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

M

Mahidol University

Status

Completed

Conditions

Chronic Rotator Cuff Tendinopathy

Treatments

Procedure: Prolotherapy
Device: Extracorporeal shock wave therapy (ESWT)

Study type

Interventional

Funder types

Other

Identifiers

NCT06700746
COA.No.MURA2023/839

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

24 participants in 2 patient groups

Prolotherapy
Experimental group
Description:
Solution 3.6 mL of 25% dextrose and 0.4 mL xylocaine total 4.0 mL And Solution 3.5 mL of 15% dextrose and 0.8 mL xylocaine total 4.3 mL each site Injection interval week 0, 3 and 6 Ultrasound guided injection Injection into enthesis points
Treatment:
Procedure: Prolotherapy
Extracorporeal shock wave therapy (ESWT)
Active Comparator group
Description:
ESWT Treatment interval week 0, 1 and 2 Energy intensity 0.20-0.25 mJ/mm2 per impulse Frequency 4-5 Hz for 2,000 shocks
Treatment:
Device: Extracorporeal shock wave therapy (ESWT)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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