Clinical trial NCT04805242: Effects of Dextrose Prolotherapy in Rotator Cuff Disease
Official title: Effects of Dextrose Prolotherapy in Rotator Cuff Disease: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Disease
Keywords: Rotator Cuff Disease
Dextrose Prolotherapy
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective, randomized, controlled, single-blind study is to determine the effects of dextrose prolotherapy on shoulder pain and functions in patients with chronic rotator cuff disease.

Detailed description: Rotator cuff disease is a major cause of shoulder pain and disability. Non-surgical treatments to reduce pain and improve function have included therapeutic exercises, NSAIDs, subacromial corticosteroid injections. However, some patients are resistant to these conservative treatments. In recent years, prolotherapy has increased in popularity for the treatment of musculosketal conditions. Regenerative injection methods can be applied in resistant chronic rotator cuff disease. In this prospective, randomized controlled, single blind, interventional study, a total of 60 patients with shoulder pain due to rotator cuff disease who meet eligibility criteria will be enrolled in the study. Eligible participants will be randomly assigned to one of the two groups using computer-generated random numbers. In the dextrose prolotherapy group, ultrasound-guided prolotherapy injections will be applied under aseptic conditions at 0, 3, and 6 weeks. In the salin injection group, salin injections will be applied under aseptic conditions at 0, 3, and 6 weeks. Home exercise program will be apply to both groups. Participants are going to evaluate before injection, and at the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, with the Shoulder Pain and Disability Index (SPADI) change in pain and disability score, with The University of California and Los Angeles Rating Score (UCLA) change in pain and functional score and the change in the Ultrasound Shoulder Pathology Rating Scale (USPRS).

Eligibility criteria: Inclusion Criteria:

* Shoulder pain for more than 3 months
* Being resistant to conservative treatment for at least 3 months
* Being in the age range of 30-65
* Presence of rotator cuff disease detected in current magnetic resonance imaging and confirmed by clinical examination.

Exclusion Criteria:

* Presence of rheumatic disease or other systemic inflammatory diseases
* Having a diagnosis of uncontrolled diabetes mellitus
* Evidence of infection (systemically or locally on the shoulder)
* The presence of a previous operation on the shoulder
* Bleeding tendency (acquired or hereditary) \[INR\> 2 in the patient using coumadin\]
* Injected shoulder within the previous 8 weeks
* The presence of local anesthesia and corn allergy
* Passive shoulder abduction \<100 ° or external rotation \<25 °
* Rotator cuff calcification diameter\> 0.8cm in current direct graph or Usg
* Presence of serious comorbidity

Primary outcomes:
measure: Change from baseline activity pain score at 1-months and 3-months
timeFrame: Baseline, 1-month, 3-month
Secondary outcomes:
measure: Change from baseline rest pain score at 1-months and 3-months
timeFrame: Baseline, 1-month, 3-month
measure: Change from baseline night pain score at 1-months and 3-months
timeFrame: Baseline, 1-month, 3-month
measure: Change from baseline pain, disability at 1-months and 3-months
timeFrame: Baseline, 1-month, 3-month
measure: Change from baseline shoulder pain and function at 1-months and 3-months
timeFrame: Baseline, 1-month, 3-month
measure: Change from baseline rotator cuff structure at 1-months and 3-months
timeFrame: Baseline, 1-month, 3-month
measure: Change from baseline shoulder flexion muscle strenght and flexion angle at 1-months and 3-months
timeFrame: Baseline, 1-month, 3-month
measure: Change from baseline patient satisfaction at 1-months and 3-months
timeFrame: Baseline, 1-month, 3-month
measure: Change from baseline shoulder range of motion at 1-months and 3-months
timeFrame: Baseline, 1-month, 3-month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
state: Fatih
Study officials:
affiliation: Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
name: Selim Sezikli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
name: Demirhan Diracoglu, Prof.
role: STUDY_DIRECTOR
References: