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OpenTrials
Completed

NCT Number: NCT06700746

Efficacy of Dextrose Prolotherapy Compare With ESWT in the Treatment of Chronic Rotator Cuff Tendinopathy

To compare the efficacy of dextrose solution injection with ESWT for pain reduction in rotator cuff tendinopathy.

Additionally, secondary objective is to evaluate DASH and active range of motion of shoulder joint

Completed

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Key information

Conditions

Chronic Rotator Cuff Tendinopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical medicine and rehabilitation

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic shoulder pain for at least 3 months
  • Unilateral affected side
  • History of unsuccessful conservative treatment
  • Age 18 years or older

Exclusion criteria

  • Rotator cuff complete tear
  • Local or generalized arthritis
  • Previous shoulder surgery
  • Previous history allergy to local anesthesia
  • Pregnancy
  • Current infectious or tumorous disease
  • Dysfunction in the neck or thoracic region of both
  • Coagulation disturbance

Treatment and study plan

Prolotherapy

Procedure

Prolotherapy is an injection of a relatively small volume of an irritant or sclerosing solution at sites of painful ligament and/or tendon insertions, and in adjacent joint space over the course of several treatment sessions

Extracorporeal Shock Wave Therapy (ESWT)

Device

Extracorporeal shock wave therapy (ESWT), a kind of physical modalities, generating acoustic pulses, that are high positive pressure amplitudes, subsequently transferring concentrated energy to small focal distant areas of 2-8 mm in diameter

Primary outcomes

  1. VAS score

    Time frame: Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment

    Pain reduction VAS

Secondary outcomes

  1. Function DASH score

    Time frame: Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment

    Disabilities of the arm, shoulder and hand

  2. Shoulder ROM

    Time frame: Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment

    Active range of motion:

    Forward flexion Abduction Internal rotation External rotation

    Active range of motion:

    Forward flexion Abduction Internal rotation External rotation

    Active range of motion:

    Forward flexion Abduction Internal rotation External rotation

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Efficacy of Dextrose Prolotherapy Compare With Extracorporeal Shock Wave Therapy in the Treatment of Chronic Rotator Cuff Tendinopathy

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 22, 2024
Registry last updated
Nov 22, 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.