NCT06700746

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

10 months

First QC Date

November 20, 2024

Last Update Submit

November 20, 2024

Conditions

Chronic Rotator Cuff Tendinopathy

Outcome Measures

Primary Outcomes (1)

  • VAS score

    Pain reduction VAS

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

Secondary Outcomes (2)

  • Function DASH score

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

  • Shoulder ROM

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

Study Arms (2)

Prolotherapy

EXPERIMENTAL

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

Extracorporeal shock wave therapy (ESWT)

ACTIVE COMPARATOR

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

ProlotherapyPROCEDURE

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

Prolotherapy
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

Extracorporeal shock wave therapy (ESWT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical medicine and rehabilitation

Bangkok, 10400, Thailand

Location

Related Publications (2)

  • 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.

    PMID: 27429562BACKGROUND

  • 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.

    PMID: 22672772BACKGROUND

MeSH Terms

Interventions

ProlotherapyExtracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsUltrasonic TherapyDiathermyHyperthermia, InducedPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Songsuda Roongsaiwatana, M.D.

    Ramathibodi Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2024

First Posted

November 22, 2024

Study Start

November 10, 2023

Primary Completion

September 1, 2024

Study Completion

November 20, 2024

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)