Lateral Epicondylitis (Tennis Elbow)NCT06965985
Comparison of the Effectiveness of Mulligan Mobilization and Myofascial Release Technique in Patients With Lateral Epicondylitis
A study testing Mulligan mobilization therapy, Myofascial release therapy and Exercise Therapy in people with Lateral Epicondylitis (Tennis Elbow), run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Lateral epicondylitis (LE), recognized as one of the most prevalent causes of elbow pain, has an estimated incidence ranging from 1% to 3%. It most commonly presents in individuals between the ages of 40 and 50 and tends to affect the dominant limb more frequently. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis (Tennis Elbow)
- What is being tested?
- Mulligan mobilization therapy, Myofascial release therapy and Exercise Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged between 18 and 65 years
- Diagnosed with unilateral lateral epicondylitis (LE)
Who cannot join
- Younger than 18 or older than 65 years
- Communication difficulties
- History of injection, surgery, or physical therapy in the elbow region within the past 6 months
- Pain originating from the cervical spine (e.g., radiculopathy, spinal stenosis), shoulder problems, or other elbow pathologies unrelated to LE
- History of elbow osteoarthritis or previous elbow fracture
- History of polyneuropathy
Show all 14Show fewer
- Uncontrolled systemic diseases (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic disorders)
- Uncontrolled systemic endocrine disorders (e.g., diabetes mellitus, hyperthyroidism)
- History of major psychiatric disorders
- History of rheumatic diseases such as fibromyalgia, polymyalgia rheumatica, ankylosing spondylitis, or rheumatoid arthritis
- Presence of bleeding disorders or use of anticoagulant medications
- Neurological deficits
- Posterior interosseous nerve (PIN) syndrome
- Current or past use of wrist resting splints or elbow braces
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Konya Beyhekim Eğitim ve Araştırma Hastanesi
Konya, Selçuklu, 42060
About this study
Lateral epicondylitis (LE), recognized as one of the most prevalent causes of elbow pain, has an estimated incidence ranging from 1% to 3%. It most commonly presents in individuals between the ages of 40 and 50 and tends to affect the dominant limb more frequently. In the adult population, LE is the leading cause of lateral elbow pain.
To date, more than 40 different treatment modalities have been described for the management of LE, primarily aiming to alleviate pain and enhance functional outcomes.
However, a universally accepted standard treatment has yet to be established. The objective of this thesis is to compare the clinical effectiveness of the Mulligan mobilization technique and the myofascial release technique-both commonly utilized in the treatment of LE-through a prospective clinical study.
Read the detailed description
The study is designed as a prospective, case-control, hospital-based investigation. A total of 114 patients between the ages of 18 and 65, presenting to our clinic with elbow pain and diagnosed with lateral epicondylitis (LE) based on physical examination findings-including tenderness upon palpation of the lateral epicondyle, pain during resisted wrist extension, and discomfort during stretching of the wrist extensors-will be included in the study. All participants must have experienced elbow pain for at least three months. The diagnosis of LE will be established according to clinical criteria. Specifically, LE will be diagnosed if pain is elicited upon resisted wrist extension, stretching of the wrist extensor muscles, and palpation over the lateral epicondyle of the humerus.
Participants will be fully informed about the procedure, and written informed consent will be obtained.
The study will be conducted in accordance with the principles outlined in the Declaration of Helsinki.
A comprehensive medical history will be obtained from all participants, along with a detailed physical examination.
Sociodemographic and clinical data-including age, sex, height, weight, education level, employment status, and income level-will be collected through standardized questionnaires.A total of 114 patients diagnosed with lateral epicondylitis (LE) will be randomly assigned into three groups.
Group 1 (n=38) will receive Mulligan mobilization therapy three times per week for four weeks (a total of 12 sessions), along with a home exercise program.
Group 2 (n=38) will receive myofascial release therapy three times per week for four weeks (a total of 12 sessions), in combination with a home exercise program.
Group 3 (n=38) will receive only a home exercise program, administered three times per week over four weeks (a total of 12 sessions).
All patients will be evaluated at three time points: before treatment, immediately after the completion of the treatment, and one month post-treatment.
During the evaluation process, the following assessments will be performed:
Maximum hand grip strength, measured using a Jamar dynamometer [17].
Pain intensity and localization, assessed using a 0-10 point Visual Analog Scale (VAS) during maximum grip effort and at rest.
Functional disability, measured using the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire [18].
Pain and functional assessment of the arm over the past week, evaluated with the Patient-Rated Tennis Elbow Evaluation (PRTEE/PRFEQ) [19].
Patient satisfaction with treatment, assessed by the Modified Roles and Maudsley Score (Roles NC-32).
Quality of life, measured using the Short Form-36 (SF-36) questionnaire [20].
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Being tested
- Mulligan mobilization therapy, Myofascial release therapy, Exercise Therapy
- Keywords
- Lateral Epicondylitis, Mobilization Techniques, Myofascial Release, Exercise Therapy
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan mobilization therapyOther
While the mobilization belt is placed around the patient's proximal forearm and looped over the therapist's shoulder, the distal humerus will be stabilized with one hand. A lateral glide will be applied to the forearm through the belt and maintained for approximately 5 to 10 seconds. The patient will perform repeated wrist extensions against the manual resistance provided by the therapist's hand. Once a pain-free wrist extension is achieved, the lateral glide will be released. A total of 6 repetitions will be performed with 15-second rest intervals between repetitions. This protocol will be applied three times per week for two weeks.
Myofascial release therapyOther
The patient will be placed in a supine position with the shoulder internally rotated, the elbow in pronation and approximately 15 degrees of flexion, and the palm resting flat on the table. The therapist will stand beside the table at the level of the patient, facing the patient's ipsilateral arm and shoulder. The treatment will be administered for 10 minutes, three sessions per week for two weeks.
The therapist will begin the treatment from just proximal to the lateral epicondyle, on the humerus, and proceed distally along the path of the common extensor tendon to the extensor retinaculum of the wrist. Using the fingertips, the therapist will engage the periosteum and maintain contact as the technique continues along the common extensor tendon and further distally along the extensor retinaculum of the wrist.
Exercise TherapyOther
All patients will be provided with a home exercise program consisting of eccentric strengthening exercises targeting the wrist extensors, with resistance gradually increased each week. Patients will be instructed in strengthening exercises for the wrist extensors as well as forearm pronation and supination. The home program will consist of 3 sets of 10 repetitions per day.
The exercises will be demonstrated in person by the physician, and each patient will receive a printed handout detailing how to perform the exercises. During weekly treatment sessions and after the treatment period, patients will be contacted by phone to assess adherence to the exercise program and to reinforce the importance of compliance.
Patients with exercise compliance below 75-80% will be excluded from the study.
| Study group | Role | What they receive |
|---|---|---|
| Mulligan mobilization techniqu | Experimental | Will receive Mulligan mobilization therapy three times per week for four weeks (a total of 12 sessions), along with a home exercise program Receives: Other: Mulligan mobilization therapy |
| Myofascial release therapy | Experimental | will receive myofascial release therapy three times per week for four weeks (a total of 12 sessions), in combination with a home exercise program. Receives: Other: Myofascial release therapy |
| Exercise Therapy | Active comparator | Will follow only the home exercise program, three times per week for four weeks (12 sessions total). Receives: Other: Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain (0-10)
0 no pain; 10 unbearable/max. pain
Measured: baseline, week 4 and week 8
grip strength
using a Jamar® dynamometer (in kilograms)
Measured: baseline, week 4 and week 8
Secondary outcomes (4)
The Disabilities of the Arm, Shoulder, and Hand (DASH)
0 (best condition) to 100 (worst condition)
Measured: baseline, week 4 and week 8
Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)
0 (best) to 100 (worst)
Measured: baseline, week 4 and week 8
The Short Form-36 (SF-36) quality of life index
0, indicating the worst health status, to 100, representing the best possible health
Measured: baseline, week 4 and week 8
Patient satisfaction/benefit scale (The Roles and Maudsley score)
The Roles and Maudsley score was utilized to evaluate pain and activity limitations in the assessment of treatment efficacy, categorized into four levels: 1 point indicating excellent, 2 points indicating good, 3 points indicating fair, and 4 points indicating poor.
Measured: week 4 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Jan 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Epicondylitis (Tennis Elbow)Studies 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
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965985
- Sponsor's protocol ID
- KonyaBeyhekimTRH2023/4512
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Mulligan Mobilization and Myofascial Release Technique in Patients With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT06965985
- Acronym / sponsor ID
- KonyaBeyhekimTRH2023/4512
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Keywords
- Lateral Epicondylitis, Mobilization Techniques, Myofascial Release, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 11 May 2025 (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 (LE), recognized as one of the most prevalent causes of elbow pain, has an estimated incidence ranging from 1% to 3%. It most commonly presents in individuals between the ages of 40 and 50 and tends to affect the dominant limb more frequently. In the adult population, LE is the leading cause of lateral elbow pain.
To date, more than 40 different treatment modalities have been described for the management of LE, primarily aiming to alleviate pain and enhance functional outcomes.
However, a universally accepted standard treatment has yet to be established. The objective of this thesis is to compare the clinical effectiveness of the Mulligan mobilization technique and the myofascial release technique-both commonly utilized in the treatment of LE-through a prospective clinical study.
Detailed description
The study is designed as a prospective, case-control, hospital-based investigation. A total of 114 patients between the ages of 18 and 65, presenting to our clinic with elbow pain and diagnosed with lateral epicondylitis (LE) based on physical examination findings-including tenderness upon palpation of the lateral epicondyle, pain during resisted wrist extension, and discomfort during stretching of the wrist extensors-will be included in the study. All participants must have experienced elbow pain for at least three months. The diagnosis of LE will be established according to clinical criteria. Specifically, LE will be diagnosed if pain is elicited upon resisted wrist extension, stretching of the wrist extensor muscles, and palpation over the lateral epicondyle of the humerus.
Participants will be fully informed about the procedure, and written informed consent will be obtained.
The study will be conducted in accordance with the principles outlined in the Declaration of Helsinki.
A comprehensive medical history will be obtained from all participants, along with a detailed physical examination.
Sociodemographic and clinical data-including age, sex, height, weight, education level, employment status, and income level-will be collected through standardized questionnaires.A total of 114 patients diagnosed with lateral epicondylitis (LE) will be randomly assigned into three groups.
Group 1 (n=38) will receive Mulligan mobilization therapy three times per week for four weeks (a total of 12 sessions), along with a home exercise program.
Group 2 (n=38) will receive myofascial release therapy three times per week for four weeks (a total of 12 sessions), in combination with a home exercise program.
Group 3 (n=38) will receive only a home exercise program, administered three times per week over four weeks (a total of 12 sessions).
All patients will be evaluated at three time points: before treatment, immediately after the completion of the treatment, and one month post-treatment.
During the evaluation process, the following assessments will be performed:
Maximum hand grip strength, measured using a Jamar dynamometer [17].
Pain intensity and localization, assessed using a 0-10 point Visual Analog Scale (VAS) during maximum grip effort and at rest.
Functional disability, measured using the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire [18].
Pain and functional assessment of the arm over the past week, evaluated with the Patient-Rated Tennis Elbow Evaluation (PRTEE/PRFEQ) [19].
Patient satisfaction with treatment, assessed by the Modified Roles and Maudsley Score (Roles NC-32).
Quality of life, measured using the Short Form-36 (SF-36) questionnaire [20].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mulligan mobilization techniqu | Experimental | Other: Mulligan mobilization therapyWill receive Mulligan mobilization therapy three times per week for four weeks (a total of 12 sessions), along with a home exercise program |
| Myofascial release therapy | Experimental | Other: Myofascial release therapywill receive myofascial release therapy three times per week for four weeks (a total of 12 sessions), in combination with a home exercise program. |
| Exercise Therapy | Active comparator | Other: Exercise TherapyWill follow only the home exercise program, three times per week for four weeks (12 sessions total). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged between 18 and 65 years
- Diagnosed with unilateral lateral epicondylitis (LE)
Key exclusion criteria (14 listed)
- Younger than 18 or older than 65 years
- Communication difficulties
- History of injection, surgery, or physical therapy in the elbow region within the past 6 months
- Pain originating from the cervical spine (e.g., radiculopathy, spinal stenosis), shoulder problems, or other elbow pathologies unrelated to LE
- History of elbow osteoarthritis or previous elbow fracture
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 mobilization therapyWhile the mobilization belt is placed around the patient's proximal forearm and looped over the therapist's shoulder, the distal humerus will be stabilized with one hand. A lateral glide will be applied to the forearm through the belt and maintained for approximately 5 to 10 seconds. The patient will perform repeated wrist extensions against the manual resistance provided by the therapist's hand. Once a pain-free wrist extension is achieved, the lateral glide will be released. A total of 6 repetitions will be performed with 15-second rest intervals between repetitions. This protocol will be applied three times per week for two weeks. | Other | Mulligan mobilization techniqu |
| Myofascial release therapyThe patient will be placed in a supine position with the shoulder internally rotated, the elbow in pronation and approximately 15 degrees of flexion, and the palm resting flat on the table. The therapist will stand beside the table at the level of the patient, facing the patient's ipsilateral arm and shoulder. The treatment will be administered for 10 minutes, three sessions per week for two weeks. The therapist will begin the treatment from just proximal to the lateral epicondyle, on the humerus, and proceed distally along the path of the common extensor tendon to the extensor retinaculum of the wrist. Using the fingertips, the therapist will engage the periosteum and maintain contact as the technique continues along the common extensor tendon and further distally along the extensor retinaculum of the wrist. | Other | Myofascial release therapy |
| Exercise TherapyAll patients will be provided with a home exercise program consisting of eccentric strengthening exercises targeting the wrist extensors, with resistance gradually increased each week. Patients will be instructed in strengthening exercises for the wrist extensors as well as forearm pronation and supination. The home program will consist of 3 sets of 10 repetitions per day. The exercises will be demonstrated in person by the physician, and each patient will receive a printed handout detailing how to perform the exercises. During weekly treatment sessions and after the treatment period, patients will be contacted by phone to assess adherence to the exercise program and to reinforce the importance of compliance. Patients with exercise compliance below 75-80% will be excluded from the study. | Other | Exercise Therapy |
Primary outcome
VAS pain (0-10)
Time frame: baseline, week 4 and week 8
0 no pain; 10 unbearable/max. pain
grip strength
Time frame: baseline, week 4 and week 8
using a Jamar® dynamometer (in kilograms)
4 secondary outcomes
The Disabilities of the Arm, Shoulder, and Hand (DASH)
Time frame: baseline, week 4 and week 8
Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)
Time frame: baseline, week 4 and week 8
The Short Form-36 (SF-36) quality of life index
Time frame: baseline, week 4 and week 8
Patient satisfaction/benefit scale (The Roles and Maudsley score)
Time frame: week 4 and week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Lateral Epicondylitis (Tennis Elbow)
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
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.
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 mobilization therapy, Myofascial release therapy and Exercise Therapy in people with Lateral Epicondylitis (Tennis Elbow), run by Konya Beyhekim Training and Research Hospital 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 2 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 11 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cansu Ertuğrul (+905373328271, cansuertugrl@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain (0-10) (time frame: baseline, week 4 and week 8). 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 11 May 2025.