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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07620678
Enrollment
96
Registered
2026-06-02
Start date
2023-10-01
Completion date
2025-08-29
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lateral Epicondylitis, Lateral Epicondylitis (Tennis Elbow)

Keywords

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

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.

Detailed description

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.

Interventions

Splinting and home exercise program

DEVICEExtracorporeal Shock Wave Therapy (ESWT)

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

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

Sponsors

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
VAS Resisted Wrist Extension PainBaseline, 1 month, 3 months, and 6 months after treatmentPain during resisted wrist extension assessed using the Visual Analog Scale (VAS).
VAS Gripping PainBaseline, 1 month, 3 months, and 6 months after treatmentPain intensity during gripping assessed using the Visual Analog Scale (VAS).
VAS Resting PainBaseline, 1 month, 3 months, and 6 months after treatmentResting pain assessed using the Visual Analog Scale (VAS).
VAS Night PainBaseline, 1 month, 3 months, and 6 months after treatmentNight pain assessed using the Visual Analog Scale (VAS).

Secondary

MeasureTime frameDescription
Quick-DASH ScoreBaseline, 1 month, 3 months, and 6 months after treatmentFunctional 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.
PRTEE ScoreBaseline, 1 month, 3 months, and 6 months after treatmentFunctional 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.
Grip StrengthBaseline and 6 monthsGrip strength measured using a Jamar dynamometer.
Common Extensor Tendon ThicknessBaseline and 6 monthsUltrasonographic measurement of common extensor tendon thickness.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026