Comparison of ESWT and Single-Session 5% Dextrose Prolotherapy in Lateral Epicondylitis

NCT07620678 | Completed

• 1 other identifier: E1-23-4037
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Lateral epicondylitis is a common musculoskeletal disorder associated with pain and impaired upper extremity function. The aim of this study was to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and single-session 5% dextrose prolotherapy (DPT) in patients with lateral epicondylitis and to evaluate the relative superiority of these treatment approaches during short- and mid-to-long-term follow-up. Ninety-six patients were allocated into three groups: conventional treatment alone, conventional treatment plus ESWT, and conventional treatment plus DPT. Pain, functional status, grip strength, and common extensor tendon thickness were evaluated during follow-up.

Conditions

Lateral Epicondylitis (Tennis Elbow); Lateral Epicondylitis

Keywords

Lateral Epicondylitis; Tennis Elbow; Dextrose Prolotherapy; ESWT; Extracorporeal Shock Wave

Outcome Measures

Primary Outcomes (4)

• VAS Resisted Wrist Extension Pain

  Pain during resisted wrist extension assessed using the Visual Analog Scale (VAS).

  Baseline, 1 month, 3 months, and 6 months after treatment

• VAS Gripping Pain

  Pain intensity during gripping assessed using the Visual Analog Scale (VAS).

  Baseline, 1 month, 3 months, and 6 months after treatment

• VAS Resting Pain

  Resting pain assessed using the Visual Analog Scale (VAS).

  Baseline, 1 month, 3 months, and 6 months after treatment

• VAS Night Pain

  Night pain assessed using the Visual Analog Scale (VAS).

  Baseline, 1 month, 3 months, and 6 months after treatment

Secondary Outcomes (4)

• Quick-DASH Score

  Baseline, 1 month, 3 months, and 6 months after treatment

• PRTEE Score

  Baseline, 1 month, 3 months, and 6 months after treatment

• Grip Strength

  Baseline and 6 months

• Common Extensor Tendon Thickness

  Baseline and 6 months

Study Arms (3)

Conventional Treatment + ESWT

ACTIVE COMPARATOR

Three treatment sessions administered at weekly intervals using 2000 pulses per session at an energy flux density of 0.15 mJ/mm².

Behavioral: Conventional Treatment group; Device: Extracorporeal Shock Wave Therapy (ESWT)

Conventional Treatment + Dextrose Prolotherapy

ACTIVE COMPARATOR

Single-session ultrasound-guided injection of 1 mL 5% dextrose.

Behavioral: Conventional Treatment group; Procedure: Dextrose prolotherapy (DPT)

Conventional Treatment

ACTIVE COMPARATOR

Splinting and home exercise program.

Behavioral: Conventional Treatment group

Interventions

Conventional Treatment group BEHAVIORAL

Splinting and home exercise program

Conventional Treatment; Conventional Treatment + Dextrose Prolotherapy; Conventional Treatment + ESWT

Extracorporeal Shock Wave Therapy (ESWT) DEVICE

3 sessions, weekly, 4Hz, 2000 pulses/session, 0.15 mJ/mm².

Conventional Treatment + ESWT

Dextrose prolotherapy (DPT) PROCEDURE

Single-session ultrasound-guided 1 mL 5% dextrose injection.

Conventional Treatment + Dextrose Prolotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-75 years
• Clinical and ultrasonographic diagnosis of lateral epicondylitis
• Symptoms persisting for at least 3 months
• Visual Analog Scale (VAS) score ≥4
• Resistance to previous medical treatment
• Ability to comply with study procedures and complete questionnaires

You may not qualify if:

• Injection treatment for lateral epicondylitis within the previous 3 months
• History of trauma within the previous 3 months
• Cervical disc herniation
• Median or ulnar tunnel neuropathy
• Medial epicondylitis
• Anticoagulant therapy use
• Pregnancy or breastfeeding
• Psychiatric disorders or cognitive impairment interfering with questionnaire -completion
• Allergy to the treatment solution
• History of upper extremity surgery or fracture
• Rheumatoid arthritis
• Connective tissue diseases such as dermatomyositis

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

SBU Ankara Physical Medicine and Rehabilitation Training and Research Hospital Ankara, Turkey

Ankara, Cankaya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Extracorporeal Shockwave Therapy

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Medicine and Rehabilitation

Model Details: Participants were allocated into three parallel groups: conventional treatment alone, conventional treatment plus extracorporeal shock wave therapy (ESWT), and conventional treatment plus single-session 5% dextrose prolotherapy.

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: October 1, 2023
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)