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Completed

NCT Number: NCT06301152

Lateral Epicondylitis Treatment High Intensive Laser Therapy and Extracorporeal Shock Wave Therapy

Objectives: This study aims to evaluate and compare the short-term efficacy of high-intensity laser therapy (HILT) and extra corporeal shock wave therapy(ESWT) on pain, sensitivity, handgrip strength, and functions in the treatment of lateral epicondylitis (LE).

Material and methods: Forty five participants (age range, 18 to 65 years) with unilateral elbow pain were randomized into two groups. HILT group (n = 22) and the ESWT group (n = 23). The HILT and ESWT were administered three times a week for three weeks, and each treatment was combined with exercises. All patients in both groups were evaluated with ultrasonography for common extensor tendon(CET) thickness. A visual analog scale (VAS), Quick Disabilities of the Arm, Shoulder, and Hand (QDASH), and hand grip strength test were used to evaluate the patients before, one, and six weeks after treatment.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emine Esra Bilir

Ankara, Çankaya, 06800, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Clinical diagnosis of Lateral epicondylitis
  • Age >18

Exclusion criteria

  • Operation history about elbow
  • Received physical therapy, or had a steroid injection to the elbow in the three months
  • Cervical radiculopathy,
  • Elbow deformities,
  • Fibromyalgia syndrome,
  • Carpal tunnel syndrome,
  • Neurological impairments in the upper extremity,
  • Chronic inflammatory conditions,
  • Hemophilia,
  • Pregnant,
  • History of malignancy

Treatment and study plan

high intensive laser

Device

high-intensity laser ,three times in a week, for three weeks, 9 session

Extracorporeal Shock Wave Therapy

Device

extracorporeal shock wave therapy, once a week, for three weeks ,3 times,

Primary outcomes

  1. Visual analog scale

    Time frame: Baseline, 1 week and 6 weeks

    score 0-10, 0 minimum value, mean is no pain, score 10 is maximum value, pain is very severe

Secondary outcomes

  1. Quick Disability Arm, Shoulder and Hand questionary,

    Time frame: Baseline, 1 week and 6 weeks

    Quick Disability Arm, Shoulder and Hand questionary, minimum score 0 maximum score 100, high score value is associated with poor functional status

  2. hand grip strength

    Time frame: Baseline, 1 week and 6 weeks

    evaluates the maximum isometric contraction strength of hand and forearm muscles, 20-69 age male 47-40kg, female 30-24kg is normal value. ow value is associated with poor function

  3. musculoskeletal ultrasonography

    Time frame: Baseline, 1 week and 6 weeks

    common extensor tendon thickness;>0.40-0.41cm measurement result is associated with thickening of the tendon

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Comparison of High Intensive Laser Therapy and Extracorporeal Shock Wave Therapy in Treatment of Lateral Epicondylitis: A Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 8, 2024
Registry last updated
Mar 8, 2024

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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