Tennis ElbowNCT04505215
Comparison of Mulligan Technique and Muscle Energy Technique in Lateral Epicondylitis
A study testing Mulligan Technique and Muscle Energy Technique in people with Tennis Elbow, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effects of mulligan and muscle energy techniques on pain, grip strength and functionality will be investigated in a randomized controlled manner in individuals with lateral epicondylitis. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- Mulligan Technique and Muscle Energy Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Aug 2020to 14 Nov 2020
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosing lateral epicondylitis
- Age between 30 and 60 years
- Willingness to comply with treatment and follow-up assessments
Who cannot join
- Treatment of elbow complaints with surgical intervention
- Physiotherapy or CSIs in the past 6 months
- Duration of <3 months
- Severe neck or shoulder problems likely to cause or maintain the elbow complaints
- Posterior interosseous nerve compression
- Congenital or acquired deformities of the elbow
- Systemic musculoskeletal or neurologic disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Mulligan and Muscle Energy Techniques on Pain, Grip Strength and Functionality in Individuals With Lateral Epicondylitis
In this study, the effects of mulligan and muscle energy techniques on pain, grip strength and functionality will be investigated in a randomized controlled manner in individuals with lateral epicondylitis. Various treatments have been tried in patients with lateral epicondylitis whose daily activities are restricted in order to reduce pain and increase functions. Among them, conservative and physical therapy agents have an important place. There are many studies in the literature evaluating the effects of mobilization in LE treatment. However, there are no definitive data on the long-term efficacy and benefits of all these treatment methods. Mulligan and muscle energy techniques can be used in lateral epicondylitis due to many positive reasons such as being effective in a short time, giving fast results, high success rate, risk-free and painless in the case of specialists. Thanks to the findings obtained from our study, it is aimed to contribute to the literature with objective, evidence-based results in this field.
Read the detailed description
Lateral epicondylitis (LE); It is one of the most common lesions of the upper limb, originating from the wrist and wrist extensor muscles, characterized by pain in the lateral epicondyle and extensor muscle surface of the forearm. LE was first described by Runge in 1873 and was named tennis elbow by Morris in 1882. It is thought that the cause of LE is caused by repetitive stresses, direct traumas, repetitive contractions, degeneration, micro tears, immature repair and tendinosis at the adhesion of the extensor carpi radialis brevis and extensor digitorum communis muscles. It is mostly seen in 4-6 decades. More dominant upper limb is affected. Its annual incidence has been determined between 1-3%. It has been shown that it can cause a significant loss of labor due to pain in patients.
The Mulligan Concept is a new approach in Manual Therapy. It was started to be developed by New Zealand physiotherapist Brian Mulligan in the 1980s, and its popularity and awareness has increased in the last 10 years. The concept-specific techniques called NAGS, SNAGS and MWMs are applied safely and effectively in musculoskeletal-nervous system diseases. The concept is suitable for biomechanics, arthrokinematic kinesiological principles, which are the common knowledge of the known Manual Therapy approaches, and techniques and application principles are important with other approaches. show differences.
Manual therapy and forearm extensor muscle strengthening are used together with MWM (mobilization with movement) technique. MWM eliminates elbow pain by reducing abnormal facilitations and creates some tactile and compressive stimuli in soft tissue. Afferent nerve activity results in these tactile and compressive stimuli inhibiting spinal cord neurons. Force is applied at long load at low load. Increases the harmony and mobility of connective tissue layers.
Mulligan concept; It can be defined as a combination of passive mobilization concepts such as Kaltenborn, Maitland Cyriax, and active methods such as Pilates, PNF and Kinetic Control. The distinctive feature of this approach is that, when the right case is chosen, the pain can be achieved, functional gains can be achieved in a very short time and in the long term.
Postisometric reconstruction: muscle energy technique (MET) is a manual therapy that uses muscle's own energy in the form of mild isometric contractions to relax and lengthen muscles through autogenic or mutual inhibition. Compared to static stretching, a passive technique in which the therapist does all the work, MET is an active technique in which the patient is also an active participant. BAT is based on the concepts of Autogenic Inhibition and Mutual Inhibition. If a maximum contraction of the muscle is followed by the stretching of the same muscle, Autogenic Inhibition is known as MET, and if the opposite muscle following a maximum contraction of the muscle is stretched, it is known as Mutual Inhibition MET.
The manipulative treatment acts directly on the joint structures and creates a nociceptive afferent stimulation by providing physiological effect on the central nervous system. Such findings emphasize the appropriateness of the local movements of mobilization. Such a mechanism may include intranoral circulation, axoplasmic flow, or neural connective tissue viscoelasticity. However, an increasing number of studies have shown that passive joint movements can activate many areas.
Exercise programs are the most common physiotherapy treatments for LE. There are many studies examining the effects of exercise programs in LE. Stretching and strengthening exercises are at the core of the exercise program. Because the tendon should not only be strengthened, it should be flexible. Home exercises should usually be done once or twice a day.
- Conditions
- Tennis Elbow
- Being tested
- Mulligan Technique, Muscle Energy Technique, Only Exercise (Control)
- Keywords
- Tennis Elbow, Exercise, Musculoskeletal Manipulations
- Medical subject headings
- Tennis Elbow, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan TechniqueOther
First, the painless application angle was determined for each patient. The lateral condyle of the humerus was fixed by the web range of the physiotherapist. The elbow joint was glided until the elbow joint and the hand tightening position were not able to cause pain.
The patients were asked to repeat the motion of the elbow joint and the ball squeezing motion given to their hands 10 times without pain. For pain control, the same procedure was performed with three sets, each containing 10 repetitions of the exercise. The interval between sets was 15 to 20 seconds, and the interval between repetitions within each set was 30 seconds.
Muscle Energy TechniqueOther
Firstly, 5-7 sec opposite isometric muscle contraction was requested from the patient in the barrier by passively stretching by the physiotherapist until the barrier of the related muscle or dysfunctional joint. After a short rest period of 2-3 seconds, the physiotherapist continued to stretch passively until the second barrier. The application continued until the tension of the muscle or dysfunction of the joint disappeared.
Only Exercise (Control)Other
Eccentric training for the extensor Carpi Radialis Brevis (ECRB) muscle, the most affected wrist extensor tendon, and static stretching exercise for the EKRB muscle were given as home exercise program. The best stretching position for the EKRB tendon is provided when the elbow joint is in extension, forearm pronation, when the wrist is flexed with ulnar deviation (Mills maneuver). Each exercise was taught to patients in 10 repetitions and 10 seconds, and one day of the week, participants in the control group performed their exercises under the supervision of a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Mulligan Technique | Experimental | In addition to the exercises applied to the participants in the control group, the participants in this group used Mobilization with movement, which was performed with the principle of painless movement 3 times a week for a total of 12 times a week for 4 weeks. Mobilization with movement has been performed by a certified physiotherapist who has been practicing this technique for 10 years. Receives: Other: Mulligan Technique |
| Muscle Energy Technique | Experimental | In addition to the exercises applied to the participants in the control group, the Janda method (Post Isometric Relaxation Technique) from Muscle Energy Technique (3 times a week) was used 3 times a week for 4 weeks. Receives: Other: Muscle Energy Technique |
| Only Exercise (Control) | Active comparator | Stretching and strengthening exercises for the forearm extensors were shown to the participants in the control group for 4 weeks every day of the week. Receives: Other: Only Exercise (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Hand Grip Strenght at 6 weeks
The maximum grip force measurements of the patients were made with "Baseline Hydraulic Hand Dynamometer". The patient's measurements were carried out in two positions. While the patient was in a sitting position, measurements were made in shoulder adduction, elbow 90˚ flexion, forearm in neutral position, wrist in 0-30˚ extension and 0-15˚ in ulnar deviation position. While the patient was standing, measurement was performed with shoulder adduction, elbow extension, forearm in neutral position. For maximum grip, patients should be able to hold the dynamometer for a maximum of 3 seconds. it was said to tighten with all its might. Measurements were repeated 3 times at 30-second intervals on the affected limb, and the measurements were averaged. Values are noted in kilograms (kg) - force
Measured: Baseline and 4 weeks
Change from baseline in Pain Score at 6 weeks
Visual Analogue Scale was used to determine the severity of rest, activity and night pain in patients with lateral epicondylitis. Patients were asked to mark their pain levels on a 10 cm scale before starting treatment and after 4 weeks of treatment. The value "0" means that there is no pain, and the value "10" means unbearable pain. The marked points are measured and recorded in centimeters
Measured: Baseline and 4 weeks
Secondary outcomes (1)
Change from baseline in Functionality at 6 weeks
Patient-rated Forearm Evaluation Questionnaire Overend et al. It was designed to evaluate treatment specifically for patients with lateral epicondylitis. Afterwards, it was rearranged by the same working group and named as Patient-rated Forearm Evaluation Questionnaire. The survey consists of 15 questions that question patients' difficulties and pain in the past week. Pain level (5 questions), elbow-related functions (6 questions, special activities, 4 questions daily activities) are evaluated in the first section. The total score ranges from 0 to 100, and high scores indicate increased pain and loss of functionality. In 2010, Altan et al. Turkish version was created by, Patient-rated Forearm Evaluation Questionnaire was found valid and reliable. Turkish version of the questionnaire was used in our study.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start14 Aug 2020
- Primary completion7 Nov 2020
- Study completion14 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bayram Sönmez ÜNÜVAR, Principal investigator, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505215
- Sponsor's protocol ID
- KaratayUS
- Status last verified
- Aug 2020
- First submitted
- 23 Jul 2020
- Last updated
- 8 Sep 2021
- 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 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Mulligan and Muscle Energy Techniques on Pain, Grip Strength and Functionality in Individuals With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT04505215
- Acronym / sponsor ID
- KaratayUS
- Conditions
- Tennis Elbow
- Keywords
- Tennis Elbow, Exercise, Musculoskeletal Manipulations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 7 Nov 2020 (actual)
- Study completion
- 14 Nov 2020 (actual)
- First posted
- 10 Aug 2020 (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, the effects of mulligan and muscle energy techniques on pain, grip strength and functionality will be investigated in a randomized controlled manner in individuals with lateral epicondylitis. Various treatments have been tried in patients with lateral epicondylitis whose daily activities are restricted in order to reduce pain and increase functions. Among them, conservative and physical therapy agents have an important place. There are many studies in the literature evaluating the effects of mobilization in LE treatment. However, there are no definitive data on the long-term efficacy and benefits of all these treatment methods. Mulligan and muscle energy techniques can be used in lateral epicondylitis due to many positive reasons such as being effective in a short time, giving fast results, high success rate, risk-free and painless in the case of specialists. Thanks to the findings obtained from our study, it is aimed to contribute to the literature with objective, evidence-based results in this field.
Detailed description
Lateral epicondylitis (LE); It is one of the most common lesions of the upper limb, originating from the wrist and wrist extensor muscles, characterized by pain in the lateral epicondyle and extensor muscle surface of the forearm. LE was first described by Runge in 1873 and was named tennis elbow by Morris in 1882. It is thought that the cause of LE is caused by repetitive stresses, direct traumas, repetitive contractions, degeneration, micro tears, immature repair and tendinosis at the adhesion of the extensor carpi radialis brevis and extensor digitorum communis muscles. It is mostly seen in 4-6 decades. More dominant upper limb is affected. Its annual incidence has been determined between 1-3%. It has been shown that it can cause a significant loss of labor due to pain in patients.
The Mulligan Concept is a new approach in Manual Therapy. It was started to be developed by New Zealand physiotherapist Brian Mulligan in the 1980s, and its popularity and awareness has increased in the last 10 years. The concept-specific techniques called NAGS, SNAGS and MWMs are applied safely and effectively in musculoskeletal-nervous system diseases. The concept is suitable for biomechanics, arthrokinematic kinesiological principles, which are the common knowledge of the known Manual Therapy approaches, and techniques and application principles are important with other approaches. show differences.
Manual therapy and forearm extensor muscle strengthening are used together with MWM (mobilization with movement) technique. MWM eliminates elbow pain by reducing abnormal facilitations and creates some tactile and compressive stimuli in soft tissue. Afferent nerve activity results in these tactile and compressive stimuli inhibiting spinal cord neurons. Force is applied at long load at low load. Increases the harmony and mobility of connective tissue layers.
Mulligan concept; It can be defined as a combination of passive mobilization concepts such as Kaltenborn, Maitland Cyriax, and active methods such as Pilates, PNF and Kinetic Control. The distinctive feature of this approach is that, when the right case is chosen, the pain can be achieved, functional gains can be achieved in a very short time and in the long term.
Postisometric reconstruction: muscle energy technique (MET) is a manual therapy that uses muscle's own energy in the form of mild isometric contractions to relax and lengthen muscles through autogenic or mutual inhibition. Compared to static stretching, a passive technique in which the therapist does all the work, MET is an active technique in which the patient is also an active participant. BAT is based on the concepts of Autogenic Inhibition and Mutual Inhibition. If a maximum contraction of the muscle is followed by the stretching of the same muscle, Autogenic Inhibition is known as MET, and if the opposite muscle following a maximum contraction of the muscle is stretched, it is known as Mutual Inhibition MET.
The manipulative treatment acts directly on the joint structures and creates a nociceptive afferent stimulation by providing physiological effect on the central nervous system. Such findings emphasize the appropriateness of the local movements of mobilization. Such a mechanism may include intranoral circulation, axoplasmic flow, or neural connective tissue viscoelasticity. However, an increasing number of studies have shown that passive joint movements can activate many areas.
Exercise programs are the most common physiotherapy treatments for LE. There are many studies examining the effects of exercise programs in LE. Stretching and strengthening exercises are at the core of the exercise program. Because the tendon should not only be strengthened, it should be flexible. Home exercises should usually be done once or twice a day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mulligan Technique | Experimental | Other: Mulligan TechniqueIn addition to the exercises applied to the participants in the control group, the participants in this group used Mobilization with movement, which was performed with the principle of painless movement 3 times a week for a total of 12 times a week for 4 weeks. Mobilization with movement has been performed by a certified physiotherapist who has been practicing this technique for 10 years. |
| Muscle Energy Technique | Experimental | Other: Muscle Energy TechniqueIn addition to the exercises applied to the participants in the control group, the Janda method (Post Isometric Relaxation Technique) from Muscle Energy Technique (3 times a week) was used 3 times a week for 4 weeks. |
| Only Exercise (Control) | Active comparator | Other: Only Exercise (Control)Stretching and strengthening exercises for the forearm extensors were shown to the participants in the control group for 4 weeks every day of the week. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosing lateral epicondylitis
- Age between 30 and 60 years
- Willingness to comply with treatment and follow-up assessments
Key exclusion criteria (7 listed)
- Treatment of elbow complaints with surgical intervention
- Physiotherapy or CSIs in the past 6 months
- Duration of <3 months
- Severe neck or shoulder problems likely to cause or maintain the elbow complaints
- Posterior interosseous nerve compression
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 |
|---|---|---|
| Mulligan TechniqueFirst, the painless application angle was determined for each patient. The lateral condyle of the humerus was fixed by the web range of the physiotherapist. The elbow joint was glided until the elbow joint and the hand tightening position were not able to cause pain. The patients were asked to repeat the motion of the elbow joint and the ball squeezing motion given to their hands 10 times without pain. For pain control, the same procedure was performed with three sets, each containing 10 repetitions of the exercise. The interval between sets was 15 to 20 seconds, and the interval between repetitions within each set was 30 seconds. | Other | Mulligan Technique |
| Muscle Energy TechniqueFirstly, 5-7 sec opposite isometric muscle contraction was requested from the patient in the barrier by passively stretching by the physiotherapist until the barrier of the related muscle or dysfunctional joint. After a short rest period of 2-3 seconds, the physiotherapist continued to stretch passively until the second barrier. The application continued until the tension of the muscle or dysfunction of the joint disappeared. | Other | Muscle Energy Technique |
| Only Exercise (Control)Eccentric training for the extensor Carpi Radialis Brevis (ECRB) muscle, the most affected wrist extensor tendon, and static stretching exercise for the EKRB muscle were given as home exercise program. The best stretching position for the EKRB tendon is provided when the elbow joint is in extension, forearm pronation, when the wrist is flexed with ulnar deviation (Mills maneuver). Each exercise was taught to patients in 10 repetitions and 10 seconds, and one day of the week, participants in the control group performed their exercises under the supervision of a physiotherapist. | Other | Only Exercise (Control) |
Primary outcome
Change from baseline in Hand Grip Strenght at 6 weeks
Time frame: Baseline and 4 weeks
The maximum grip force measurements of the patients were made with "Baseline Hydraulic Hand Dynamometer". The patient's measurements were carried out in two positions. While the patient was in a sitting position, measurements were made in shoulder adduction, elbow 90˚ flexion, forearm in neutral position, wrist in 0-30˚ extension and 0-15˚ in ulnar deviation position. While the patient was standing, measurement was performed with shoulder adduction, elbow extension, forearm in neutral position. For maximum grip, patients should be able to hold the dynamometer for a maximum of 3 seconds. it was said to tighten with all its might. Measurements were repeated 3 times at 30-second intervals on the affected limb, and the measurements were averaged. Values are noted in kilograms (kg) - force
Change from baseline in Pain Score at 6 weeks
Time frame: Baseline and 4 weeks
Visual Analogue Scale was used to determine the severity of rest, activity and night pain in patients with lateral epicondylitis. Patients were asked to mark their pain levels on a 10 cm scale before starting treatment and after 4 weeks of treatment. The value "0" means that there is no pain, and the value "10" means unbearable pain. The marked points are measured and recorded in centimeters
1 secondary outcome
Change from baseline in Functionality at 6 weeks
Time frame: Baseline and 4 weeks
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 8 Sep 2021.
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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 Sönmez ÜNÜVAR principal investigator
KTO Karatay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulligan Technique and Muscle Energy Technique in people with Tennis Elbow, run by KTO Karatay 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 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 8 Sep 2021. 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?
Change from baseline in Hand Grip Strenght at 6 weeks (time frame: Baseline and 4 weeks). The study lists 2 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 8 Sep 2021.