane on a white sheet of paper. The words "no pain" are on the left end and "the most severe pain you have ever encountered in your life" are on the right. It was explained to the patient that the severity of pain increased from left to right, and he was asked to mark the severity of his own pain separately on this line at rest and during movement. There will be 2 different evaluations as Visual Analogue Scale-Rest and Visual Analogue Scale-Activity. Evaluations will be measured at the start of treatment and at the end of the study.
Measured: 4 weeks
Grip Strength
Grip strength will be measured with the Jamar hand dynamometer while the patient is sitting in a chair with the shoulder in adduction and neutral position, elbow flexed to 90 degrees, forearm and wrist in neutral position. 3 measurements will be made for each patient and 30 seconds of rest will be given between measurements. Patients will be asked for the maximum grip they can achieve and the best result of 3 repetitions will be recorded. Measurement will also be made on the unaffected side and the power difference will be recorded.
Measured: 4 weeks
Pinchmeter
Palmar measurement is evaluated by squeezing the pinch meter with the medial of the thumb and supporting the other fingers from the lateral.
Measured: 4 weeks
Muscle Tone and Stiffness
Muscle tone and stiffness will be evaluated with a myotonometer. The myotonometer was developed for the objective measurement of mechanical muscle properties. Myotonometry reflects the viscoelastic properties of the muscle such as tone and stiffness by creating oscillation in the muscle fiber and is an acceptable and reliable method for measuring the mechanical properties of the muscle. Myotonometer can measure the firmness of tissues 2 cm below the epidermis. MyotonPRO is a new technology for assessing musculoskeletal stiffness; It is widely used in scientific fields.
Measured: 4 weeks
Patient-Rated Tennis Elbow Evaluation
Overend et al. were created to evaluate treatment specifically for lateral epicondylitis patients. Later, it was reorganized by the same study group and named the patient-based tennis elbow evaluation questionnaire (Patient-Rated Tennis Elbow Evaluation). The questionnaire consists of 15 questions questioning the difficulties and pain experienced by the patients with the elbow in the past week. In the first part, the level of pain (5 questions), and in the second part, functions related to the elbow (6 questions about special activities, 4 questions about daily activities) are evaluated. The total score ranges from 0-100, with high scores indicating increased pain and loss of functionality. A high score indicates worsening health. In 2010, Altan et al. The Turkish version was created by Patient-Rated Tennis Elbow Evaluation and it was found to be valid and reliable. The Turkish version of the questionnaire will be used in our study.
Measured: 4 weeks
Quick Disability of the Arm, Shoulder and Hand Questionnaire
Quick Disability of the Arm, Shoulder, and Hand Questionnaire is a short version that can be used to assess disability caused by musculoskeletal problems involving the upper extremity, activity limitation, as well as limitation of leisure time activities and participation in work. In all questions, the patient marks the appropriate answer on the 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not doing at all). According to the results of the Disability of the Arm, Shoulder, and Hand Questionnaire and Quick-Disability of the Arm, Shoulder, and Hand Questionnaire; A result between 0-100 is obtained from each section (0 = no excuse, 100 = maximum apology). A high score indicates worsening health.
Measured: 4 weeks
Nottingham Health Profile:-
The Nottingham Health Profile will be used in our quality of life assessment. In the questionnaire consisting of 38 items, 6 different parameters related to health status are evaluated. These parameters are physical activity (8 items), emotional reactions (9 items), energy (3 items), social isolation (5 items), pain (8 items), and sleep (5 items). Each sub-parameter is scored between 0-100. A high score indicates worsening health. The total score is obtained by summing all sub-parameter scores.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start15 Apr 2023
- Primary completion15 May 2023
- Study completion30 Jun 2023
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.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823233
- Sponsor's protocol ID
- 22-161
- Status last verified
- Sep 2023
- First submitted
- 10 Apr 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Eccentric Stretching on Pain, Grip Strength and Functional Level in Patients With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT05823233
- Acronym / sponsor ID
- 22-161
- Conditions
- Lateral Epicondylitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 21 Apr 2023 (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.
Lateral Epicondylitis; is a disease characterized by insidious onset pain in the lateral elbow of the forearm, which radiates to the distal part of the forearm and increases with grip and wrist extension. Pain originates from the origin of the wrist and finger extensors and is more felt during repetitive, forceful wrist extension or pronation and supination, during exercise or occupational use. It is a musculoskeletal lesion. Although it is so common, no consensus has yet been reached regarding its clinic, pathophysiology, and treatment. It is known that the primary etiological factor in the pathology of lateral epicondylitis is the overloading of the aponeurosis of the joint extensor muscles attachment site. Repetitive overuse causes tendon damage with macroscopic abnormalities of tendon collagen. The final stage of tendinopathy is characterized by abnormal tendon structure and degenerative features, including neovascularization. Primary pathological changes occur at the proximal musculotendinous insertion of the Extensor carpi radialis brevis. The currently accepted theory is that the process begins with overuse injuries that lead to small tears of the extensor carpi radialis brevis, sometimes the extensor digitorum communis muscle.
The prevalence of lateral epicondylitis peaks between the ages of 35 and 55, and lateral epicondylitis primarily affects the dominant side. There is no clear consensus on the involvement of men and women, and it appears independent of gender and ethnicity [6-8]. Due to the symptoms experienced, the people's daily life activities are affected and cause loss of workforce.
Conservative therapy is usually the first line of treatment for lateral epicondylitis. Conservative treatment typically includes rest, non-steroidal anti-inflammatory drugs, and physiotherapy and rehabilitation. Physiotherapy and rehabilitation applications include activity modification, orthosis use, cold-hot application, deep friction massage, stretching and strengthening exercises, electrical stimulation, ultrasound, laser, extracorporeal shock wave therapy, and manual therapy. In addition to FTR approaches, invasive procedures such as corticosteroid/botulinum toxin/glucosamine/autologous injections, prolotherapy, acupuncture, and topical nitric oxide application can be used. In cases where conservative treatment is insufficient, surgical applications are used. Although there are many different treatment methods known in the literature, the superiority of a particular approach for the treatment of lateral epicondylitis has not yet been proven and a consensus has not been reached.
It has been known for a long time that eccentric exercises based on the extension of the muscle length can cause damage to the muscle fibers due to stretching and late-onset muscle pain. However, when they are applied in a regular and controlled manner, they adaptively strengthen and protect the muscle tissue. In clinical and animal studies, it has been found that reaching muscle length at an angle greater than the optimum angle of the muscle causes eccentric exercise, which in turn reduces muscle damage and increases joint range of motion.
Although studies continue to understand the mechanisms of post-exercise muscle damage and the protective muscle response that develops after exercise, no study has been found in the literature on eccentric stretching applied to patients with lateral epicondylitis. Therefore, the aim of our study is to investigate the effect of eccentric stretching on pain, grip strength, and functional level in patients with lateral epicondylitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Cold application+Deep friction+Home exercise+Eccentric stretchingCold application+Deep friction+Home exercise+Eccentric stretching |
| Control Group | Experimental | Other: Cold application+Deep friction+Home exerciseCold application +Deep friction +Home exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between the ages of 18 - 65
- Having been diagnosed with Lateral Epicondylitis,
- Pain localized in the elbow for more than 3 months
Key exclusion criteria (9 listed)
- Those who have had major surgery or trauma related to the musculoskeletal system, especially the elbow region
- Steroid injection to the elbow area in the last 3 months,
- Those with neurological disease
- Those who received physiotherapeutic intervention in the elbow area in the last 3 months
- Having infection and local dermatological problems in the treatment area Those with rheumatic disease in the active period
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 |
|---|---|---|
| Cold application+Deep friction+Home exercise+Eccentric stretchingIn our study, deep friction massage will be performed by the researcher with the tip of the thumb, maintaining the pressure for 3-5 minutes in the posterior direction to the tenoosseous junction. The application will be performed 3 times a week for a total of 12 sessions for 4 weeks. After the deep friction massage, cold application will be made for 15 minutes. Simultaneously with the electrical stimulation of the affected arm, the patient will be asked to stretch for 5 seconds and rest for 5 seconds, and doing this 15 times will be considered 1 set. After 1 minute of rest, he will be asked to do this practice for 2 more sets, so 3 sets of 15 repetitions will be completed in total. A total of 12 sessions will be applied 3 days a week for 4 weeks. In our study, a home exercise program consisting of passive stretching and strengthening (concentric and eccentric) exercises will be applied. | Other | Study group |
| Cold application+Deep friction+Home exerciseIn our study, deep friction massage will be performed by the researcher with the tip of the thumb, maintaining the pressure for 3-5 minutes in the posterior direction to the tenoosseous junction. The application will be performed 3 times a week for a total of 12 sessions for 4 weeks. After the deep friction massage, cold application will be made for 15 minutes. In our study, a home exercise program consisting of passive stretching and strengthening (concentric and eccentric) exercises will be applied. | Other | Control Group |
Primary outcome
Visual Analogue Scale
Time frame: 4 weeks
It will be used to objectively determine the degree of pain at rest and during activity. Visual Analogue Scale is a 10 cm line drawn in the horizontal plane on a white sheet of paper. The words "no pain" are on the left end and "the most severe pain you have ever encountered in your life" are on the right. It was explained to the patient that the severity of pain increased from left to right, and he was asked to mark the severity of his own pain separately on this line at rest and during movement. There will be 2 different evaluations as Visual Analogue Scale-Rest and Visual Analogue Scale-Activity. Evaluations will be measured at the start of treatment and at the end of the study.
Grip Strength
Time frame: 4 weeks
Grip strength will be measured with the Jamar hand dynamometer while the patient is sitting in a chair with the shoulder in adduction and neutral position, elbow flexed to 90 degrees, forearm and wrist in neutral position. 3 measurements will be made for each patient and 30 seconds of rest will be given between measurements. Patients will be asked for the maximum grip they can achieve and the best result of 3 repetitions will be recorded. Measurement will also be made on the unaffected side and the power difference will be recorded.
Pinchmeter
Time frame: 4 weeks
Palmar measurement is evaluated by squeezing the pinch meter with the medial of the thumb and supporting the other fingers from the lateral.
Muscle Tone and Stiffness
Time frame: 4 weeks
Muscle tone and stiffness will be evaluated with a myotonometer. The myotonometer was developed for the objective measurement of mechanical muscle properties. Myotonometry reflects the viscoelastic properties of the muscle such as tone and stiffness by creating oscillation in the muscle fiber and is an acceptable and reliable method for measuring the mechanical properties of the muscle. Myotonometer can measure the firmness of tissues 2 cm below the epidermis. MyotonPRO is a new technology for assessing musculoskeletal stiffness; It is widely used in scientific fields.
Patient-Rated Tennis Elbow Evaluation
Time frame: 4 weeks
Overend et al. were created to evaluate treatment specifically for lateral epicondylitis patients. Later, it was reorganized by the same study group and named the patient-based tennis elbow evaluation questionnaire (Patient-Rated Tennis Elbow Evaluation). The questionnaire consists of 15 questions questioning the difficulties and pain experienced by the patients with the elbow in the past week. In the first part, the level of pain (5 questions), and in the second part, functions related to the elbow (6 questions about special activities, 4 questions about daily activities) are evaluated. The total score ranges from 0-100, with high scores indicating increased pain and loss of functionality. A high score indicates worsening health. In 2010, Altan et al. The Turkish version was created by Patient-Rated Tennis Elbow Evaluation and it was found to be valid and reliable. The Turkish version of the questionnaire will be used in our study.
Quick Disability of the Arm, Shoulder and Hand Questionnaire
Time frame: 4 weeks
Quick Disability of the Arm, Shoulder, and Hand Questionnaire is a short version that can be used to assess disability caused by musculoskeletal problems involving the upper extremity, activity limitation, as well as limitation of leisure time activities and participation in work. In all questions, the patient marks the appropriate answer on the 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not doing at all). According to the results of the Disability of the Arm, Shoulder, and Hand Questionnaire and Quick-Disability of the Arm, Shoulder, and Hand Questionnaire; A result between 0-100 is obtained from each section (0 = no excuse, 100 = maximum apology). A high score indicates worsening health.
Nottingham Health Profile:-
Time frame: 4 weeks
The Nottingham Health Profile will be used in our quality of life assessment. In the questionnaire consisting of 38 items, 6 different parameters related to health status are evaluated. These parameters are physical activity (8 items), emotional reactions (9 items), energy (3 items), social isolation (5 items), pain (8 items), and sleep (5 items). Each sub-parameter is scored between 0-100. A high score indicates worsening health. The total score is obtained by summing all sub-parameter scores.
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 21 Sep 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold application+Deep friction+Home exercise+Eccentric stretching and Cold application+Deep friction+Home exercise in people with Lateral Epicondylitis, run by Istinye University at 1 site 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 3 inclusion and 9 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Visual Analogue Scale (time frame: 4 weeks). The study lists 7 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 21 Sep 2023.