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NCT Number: NCT07620678

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

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.

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Key information

Conditions

Lateral Epicondylitis (Tennis Elbow) Arm Injuries Elbow Injuries Elbow Tendinopathy Lateral Epicondylitis Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ankara, Cankaya, Turkey (Türkiye)

About this study

Lateral epicondylitis is a common musculoskeletal disorder associated with pain, reduced grip strength, and impaired upper extremity function. This study aimed 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 their relative effectiveness 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. Conventional treatment consisted of home exercise and splinting. ESWT was applied in 3 sessions (2000 pulses, 0.15 mJ/mm²), while the DPT group received a single ultrasound-guided 5% dextrose injection.

Primary outcomes included Visual Analog Scale pain scores for rest, night pain, resisted wrist extension, and grip pain. Secondary outcomes included QuickDASH, PRTEE, grip strength measured with a Jamar dynamometer, and ultrasonographic assessment of common extensor tendon thickness. Clinical assessments were performed at baseline, 1, 3, and 6 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Conventional Treatment group

Behavioral

Splinting and home exercise program

Extracorporeal Shock Wave Therapy (ESWT)

Device

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

Dextrose prolotherapy (DPT)

Procedure

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

Primary outcomes

  1. VAS Resisted Wrist Extension Pain

    Time frame: Baseline, 1 month, 3 months, and 6 months after treatment

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

  2. VAS Gripping Pain

    Time frame: Baseline, 1 month, 3 months, and 6 months after treatment

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

  3. VAS Resting Pain

    Time frame: Baseline, 1 month, 3 months, and 6 months after treatment

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

  4. VAS Night Pain

    Time frame: Baseline, 1 month, 3 months, and 6 months after treatment

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

Secondary outcomes

  1. Quick-DASH Score

    Time frame: Baseline, 1 month, 3 months, and 6 months after treatment

    Functional disability assessed using the Quick Disabilities of the Arm, Shoulder and Hand questionnaire. The QuickDASH score ranges from 0 to 100, where 0 indicates no symptoms and normal upper extremity function, while 100 indicates the highest symptom severity and the poorest functional status.

  2. PRTEE Score

    Time frame: Baseline, 1 month, 3 months, and 6 months after treatment

    Functional outcome assessed using the Patient-Rated Tennis Elbow Evaluation questionnaire. The PRTEE consists of 15 items divided into two subscales: pain (5 items) and function (10 items). The total score ranges from 0 to 100, with 0 indicating no pain and normal function, and 100 indicating the highest pain severity and the poorest functional status. Higher scores reflect greater pain intensity and functional impairment.

  3. Grip Strength

    Time frame: Baseline and 6 months

    Grip strength measured using a Jamar dynamometer.

  4. Common Extensor Tendon Thickness

    Time frame: Baseline and 6 months

    Ultrasonographic measurement of common extensor tendon thickness.

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

Comparison of the Effectiveness of Extracorporeal Shock Wave Therapy and 5% Dextrose Prolotherapy in Patients With Lateral Epicondylitis: A Prospective Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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