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IRCT20190315043058N1 IRCT 2019-04-26 Iran University of Medical Sciences The effect of Mulligan's techniques in the treatment of chronic lateral epicondylitis The effect of Mulligan's techniques along with routine physiotherapy,‎ in comparison with routine physiotherapy alone; on pain, grip strength, and function in patients diagnosed with chronic lateral epicondylitis 2019-04-19 anticipated 34 Complete https://irct.ir/trial/38410 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is a single-blind randomised controlled clinical trial with continuous non-random and purposive (subjective) sampling. The study is at Level Ib, which is the highest level of clinical trials in the Evidence-Based Medicine (EBM) pyramid, Randomization description: Participants are randomly assigned to either the routine group of physiotherapy or the Mulligan group using the Web application Randomizer (www.randomizer.org, version 4), Blinding description: This is a single-blind study. In a single-blind study, only the therapist and assessor are aware of the make up of the treatment groups and the participants are unaware of the the treatment group they are assigned to. N/A Chronic Lateral Epicondylitis. Intervention 1: Control group: A total of 34 patients are enrolled in this study. The control group consists of 17 patients who receive routine treatment for 12 sessions in 4 weeks. In the current study, the routine treatment includes ultrasound, strengthening and stretching exercises. Patients in this group receive ultrasound with a frequency of 3 Mhz and intensity of 1.5 w/cm2 in pulsed mode of operation and the pulse is 1ms on and 5ms off. The area of the transducer head is 4 square centimeters (4cm2). The transducer head is placed on the junction of the extensor carpi radialis brevis tendon for 5 minutes. The strengthening exercises are in the form of eccentric strengthening exercises. In the early sessions, exercises are carried out with low-load and high-repetition. Three principles are taken into account in strengthening exercises: the exercise load intensity, the speed, and the frequency of exercises. The exercise load intensity and the speed of strengthening exercises are adjusted according to the symptoms severity of the patients in various treatment sessions. However, The frequency of exercises is three sets of ten repetitions per session. The strengthening exercises are performed with the patient's elbow in the extension and the forearm in the pronation, while the physiotherapist moves the patient's wrist in the flexion direction and the patient resists against the movement using eccentric contraction. Passive and static stretching exercises are performed by an expert physiotherapist with more than 15 years of experience in the treatment of patients with chronic lateral epicondylitis. To perform the exercises, the patient's elbow is placed in the extension and the forearm in the pronation. The physiotherapist flexes the patient's wrist passively and holds it for 30 - 45 seconds. The number of repetitive stretching exercises is set to six repetitions, with a 15 second rest interval between two stretching exercises; based on the Fyfe and Stanish study. Intervention 2: Intervention group: The intervention group (the Mulligan treatment group) consists of 17 patients. The Mulligan treatment group receives the routine treatment along with Mulligan's techniques. Patients receive two Mulligan's techniques in the extension and flexion positions. Mulligan's technique in the extension position: To perform the Mulligan's technique, the patients are placed in the supine position with their elbow in the extension and their forearm in the pronation, so that the radiohumeral joint is perpendicular to the ground. The Mulligan belt passes under the articular surface of the elbow joint and around the radiohumeral joint and wraps around the physiotherapist’s shoulder. The physiotherapist stabilises the distal part of the forearm on the bed with one hand and holds the distal part of the humerus bone in a fixed position, with the other hand. Simultaneously, the therapist applies an upward force, perpendicular to the ground by lifting up on the forefoot. While applying the force, the patients are asked to make a full fist to the maximum strength. The force is applied for 6 seconds and then the patients are asked to release their fingers. This technique is applied 10 times and while it is applied, no pain should be reported by the patient. Mulligan's technique in the flexion position: To perform this technique, the patient is placed in the supine position. The patient's elbow is flexed at 90 degree, and the Mulligan belt passes under the proximal forearm of the patient and wraps around the pelvis of the physiotherapist. The physiotherapist stabilises the distal part of the forearm on the bed with one hand and holds the distal part of the humerus bone in a fixed position with the other hand to prevent the movement of different parts, while applying the technique. Then the physiotherapist applies a downward force to the proximal forearm by moving his pelvis backwards. The duration of the force is 6 seconds and the technique is applied 10 times. Care should be taken so that the patient does not report any increase in pain, during the application of the technique. Yes - There is a plan to make this available What will be shared: Data collected for the primary and secondary outcome measures is shared after anonymising participants, if required. When: The data is accessible 6 months after publishing the outcomes of the study. To whom: The data is accessible to physical therapists working in academic institutions as well as clinicians working in the field of musculoskeletal disorders. Conditions: The raw data and the results of this study might be used in the future relevant research studies and systematic reviews. Hence, the raw data and the results of this study are accessible to researchers working in the field of elbow lesions. Where to obtain: Please send your access requests to Mohammad Asadi (PT, MSc student). Email address: ptdrasadi@gmail.com How to obtain: Researchers should describe their project in detail and explain how the data/documents of this study will be used in their project. Following the request, the data/document files will be sent to researchers by email. This process might take 10 - 12 working days. Comments:
public Mohammad Asadi
4th Floor, No. 17, Mobarez Allay, Tous Street, Tehran
Tehran Iran (Islamic Republic of) 1341853347 +98 21 6608 1222 ptdrasadi@gmail.com Iran University of Medical Sciences scientific Ismail Ebrahimi Takamjani
No. 195, Khalili Alley, Saba Blvd., Rumi Bridge, Shariati Street, Tehran
Tehran Iran (Islamic Republic of) 1998135353 +98 21 2239 2426 Ebrahimitakamjani.e@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients with chronic lateral epicondylitis symptoms lasting more than 3 months, with an average age of 35 - 55 years who are referred by the physician Pain intensity of at least 3, in the lateral epicondyle of the humerus bone, which demonstrates an increase of 2 units by griping and active wrist extension, and decreases with rest. Pain intensity is assessed using numeric pain rating scale (NPRS) measure Positive Mill’s test (passive stretching): The physiotherapist touches the lateral epicondyle with one hand, while with the other hand pronates the patient's forearm and flexes the wrist to the maximum flexion and extends the elbow. Reproduction of pain indicates that the test is positive Positive Cozen's test (wrist resistive extension test): The wrist resistive extension and radial deviation and forearm pronation tests are performed. In case the test triggers pain, the test is considered positive Positive Maudsley's test: A positive test is indicated by presence of pain over the lateral epicondyle of the affected hand during the third finger resistive extension test Presence of tenderness at the tenoperiosteal junction or at the junction of the extensor carpi radialis brevis muscle to the lateral humeral epicondyle 35 years 55 years Both Pain in the lateral humeral epicondyle, due to neck involvement Lateral humeral epicondyle acute inflammation Pain in the lateral humeral epicondyle, caused by acute trauma of elbow region Radial tunnel syndrome Elbow joint inflammation Injuries to the internal and external ligaments of the elbow Medial humeral epicondylitis History of elbow joint bone fractures Presence of deformity or congenital anomalies of the elbow joint Pregnancy Infection of the elbow joint Malignancies Hemophilia Generalised hypermobility Presence of swelling in the elbow joint Presence of myositis ossification in radiographic x-ray Dissatisfaction of participants Trigger points in the wrist and finger extensor muscles Rehabilitation Rehabilitation Control group: A total of 34 patients are enrolled in this study. The control group consists of 17 patients who receive routine treatment for 12 sessions in 4 weeks. In the current study, the routine treatment includes ultrasound, strengthening and stretching exercises. Patients in this group receive ultrasound with a frequency of 3 Mhz and intensity of 1.5 w/cm2 in pulsed mode of operation and the pulse is 1ms on and 5ms off. The area of the transducer head is 4 square centimeters (4cm2). The transducer head is placed on the junction of the extensor carpi radialis brevis tendon for 5 minutes. The strengthening exercises are in the form of eccentric strengthening exercises. In the early sessions, exercises are carried out with low-load and high-repetition. Three principles are taken into account in strengthening exercises: the exercise load intensity, the speed, and the frequency of exercises. The exercise load intensity and the speed of strengthening exercises are adjusted according to the symptoms severity of the patients in various treatment sessions. However, The frequency of exercises is three sets of ten repetitions per session. The strengthening exercises are performed with the patient's elbow in the extension and the forearm in the pronation, while the physiotherapist moves the patient's wrist in the flexion direction and the patient resists against the movement using eccentric contraction. Passive and static stretching exercises are performed by an expert physiotherapist with more than 15 years of experience in the treatment of patients with chronic lateral epicondylitis. To perform the exercises, the patient's elbow is placed in the extension and the forearm in the pronation. The physiotherapist flexes the patient's wrist passively and holds it for 30 - 45 seconds. The number of repetitive stretching exercises is set to six repetitions, with a 15 second rest interval between two stretching exercises; based on the Fyfe and Stanish study. Intervention group: The intervention group (the Mulligan treatment group) consists of 17 patients. The Mulligan treatment group receives the routine treatment along with Mulligan's techniques. Patients receive two Mulligan's techniques in the extension and flexion positions. Mulligan's technique in the extension position: To perform the Mulligan's technique, the patients are placed in the supine position with their elbow in the extension and their forearm in the pronation, so that the radiohumeral joint is perpendicular to the ground. The Mulligan belt passes under the articular surface of the elbow joint and around the radiohumeral joint and wraps around the physiotherapist’s shoulder. The physiotherapist stabilises the distal part of the forearm on the bed with one hand and holds the distal part of the humerus bone in a fixed position, with the other hand. Simultaneously, the therapist applies an upward force, perpendicular to the ground by lifting up on the forefoot. While applying the force, the patients are asked to make a full fist to the maximum strength. The force is applied for 6 seconds and then the patients are asked to release their fingers. This technique is applied 10 times and while it is applied, no pain should be reported by the patient. Mulligan's technique in the flexion position: To perform this technique, the patient is placed in the supine position. The patient's elbow is flexed at 90 degree, and the Mulligan belt passes under the proximal forearm of the patient and wraps around the pelvis of the physiotherapist. The physiotherapist stabilises the distal part of the forearm on the bed with one hand and holds the distal part of the humerus bone in a fixed position with the other hand to prevent the movement of different parts, while applying the technique. Then the physiotherapist applies a downward force to the proximal forearm by moving his pelvis backwards. The duration of the force is 6 seconds and the technique is applied 10 times. Care should be taken so that the patient does not report any increase in pain, during the application of the technique. Pain. Timepoint: The outcomes of the study will be measured at baseline and after 12 sessions of treatment and the results of the two groups will be compared. Method of measurement: In this study, a 100 mm Numeric Pain Rating Scale (100 mm NPRS) is used to measure pain. The patients are asked to place a mark along a 100-mm scale to indicate the average elbow pain they had suffered in the last 24 hours while resting. Functional Disability. Timepoint: The outcomes of the study will be measured at baseline and after 12 sessions of treatment and the results of the two groups will be compared. Method of measurement: In order to evaluate the functional status of participants, a Persian version of the Patient-Rated Elbow Evaluation Questionnaire is used. The questionnaire contains 5 questions about pain domain and 15 questions about functional limitations domain during everyday life, work and exercise. Grip Strength. Timepoint: The outcomes of the study will be measured at baseline and after 12 sessions of treatment and the results of the two groups will be compared. Method of measurement: Maximum grip strength is evaluated using the SHE 1001 SAEHAN handheld digital hydraulic dynamometer. . Timepoint: . Method of measurement: . The current study is fully funded by Mohammad Asadi. Approved 2018-10-02 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences Campus, Hemmat Highway, Next to Milad tower Tehran Tehran Iran (Islamic Republic of)