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

Sponsor
Mennallah Ahmed Mohamed Anwar Elgendy (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05853029
Collaborator
(none)
60
Enrollment
3
Arms
9.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

  1. To determine the best effective modality between combined (focused and radial) and focused shockwave therapy for treatment of lateral epicondylitis regarding pain.

  2. 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.
Condition or Disease Intervention/Treatment Phase
  • Combination Product: Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapy
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Masking Description:
Randomization using envelop
Primary Purpose:
Treatment
Official Title:
Combined Shockwave Therapy Versus Focused Shockwave Therapy in Patients With Lateral Epicondylitis
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

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).

Combination Product: Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapy
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).
Other Names:
  • Conventional therapy for tennis elbow

    		•
    Experimental: Group B

    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).

    Combination Product: Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapy
    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).
    Other Names:
  • Conventional therapy for tennis elbow

    		•
    Experimental: Group C

    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).

    Combination Product: Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapy
    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).
    Other Names:
  • Conventional therapy for tennis elbow

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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. [3 months]

      amount of pain the VAS scale will be employed, where 0 indicates "no pain" and 10 indicates "most severe pain

    2. rated-tennis-elbow-questionnaire for hand function assessment [3 months]

      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)

    3. Grip strength will be measured using the CAMRY digital hand dynamometer, model EH101 [3 months]

      Device used to test the hand grib strength

    Secondary Outcome Measures

    1. For patient selection Mill's Test [Before the study for patient selection]

      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.

    2. Maudsley's test [Before the study for patient selection]

      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.

    3. Cozen's Test [Before the study for patient selection]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mennallah Ahmed Mohamed Anwar Elgendy

    Investigators

    • Study Director: RANIA REDA, A. Prof Dr., cairo uni
    • Study Director: NEVEEN Abdelraoof, Prof. Dr., cairo uni
    • Principal Investigator: Menna allah Elgendy, Bachelor, cairo uni
    • Study Director: Titus Bertolini, Dr. med., Medicum clinics Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mennallah Ahmed Mohamed Anwar Elgendy, Principal investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05853029
    Other Study ID Numbers:
    • Shockwave on tennis elbow
    First Posted:
    May 10, 2023
    Last Update Posted:
    May 10, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mennallah Ahmed Mohamed Anwar Elgendy, Principal investigator, Cairo University
    Lateral Epicondylitis , shockwave therapy
    Additional relevant MeSH terms:
    Tennis Elbow

    Study Results

    No Results Posted as of May 10, 2023