Lateral EpicondylitisNCT05504759
Efficacy of Dry Needling in the Treatment of Lateral Epicondylitis
A study testing splint, steroid and dry needling in people with Lateral Epicondylitis, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
In this study, investigators aimed to investigate the effects of rest, steroid injection and dry needling treatments, which are frequently used in the treatment of patients diagnosed with lateral epicondylitis (tennis elbow), on the pain and functional status of the patients. 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?
- splint, steroid and dry needling
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2021to 2 Aug 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
- Patients aged 18-65 years with pain in the lateral humeral epicondyle region for at least 6 weeks
- Patients with pain on palpation of the lateral humeral epicondyle and patients with lateral epicondyle pain manifested by at least one of the provocative tests, such as resistant middle finger extension or resistant wrist extension or passively stretching the wrist extensors
- Patients with painful trigger points detected by palpation in the extensor group muscles of the forearm
Who cannot join
- History of upper extremity trauma or surgery
- History of arthritis in the upper extremity
- Patients with EMG-proven entrapment neuropathy in the upper extremity
- Patients with cervical radiculopathy
- History of interventional procedures such as physical therapy or steroid injection for lateral epicondylitis in the last 3 months
- Pregnancy and pregnancy
Show all 9Show fewer
- Patients with complaint duration less than 6 weeks
- Having mental (intelligence-related) problems, limitation of cooperation-orientation (being aware of time and space and having communication skills)
- <18 years, >65 years
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan 2. Abdulhamid Han Training and Research Hospital
Istanbul
Ömer Faruk Ünelli, M.D., 05069195869, funelli@hotmail.com
About this study
Official title: Evaluation of the Efficacy of Dry Needling Treatment of Wrist Extensor Muscles in the Treatment of Lateral Epicondylitis
In this study, investigators aimed to investigate the effects of rest, steroid injection and dry needling treatments, which are frequently used in the treatment of patients diagnosed with lateral epicondylitis (tennis elbow), on the pain and functional status of the patients.
Read the detailed description
Lateral epicondylitis is one of the most common painful conditions of the arm, characterized by pain in the lateral epicondyle where the wrist extensors muscles originate and on the extensor muscle surface of the forearm, and is also called tennis elbow. The incidence of lateral epicondylitis has been reported as 1-3%. The age of onset is between 35 and 50, and it is more common in men. Mostly the dominant arm is affected, rarely bilateral. It may occur as a result of repetitive and difficult wrist extension. Tenderness in the lateral epicondyle, pain that can be revealed with resistant wrist extension and middle finger extension, decrease in grip strength and significant limitation in daily living activities are the main findings. The repetition of the movement is more important than the force required to perform the movement in the development of the symptoms. Extensor muscles are under extreme stress in those who work in jobs that require continuous rotation of the wrist, such as grasping, supination, and pronation, or in these types of sports. As a result of forcing, soft tissues such as muscles, ligaments and tendons in the forearm cannot meet the load they are exposed to, and thus symptoms occur. Although it originates from the muscle extensor carpi radialis brevis (ECRB), where pathological changes are primarily seen; It can also be seen at the origin of the extensor carpi radialis longus (ECRL) and extensor digitorum communis (EDK) muscles. Myofascial trigger points formed in the forearm extensor group muscles are frequently detected during examination.
The basic principles of treatment in lateral epicondylitis are to relieve pain, accelerate the healing process, reduce overloads on the arm, and enable the patient to return to daily life activities. Conservative treatment options are rest, splint, ice application, electrotherapy, massage, manipulation, mobilization, exercise and medical therapy.
When investigators examine the literature, although there are many studies on conservative methods and steroid injection in the treatment of lateral epicondylitis; investigatorsfound several studies on the effectiveness of dry needling in lateral epicondylitis. In the current study, the efficacy of dry needling was compared with the conservative method, which is only the first-line treatment. In addition, in these studies, dry needling was applied to the musculeutendinous junction. Investigators observed that lateral epicondylitis is a disease that is activated by tendinopathy and can cause multiple painful tender points and tight bands in the forearm muscles. In this context, investigators think that more studies are needed on the effectiveness of dry needling in lateral epicondylitis. In this study, investigators aimed to investigate the effects of rest, steroid injection and dry needling treatments, which are frequently used in the treatment of patients diagnosed with lateral epicondylitis (tennis elbow), on the pain and functional status of the patients.
The first stage of treatment is rest, orthoses can also be used in this regard. The use of a forearm support band and a splint to keep the wrist at 20 degrees of extension also helps to keep the extensor muscles in a relaxed position, resting these muscles.
At the end of the 2-week rest period, patients are given strengthening and stretching exercises. Strengthening the wrist extensors increases the tolerance of the damaged attachment to repetitive and resistant movement. Mills maneuver, that is, extension of the elbow, pronation of the forearm, flexion of the wrist and ulnar deviation as a stretching exercise for 30-45 seconds. applicable. The goal with stretching is to lengthen the scar tissue.
Ultrasound, iontophoresis, laser, interference currents, electrical stimulation, ESWT are physical therapy methods used in lateral epicondylitis. In addition to the analgesic effects of these treatment methods, their contribution to the healing process of the damaged tissue has also been reported.In addition, various injection methods (steroid injection, prolotherapy, platelet rich plasma (PRP), dry needling) are also used in the routine treatment of lateral epicondylitis.
Many treatment methods have been reported in the studies on the treatment of lateral epicondylitis, but in general, insufficient number of patients and short follow-up periods are stated as the missing aspects of the studies. The aim of our study is to evaluate in detail the methods used in the routine for treatment, which do not have side effects and are comfortable, and compare the superiority of the methods to each other. In addition, by examining the efficacy of treatment with sufficient number of patients and follow-up period in our study; It is aimed to contribute to the literature by evaluating the methods in terms of safety, effectiveness, efficiency, accessibility, quality and determining the most appropriate methods for clinical practice.
- Conditions
- Lateral Epicondylitis
- Being tested
- splint, steroid, dry needling
- Keywords
- tennis elbow, dry needling
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
splintOther
Resting is the first step of treatment in lateral epicondylitis. Patients will be given a 2 weeks rest protocol (works that may cause strain on the wrist and increase elbow pain will be described and it will be advised to stay away, and a home exercise program will be prepared, which includes the use of a resting splint during the daytime for 2 weeks). The goal of exercise therapy will be to stretch the muscles, strengthen them and maintain flexibility. Home exercises during the treatment of lateral epicondylitis will be beneficial when performed twice a day for at least three months, and stretching exercises will be performed first, and then strengthening exercises will be started in a controlled manner.
steroidOther
Betamethasone Dipropionate + Betamethasone Sodium Phosphate-1 ml will be administered once at the beginning of the study to patients who will receive steroid injection, one of the local injection treatments. Steroid injection will be applied to the most sensitive point on the lateral epicondyle. Afterwards, patients will be given a 2 weeks rest protocol (works that may cause strain on the wrist and increase elbow pain will be described and it will be advised to stay away, and a home exercise program will be prepared, which includes the use of a resting splint during daytime hours for 2 weeks). The goal of exercise therapy will be to stretch the muscles, strengthen them and maintain flexibility. Home exercises during the treatment of lateral epicondylitis will be beneficial when performed twice a day for at least three months, and stretching exercises will be performed first, and then strengthening exercises will be started in a controlled manner.
dry needlingOther
The needle will be guided to painful trigger points detected by palpation. Stainless steel 25x30 mm needles will be used for dry needling. Dry needle treatment will be applied to the painful trigger points in the forearm extensor group muscles with the stick-pull technique, 1 session per week, for a total of 2 sessions. Afterwards, the patients will be given a 2 weeks rest protocol (works that may strain the wrist and increase elbow pain will be described and it will be advised to stay away, and a home exercise program will be prepared, which includes the use of a resting splint during the daytime for 2 weeks). The purpose of exercise therapy will be to stretch the muscles, strengthen them and maintain flexibility. During the treatment of lateral epicondylitis, home exercises will be beneficial when performed twice a day for at least three months, and stretching exercises will be performed first, and then strengthening exercises will be started in a controlled manner.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 2 weeks rest protocol + standardized exercise program Receives: Other: splint |
| Group 2 | Experimental | local steroid injection + 2 weeks rest protocol + standardized exercise program Receives: Other: splint; Other: steroid |
| Group 3 | Experimental | dry needling of forearm extensor muscles + 2 weeks rest protocol + standardized exercise program Receives: Other: splint; Other: dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in elbow pain after treatment as assessed by vas
Elbow pain will be measured with the Visual Analog Scale (VAS).The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing. For example, for pain, I have no pain at one end and very severe pain at the other end and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.
Measured: before treatment, second-month control after treatment
Secondary outcomes (1)
Hand grip strength
It will be evaluated with the Jamar hydraulic hand dynamometer.The purpose of this test is to test the maximum isometric contraction strength of the hand and forearm muscles. A hand grip dynamometer is required to perform the test (such as Jamar™, Camry™, Smedley™). Dynamometer Examples Grip strength should be evaluated while the patient is sitting in the chair. The elbows are kept close to the body and at 90° flexion. The wrist is in neutral. The person to be measured is asked to grasp the dynamometer and squeeze it as hard as he can. The test result is determined by calculating the average of the three measurements. Norm values for measurement: 47-40kg for men aged 20-69 (left hand 2 kg less) 30-24kg for women (1.5-2kg less for left hand)
Measured: before treatment, second-month control after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start2 Feb 2021
- Primary completion2 Jun 2023 (estimated)
- Study completion2 Aug 2023 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Ata, Assoc Prof, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Emre Ata, Ass.Prof., Principal investigator, Sultan II. Abdulhamidhan Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504759
- Sponsor's protocol ID
- 2166
- Status last verified
- Aug 2022
- First submitted
- 31 Mar 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Dry Needling Treatment of Wrist Extensor Muscles in the Treatment of Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT05504759
- Acronym / sponsor ID
- 2166
- Conditions
- Lateral Epicondylitis
- Keywords
- tennis elbow, dry needling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 2 Jun 2023 (estimated)
- Study completion
- 2 Aug 2023 (estimated)
- First posted
- 17 Aug 2022 (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.
In this study, investigators aimed to investigate the effects of rest, steroid injection and dry needling treatments, which are frequently used in the treatment of patients diagnosed with lateral epicondylitis (tennis elbow), on the pain and functional status of the patients.
Detailed description
Lateral epicondylitis is one of the most common painful conditions of the arm, characterized by pain in the lateral epicondyle where the wrist extensors muscles originate and on the extensor muscle surface of the forearm, and is also called tennis elbow. The incidence of lateral epicondylitis has been reported as 1-3%. The age of onset is between 35 and 50, and it is more common in men. Mostly the dominant arm is affected, rarely bilateral. It may occur as a result of repetitive and difficult wrist extension. Tenderness in the lateral epicondyle, pain that can be revealed with resistant wrist extension and middle finger extension, decrease in grip strength and significant limitation in daily living activities are the main findings. The repetition of the movement is more important than the force required to perform the movement in the development of the symptoms. Extensor muscles are under extreme stress in those who work in jobs that require continuous rotation of the wrist, such as grasping, supination, and pronation, or in these types of sports. As a result of forcing, soft tissues such as muscles, ligaments and tendons in the forearm cannot meet the load they are exposed to, and thus symptoms occur. Although it originates from the muscle extensor carpi radialis brevis (ECRB), where pathological changes are primarily seen; It can also be seen at the origin of the extensor carpi radialis longus (ECRL) and extensor digitorum communis (EDK) muscles. Myofascial trigger points formed in the forearm extensor group muscles are frequently detected during examination.
The basic principles of treatment in lateral epicondylitis are to relieve pain, accelerate the healing process, reduce overloads on the arm, and enable the patient to return to daily life activities. Conservative treatment options are rest, splint, ice application, electrotherapy, massage, manipulation, mobilization, exercise and medical therapy.
When investigators examine the literature, although there are many studies on conservative methods and steroid injection in the treatment of lateral epicondylitis; investigatorsfound several studies on the effectiveness of dry needling in lateral epicondylitis. In the current study, the efficacy of dry needling was compared with the conservative method, which is only the first-line treatment. In addition, in these studies, dry needling was applied to the musculeutendinous junction. Investigators observed that lateral epicondylitis is a disease that is activated by tendinopathy and can cause multiple painful tender points and tight bands in the forearm muscles. In this context, investigators think that more studies are needed on the effectiveness of dry needling in lateral epicondylitis. In this study, investigators aimed to investigate the effects of rest, steroid injection and dry needling treatments, which are frequently used in the treatment of patients diagnosed with lateral epicondylitis (tennis elbow), on the pain and functional status of the patients.
The first stage of treatment is rest, orthoses can also be used in this regard. The use of a forearm support band and a splint to keep the wrist at 20 degrees of extension also helps to keep the extensor muscles in a relaxed position, resting these muscles.
At the end of the 2-week rest period, patients are given strengthening and stretching exercises. Strengthening the wrist extensors increases the tolerance of the damaged attachment to repetitive and resistant movement. Mills maneuver, that is, extension of the elbow, pronation of the forearm, flexion of the wrist and ulnar deviation as a stretching exercise for 30-45 seconds. applicable. The goal with stretching is to lengthen the scar tissue.
Ultrasound, iontophoresis, laser, interference currents, electrical stimulation, ESWT are physical therapy methods used in lateral epicondylitis. In addition to the analgesic effects of these treatment methods, their contribution to the healing process of the damaged tissue has also been reported.In addition, various injection methods (steroid injection, prolotherapy, platelet rich plasma (PRP), dry needling) are also used in the routine treatment of lateral epicondylitis.
Many treatment methods have been reported in the studies on the treatment of lateral epicondylitis, but in general, insufficient number of patients and short follow-up periods are stated as the missing aspects of the studies. The aim of our study is to evaluate in detail the methods used in the routine for treatment, which do not have side effects and are comfortable, and compare the superiority of the methods to each other. In addition, by examining the efficacy of treatment with sufficient number of patients and follow-up period in our study; It is aimed to contribute to the literature by evaluating the methods in terms of safety, effectiveness, efficiency, accessibility, quality and determining the most appropriate methods for clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: splint2 weeks rest protocol + standardized exercise program |
| Group 2 | Experimental | Other: splint, Other: steroidlocal steroid injection + 2 weeks rest protocol + standardized exercise program |
| Group 3 | Experimental | Other: splint, Other: dry needlingdry needling of forearm extensor muscles + 2 weeks rest protocol + standardized exercise program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-65 years with pain in the lateral humeral epicondyle region for at least 6 weeks
- Patients with pain on palpation of the lateral humeral epicondyle and patients with lateral epicondyle pain manifested by at least one of the provocative tests, such as resistant middle finger extension or resistant wrist extension or passively stretching the wrist extensors
- Patients with painful trigger points detected by palpation in the extensor group muscles of the forearm
Key exclusion criteria (9 listed)
- History of upper extremity trauma or surgery
- History of arthritis in the upper extremity
- Patients with EMG-proven entrapment neuropathy in the upper extremity
- Patients with cervical radiculopathy
- History of interventional procedures such as physical therapy or steroid injection for lateral epicondylitis in the last 3 months
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 |
|---|---|---|
| splintResting is the first step of treatment in lateral epicondylitis. Patients will be given a 2 weeks rest protocol (works that may cause strain on the wrist and increase elbow pain will be described and it will be advised to stay away, and a home exercise program will be prepared, which includes the use of a resting splint during the daytime for 2 weeks). The goal of exercise therapy will be to stretch the muscles, strengthen them and maintain flexibility. Home exercises during the treatment of lateral epicondylitis will be beneficial when performed twice a day for at least three months, and stretching exercises will be performed first, and then strengthening exercises will be started in a controlled manner. | Other | Group 1, Group 2, Group 3 |
| steroidBetamethasone Dipropionate + Betamethasone Sodium Phosphate-1 ml will be administered once at the beginning of the study to patients who will receive steroid injection, one of the local injection treatments. Steroid injection will be applied to the most sensitive point on the lateral epicondyle. Afterwards, patients will be given a 2 weeks rest protocol (works that may cause strain on the wrist and increase elbow pain will be described and it will be advised to stay away, and a home exercise program will be prepared, which includes the use of a resting splint during daytime hours for 2 weeks). The goal of exercise therapy will be to stretch the muscles, strengthen them and maintain flexibility. Home exercises during the treatment of lateral epicondylitis will be beneficial when performed twice a day for at least three months, and stretching exercises will be performed first, and then strengthening exercises will be started in a controlled manner. | Other | Group 2 |
| dry needlingThe needle will be guided to painful trigger points detected by palpation. Stainless steel 25x30 mm needles will be used for dry needling. Dry needle treatment will be applied to the painful trigger points in the forearm extensor group muscles with the stick-pull technique, 1 session per week, for a total of 2 sessions. Afterwards, the patients will be given a 2 weeks rest protocol (works that may strain the wrist and increase elbow pain will be described and it will be advised to stay away, and a home exercise program will be prepared, which includes the use of a resting splint during the daytime for 2 weeks). The purpose of exercise therapy will be to stretch the muscles, strengthen them and maintain flexibility. During the treatment of lateral epicondylitis, home exercises will be beneficial when performed twice a day for at least three months, and stretching exercises will be performed first, and then strengthening exercises will be started in a controlled manner. | Other | Group 3 |
Primary outcome
change in elbow pain after treatment as assessed by vas
Time frame: before treatment, second-month control after treatment
Elbow pain will be measured with the Visual Analog Scale (VAS).The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing. For example, for pain, I have no pain at one end and very severe pain at the other end and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.
1 secondary outcome
Hand grip strength
Time frame: before treatment, second-month control after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
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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.
Emre Ata, Ass.Prof. principal investigator
Sultan II. Abdulhamidhan Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing splint, steroid and dry needling in people with Lateral Epicondylitis, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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: status not confirmed, as of the sponsor's last update on 17 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ömer Faruk Ünelli, MD (05069195869, funelli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in elbow pain after treatment as assessed by vas (time frame: before treatment, second-month control after treatment). 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 17 Aug 2022.