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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-10

Study Completion Date

2024-11-20

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Rotator Cuff Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Prolotherapy

Intervention Type 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)

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

Group Type ACTIVE_COMPARATOR

Extracorporeal shock wave therapy (ESWT)

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No