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

Epicondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05853029
• Other study ID #: Shockwave on tennis elbow
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: February 2024

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: Menna allah Elgendy, Bachelor
• Phone: 01010334319
• Email: Mennaallahelgendy[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epicondylitis
• Tennis Elbow

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mennallah Ahmed Mohamed Anwar Elgendy

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Primary	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)	3 months
Primary	Grip strength will be measured using the CAMRY digital hand dynamometer, model EH101	Device used to test the hand grib strength	3 months
Secondary	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.	Before the study for patient selection
Secondary	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.	Before the study for patient selection
Secondary	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.	Before the study for patient selection