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CompletedNCT06700746Updated Nov 22, 2024

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

An interventional study of Prolotherapy and Extracorporeal shock wave therapy (ESWT) in Chronic Rotator Cuff Tendinopathy, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by Mahidol University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Nov 2023, registered Nov 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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

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Conditions studied

  • Chronic Rotator Cuff Tendinopathy

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03

In context

Tendinopathy

413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.

This study's enrollment of 24 is below the median of 50 across 339 interventional studies indexed under Tendinopathy.

Browse Tendinopathy studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Prolotherapy

    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

    Procedure: Prolotherapy

  • Active comparator
    Extracorporeal shock wave therapy (ESWT)

    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

    Device: Extracorporeal shock wave therapy (ESWT)

Interventions

  • ProcedureProlotherapy

    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

  • DeviceExtracorporeal shock wave therapy (ESWT)

    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

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What researchers measure

Primary outcomes

  1. VAS score

    Pain reduction VAS

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

Secondary outcomes

  1. Function DASH score

    Disabilities of the arm, shoulder and hand

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

  2. Shoulder ROM

    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

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

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Study locations

1 site
  • Physical medicine and rehabilitation
    Bangkok, 10400, Thailand
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References and documents

Publications

  • Hauser RA, Lackner JB, Steilen-Matias D, Harris DK. A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain. Clin Med Insights Arthritis Musculoskelet Disord. 2016 Jul 7;9:139-59. doi: 10.4137/CMAMD.S39160. eCollection 2016. PubMed 27429562 ↗
  • Galasso O, Amelio E, Riccelli DA, Gasparini G. Short-term outcomes of extracorporeal shock wave therapy for the treatment of chronic non-calcific tendinopathy of the supraspinatus: a double-blind, randomized, placebo-controlled trial. BMC Musculoskelet Disord. 2012 Jun 6;13:86. doi: 10.1186/1471-2474-13-86. PubMed 22672772 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06700746
Lead sponsor
Mahidol University
Responsible party
Songsuda Roongsaiwatana (Principal Investigator, Mahidol University) — Principal investigator
First posted
Nov 22, 2024
Start date
Nov 10, 2023
Primary completion
Sep 1, 2024
Completion
Nov 20, 2024
Last update
Nov 22, 2024

Study contacts

Songsuda Roongsaiwatana, M.D.
study director · Mahidol University, Ramathibodi Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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