Clinical trial

Effects of Hypertonic Dextrose Prolotherapy on Conventional Physical Therapy in Patients With Subdeltoid Bursitis: a Double-blind, Randomized, Placebo-controlled Study

Name

2023SKHADR033

Description

Physical therapy and hypertonic dextrose prolotherapy are often used to treat subdeltoid bursitis. This study aims to investigate the effects of hypertonic dextrose injection on physical therapy through a double-blind, randomized study.

Trial arms

Trial start

2023-06-20

Estimated PCD

2024-06-30

Trial end

2024-06-30

Status

Not yet recruiting

Phase

Early phase I

Treatment

Dextrose

Dextrose injection plus physical therapy

Arms:

Intervention group

Other names:

physical therapy

Normal saline

Normal saline injection plus physical therapy

Arms:

Control group

Other names:

physical therapy

Size

Primary endpoint

Shoulder pain and disability index

score change from baseline to 1 week, 1 month and 3 months after treatment

Eligibility criteria

Inclusion Criteria: * clinical diagnosis of subdeltoid bursitis age 20 or older 20 at least one positive in the painful arc, neer test, or Hawkins test can attend 3 months of intervention and follow up Exclusion Criteria: * history of malignancy previous shoulder operation or injury previous shoulder injections in the past 3 months

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 46, 'type': 'ESTIMATED'}}

Updated at

2023-06-27

1 organization

1 product

1 drug

3 indications

Organization

Taipei Medical University

Product

Indication

Indication

Indication

Drug