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

November 20, 2024 updated by: Songsuda Roongsaiwatana, Mahidol University

Efficacy of Dextrose Prolotherapy Compare With Extracorporeal Shock Wave Therapy 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Physical Medicine and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment
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
Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Study Director: Songsuda Roongsaiwatana, M.D., Mahidol University, Ramathibodi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2023

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

November 20, 2024

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Estimated)

November 22, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COA.No.MURA2023/839

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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