ESWT in Lateral Epicondylitis: Clinical,Ultrasonographic Evaluation

NCT06342518 | Completed DMC

• 1 other identifier: MU ESWT
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to check and compare how well shock wave therapy works for tennis elbow, both in terms of symptoms and what we can see on ultrasound.

Conditions

Lateral Epicondylitis; Tennis Elbow

Keywords

Extracorporeal Shock Wave Therapy (ESWT); sonographic assessment; Lateral epicondylitis

Outcome Measures

Primary Outcomes (6)

• Hand Grip Strength

  measured using the Jamar hand dynamometer

  Baseline, post-treatment(4th week), and one-month post-treatment (8th week)

• Pain severity

  Visual Analog Scale (VAS) which was scored from 0 (no pain) to 10 (extremely severe).

  Baseline, post-treatment(4th week), and one-month post-treatment (8th week)

• Functionality

  the Patient-Rated Tennis Elbow Evaluation (PRTEE) The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1. PAIN subscale (0 = no pain, 10 = worst imaginable) Pain - 5 items 2. FUNCTION subscale (0 = no difficulty, 10 = unable to do) Specific activities - 6 items Usual activities - 4 items In addition to the individual subscale scores, a total score can be computed on a scale of 100 (0 = no disability). Pain Score = Sum of the 5 pain items(out of 50) Best Score = 0, Worst Score =50 Function Score = Sum of the 10 function items, Divided by 2 (out of 50) Best Score = 0, Worst Score = 50 Computing the Total Score Total Score = Sum of pain + function scores Best Score = 0, Worst Score = 50 Best Score = 0, Worst Score = 100

  Baseline, post-treatment(4th week), and one-month post-treatment (8th week)

• Quality of life score

  Short Form-12 (SF-12), Patients are provided with the SF-12 questionnaire, which consists of 12 questions covering physical and mental health domains. The scoring yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). PCS mean score: 56,5 MSC mean score: 60.7 Scores above mean indicate a better-than-average health-related quality of life, while scores below mean suggest below-average health.

  Baseline, post-treatment(4th week), and one-month post-treatment (8th week)

• deep muscular tissue sensitivity

  pain pressure threshold (PPT) Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation. A varying pressure is applied from 0.5 to 1 kg/sec in a perpendicular direction relative to the muscle.

  Baseline, post-treatment(4th week), and one-month post-treatment (8th week)

• thickness of the common extensor tendon (CET)

  During ultrasonography for LE, the elbow is positioned in 90 degrees of flexion and the wrist in pronation. The ultrasound probe is placed longitudinally on the radial surface of the elbow. And common extensor tendon thickness was measured sonographically.

  Baseline, post-treatment(4th week), and one-month post-treatment (8th week)

Study Arms (2)

ESWT GROUP

EXPERIMENTAL

The ESWT group received radial ESWT on the painful lateral epicondyle once per week for a total of 3 sessions. A wrist resting splint, wrist extensor strengthening and stretching exercises, and ice treatment were administered to both groups.

Device: Extracorporeal Shock Wave Therapy (ESWT); Behavioral: Resting Splint , Exercises and ice

Sham-ESWT group

SHAM COMPARATOR

The Sham-ESWT group received Sham radial ESWT on the painful lateral epicondyle once per week for a total of 3 sessions. A wrist resting splint, wrist extensor strengthening and stretching exercises, and ice treatment were administered to both groups.

Device: Sham ESWT; Behavioral: Resting Splint , Exercises and ice

Interventions

Extracorporeal Shock Wave Therapy (ESWT) DEVICE

The ESWT group received radial ESWT each session with a total of 2000 pulses at a frequency of 10 Hz. A gel was used at the interface, and the air pressure was set at 1.8 bar per session.

ESWT GROUP

Sham ESWT DEVICE

The Sham-ESWT group received Sham radial ESWT each session, but without actual contact of the applicator. To enhance the illusion of treatment, gel was applied, and the device emitted sound at every shock

Sham-ESWT group

Resting Splint , Exercises and ice BEHAVIORAL

Ensuring proper usage of the wrist resting splint by the patient was confirmed during follow-up visits. The physician instructed the patients on stretching and strengthening exercises for wrist extensors, which they were asked to perform three times a day. Application of ice for 20 minutes every 3-4 hours during painful periods was recommended. During follow-up visits patients confirmed that they adherence to exercises and recommendations.

ESWT GROUP; Sham-ESWT group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• experiencing pain and tenderness in the lateral epicondyle while extending their wrist and fingers against resistance for at least 3 months

You may not qualify if:

• Patients who are pregnant or have a coagulation disorder, cervical radiculopathy, peripheral neuropathy, peripheral vasculopathy in the upper extremity, complex regional pain syndrome, local infections, systemic inflammatory disease, fibromyalgia syndrome, arthritis (including rheumatoid arthritis, spondylarthritis, and crystal-induced arthropathies), malignancy, or those who have been treated with corticosteroids, PRP, or autologous blood injection, as well as those who have received physical therapy agents, undergone upper-extremity surgical interventions, or have a history of direct trauma to the elbow or a history of fracture,

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department

Istanbul, 34732, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Extracorporeal Shockwave Therapy; Exercise; Ice

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Specialist of PMR,Principal Investigator

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 2, 2024
• Study Start: December 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)