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Combined Shockwave Therapy Versus Focused Shockwave Therapy in Patients With Lateral Epicondylitis

Primary Purpose

Epicondylitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapy
Sponsored by
Mennallah Ahmed Mohamed Anwar Elgendy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epicondylitis focused on measuring Shockwave therapy, Lateral epicondylitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patient age between 18 - 55 years old. BMI < 35 Males and Females Painful chronic tennis elbow during at least 3 previous months identified by positive Mill"s, Maudsley"s and Cozen"s tests. Painful palpation of the lateral epicondyle. Painful resisted middle finger and wrist extension (Maudsley's test). Exclusion Criteria: Local infection. Malignancy. Elbow arthritis or instability. Pronator-Teres syndrome. Generalized polyarthritis. Neurological disorders (Stroke and Parkinson"s disease). Radial-nerve entrapment. Physical therapy and/or a corticosteroid injection administered within the previous six weeks. Pregnancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Group A

    Group B

    Group C

    Arm Description

    Group (1): Twenty patients will receive 2000 pulses of Focused shock wave therapy with (4 Hz; 0.2 millijoule (mJ)/mm2) in addition to conventional therapy including eccentric exercises, stretching, hot packs and deep transverse friction(Johnson et al., 2007). Each patient will have 3 treatment sessions held at weekly basis(Król et al., 2015).

    Group (2): Twenty patients will receive both 2000 pulses of (Focused shockwave therapy with (4 Hz; 0.2 mJ/mm2) and 2000 pulses of Radial shockwave therapy with (8 Hz, 2.5 bars) )= combined shockwave therapy in addition to conventional therapy including eccentric exercises, stretching, hot packs and deep transverse friction(Johnson et al., 2007). Each patient will have 3 treatment sessions held at weekly basis(Król et al., 2015).

    Group (3): Control group of twenty patients that will only receive conventional therapy including eccentric exercises, stretching, hot packs and deep transverse friction(Johnson et al., 2007).

    Outcomes

    Primary Outcome Measures

    Visual analog Scale (VAS) for pain to will be carried out for each patient individually before, immediately after treatment and 2 months after end of treatment.
    amount of pain the VAS scale will be employed, where 0 indicates "no pain" and 10 indicates "most severe pain
    rated-tennis-elbow-questionnaire for hand function assessment
    score from that questionnaire Pain Subscale - Add up 5 items. Best score = 0; Worst score = 50 Specific Activities - Add up 6 items Best Score = 0; Worst Score = 60 Usual Activities - Add up 4 items items Best Score = 0; Worst Score = 40 Function Subscale - (Specific Activities + Usual Activities) /2 Best score = 0; Worst score = 50 Total Score = Pain Subscale + Function Subscale Best Score = 0; Worst Score = 100 (pain and disability contribute equally to score)
    Grip strength will be measured using the CAMRY digital hand dynamometer, model EH101
    Device used to test the hand grib strength

    Secondary Outcome Measures

    For patient selection Mill's Test
    Patient's lateral epicondyle palpated with one hand, while pronating the patient's forearm, fully flexing the wrist, the elbow extended. Decided it a positive test when we found pain in the area of insertion at lateral epicondyle.
    Maudsley's test
    The examiner resists extension of the 3rd digit of the hand, stressing the extensor digitorum muscle and tendon, while palpating the patient's lateral epicondyle. A positive test is indicated by pain over the lateral epicondyle of the humerus.
    Cozen's Test
    To perform Cozen's test,patient seated, the therapist stabilizes the patient's elbow in 90 degrees of flexion with one hand while palpating over the lateral epicondyle. The other hand positions the patient's hand into radial deviation and forearm pronation while the patient is asked to resisted wrist extension in this position against manual resistance of the therapist. The test is considered positive if it produces pain or reproduction of other symptoms in the area of the lateral epicondyle.

    Full Information

    First Posted
    March 26, 2023
    Last Updated
    August 13, 2023
    Sponsor
    Mennallah Ahmed Mohamed Anwar Elgendy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05853029
    Brief Title
    Combined Shockwave Therapy Versus Focused Shockwave Therapy in Patients With Lateral Epicondylitis
    Official Title
    Combined Shockwave Therapy Versus Focused Shockwave Therapy in Patients With Lateral Epicondylitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    January 2024 (Anticipated)
    Study Completion Date
    February 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mennallah Ahmed Mohamed Anwar Elgendy

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To determine the best effective modality between combined (focused and radial) and focused shockwave therapy for treatment of lateral epicondylitis regarding pain. To determine the best effective modality between combined (focused and radial) and focused shockwave therapy for treatment of lateral epicondylitis regarding hand function. 1. To determine the best effective modality between combined (focused and radial) and focused shockwave therapy for treatment of lateral epicondylitis regarding grip strength.
    Detailed Description
    Lateral epicondylitis, also known as "tennis elbow", is a common disease present in clinical practice. It affects 1% to 3% in the general population which can reach up to 29% in certain occupations with repetitive wrist movements. It can cause a significant functional decline with a great psychological and economic impact. Major symptoms include decreased grip and upper-extremity strength along with pain and inflammation originating from the lateral elbow. The pathogenesis of lateral epicondylitis is still controversial, but it is known that not only the tendon of the extensor carpi radialis brevis (ECRB) muscle but also the annular ligament, lateral capsule, radial nerve and some bands of the extensor digitorum communis muscle are involved. It was originally thought that the cause of lateral epicondylitis was an inflammatory process, which would then result in the symptoms. However, histological studies have demonstrated that, through repetitive injuries at this site, there is a degenerative process and a failure of repair in the ECRB tendon. This is more pronounced than inflammation in other structures. A variety of therapeutic techniques have been proposed for the appropriate management of patients with lateral elbow tendinopathy including exercise, orthotics, manual therapy, passive modalities, acupuncture or a combination of them. However, the effectiveness of each treatment option remains debatable. Extracorporeal shockwave therapy (ESWT) is a popular method in the management of common tendinopathies and has been proposed as an effective supplement to other non-invasive therapies. There are two types of extracorporeal shockwave therapy: focused shockwave therapy (FSWT) and radial shockwave therapy (RSWT). Waves that are generated for focused and radial ESWT have very different physical characteristics. FSWT has focused on a pressure area concentrated on a definite place, and can be adjusted at definite depths in the selected tissues, where the higher pressure is touched. Focused type of shockwave is directed by the reflection at definitive areas into the body of patients, and the waves are generated from a wide arc, hence the amount of energy discrete is minimal at the point of real wave generation. The radial shock wave therapy has been attributed to the scattering pressure zone of RSWT apparatus, which arrives at the source as the highest pressure, and didn't require a certain distance in human body and the omitted waves radiate within the tissues, and influence a large area, but they do not deeply reach the thick tissues as that in focused wave therapy, therefore RSWT is effective for treating superficial lesions that assist the deep-tissue stimulation like backs and muscles.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epicondylitis
    Keywords
    Shockwave therapy, Lateral epicondylitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Masking Description
    Randomization using envelop
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    Group (1): Twenty patients will receive 2000 pulses of Focused shock wave therapy with (4 Hz; 0.2 millijoule (mJ)/mm2) in addition to conventional therapy including eccentric exercises, stretching, hot packs and deep transverse friction(Johnson et al., 2007). Each patient will have 3 treatment sessions held at weekly basis(Król et al., 2015).
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    Group (2): Twenty patients will receive both 2000 pulses of (Focused shockwave therapy with (4 Hz; 0.2 mJ/mm2) and 2000 pulses of Radial shockwave therapy with (8 Hz, 2.5 bars) )= combined shockwave therapy in addition to conventional therapy including eccentric exercises, stretching, hot packs and deep transverse friction(Johnson et al., 2007). Each patient will have 3 treatment sessions held at weekly basis(Król et al., 2015).
    Arm Title
    Group C
    Arm Type
    Experimental
    Arm Description
    Group (3): Control group of twenty patients that will only receive conventional therapy including eccentric exercises, stretching, hot packs and deep transverse friction(Johnson et al., 2007).
    Intervention Type
    Combination Product
    Intervention Name(s)
    Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapy
    Other Intervention Name(s)
    Conventional therapy for tennis elbow
    Intervention Description
    The device used for management is from Storz-Medical company; Duolith-SD1 with focused and radial module. - Conventional therapy in the form of eccentric exercises, stretching, hot packs and deep transverse friction(Johnson et al., 2007).
    Primary Outcome Measure Information:
    Title
    Visual analog Scale (VAS) for pain to will be carried out for each patient individually before, immediately after treatment and 2 months after end of treatment.
    Description
    amount of pain the VAS scale will be employed, where 0 indicates "no pain" and 10 indicates "most severe pain
    Time Frame
    3 months
    Title
    rated-tennis-elbow-questionnaire for hand function assessment
    Description
    score from that questionnaire Pain Subscale - Add up 5 items. Best score = 0; Worst score = 50 Specific Activities - Add up 6 items Best Score = 0; Worst Score = 60 Usual Activities - Add up 4 items items Best Score = 0; Worst Score = 40 Function Subscale - (Specific Activities + Usual Activities) /2 Best score = 0; Worst score = 50 Total Score = Pain Subscale + Function Subscale Best Score = 0; Worst Score = 100 (pain and disability contribute equally to score)
    Time Frame
    3 months
    Title
    Grip strength will be measured using the CAMRY digital hand dynamometer, model EH101
    Description
    Device used to test the hand grib strength
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    For patient selection Mill's Test
    Description
    Patient's lateral epicondyle palpated with one hand, while pronating the patient's forearm, fully flexing the wrist, the elbow extended. Decided it a positive test when we found pain in the area of insertion at lateral epicondyle.
    Time Frame
    Before the study for patient selection
    Title
    Maudsley's test
    Description
    The examiner resists extension of the 3rd digit of the hand, stressing the extensor digitorum muscle and tendon, while palpating the patient's lateral epicondyle. A positive test is indicated by pain over the lateral epicondyle of the humerus.
    Time Frame
    Before the study for patient selection
    Title
    Cozen's Test
    Description
    To perform Cozen's test,patient seated, the therapist stabilizes the patient's elbow in 90 degrees of flexion with one hand while palpating over the lateral epicondyle. The other hand positions the patient's hand into radial deviation and forearm pronation while the patient is asked to resisted wrist extension in this position against manual resistance of the therapist. The test is considered positive if it produces pain or reproduction of other symptoms in the area of the lateral epicondyle.
    Time Frame
    Before the study for patient selection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patient age between 18 - 55 years old. BMI < 35 Males and Females Painful chronic tennis elbow during at least 3 previous months identified by positive Mill"s, Maudsley"s and Cozen"s tests. Painful palpation of the lateral epicondyle. Painful resisted middle finger and wrist extension (Maudsley's test). Exclusion Criteria: Local infection. Malignancy. Elbow arthritis or instability. Pronator-Teres syndrome. Generalized polyarthritis. Neurological disorders (Stroke and Parkinson"s disease). Radial-nerve entrapment. Physical therapy and/or a corticosteroid injection administered within the previous six weeks. Pregnancy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Menna allah Elgendy, Bachelor
    Phone
    01010334319
    Email
    Mennaallahelgendy@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    NEVEEN Abdelraoof, Prof. Dr
    Phone
    +20 106 4615553
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    RANIA REDA, A. Prof Dr.
    Organizational Affiliation
    cairo uni
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    NEVEEN Abdelraoof, Prof. Dr.
    Organizational Affiliation
    cairo uni
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Menna allah Elgendy, Bachelor
    Organizational Affiliation
    cairo uni
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Titus Bertolini, Dr. med.
    Organizational Affiliation
    Medicum clinics Germany
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Combined Shockwave Therapy Versus Focused Shockwave Therapy in Patients With Lateral Epicondylitis

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