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

NCT05853029 | Unknown

• 1 other identifier: Shockwave on tennis elbow
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.To determine the best effective modality between combined (focused and radial) and focused shockwave therapy for treatment of lateral epicondylitis regarding pain.
2. 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. 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.

Conditions

Epicondylitis

Keywords

Shockwave therapy; Lateral epicondylitis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Grip strength will be measured using the CAMRY digital hand dynamometer, model EH101

  Device used to test the hand grib strength

  3 months

Secondary Outcomes (3)

• For patient selection Mill's Test

  Before the study for patient selection

• Maudsley's test

  Before the study for patient selection

• Cozen's Test

  Before the study for patient selection

Study Arms (3)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Group C

EXPERIMENTAL

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

Interventions

Combined shockwave therapy & conventional therapy , focused shockwave therapy& conventional therapy , conventional therapy COMBINATION_PRODUCT

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).

Also known as: Conventional therapy for tennis elbow

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mennallah Ahmed Mohamed Anwar Elgendy: lead

Related Publications (26)

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MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• RANIA REDA, A. Prof Dr.

  cairo uni

  STUDY DIRECTOR

• NEVEEN Abdelraoof, Prof. Dr.

  cairo uni

  STUDY DIRECTOR

• Menna allah Elgendy, Bachelor

  cairo uni

  PRINCIPAL INVESTIGATOR

• Titus Bertolini, Dr. med.

  Medicum clinics Germany

  STUDY DIRECTOR

Central Study Contacts

Menna allah Elgendy, Bachelor

CONTACT

01010334319; Mennaallahelgendy@gmail.com

NEVEEN Abdelraoof, Prof. Dr

CONTACT

+20 106 4615553

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomization using envelop
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: May 10, 2023
• Study Start: August 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: August 16, 2023

Record last verified: 2023-08