Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology

Early Phase 1

Terminated

• Conditions: Rotator Cuff/Shoulder Structure and Function
• Interventions: Dietary Supplement: Multi-nutrient Blend; Dietary Supplement: Placebo (maltodextrin)

• Registration Number: NCT01798693
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

Rotator Injury:

* Strength/range of Motion

* ASES, VAS

Detailed Description

The addition of a nutritional therapy to a standardized physical therapy program, may expedite recovery from shoulder injury. An attractive feature of this approach is the development of an efficacious adjunct therapy that is economically superior to traditional therapy modalities and logistically feasible.

Study Timeline

• Study First Submitted: 2013-01-18
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-26
• Study Start: 2013-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Between 18-65 years old
• Diagnosed with rotator cuff injury that will not be treated surgically

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Exclusion Criteria

• Have received a previous injection therapy (platelet-rich plasma or corticosteroid injection) within previous 6 months
• Have used the following supplements in the previous 2 weeks: Vitamin C or D, or protein supplements
• Have poorly controlled type I or type II diabetes (HgB A1C > 9.5%) or renal insufficiency (GFR < 60 ml/min).
• Have an inability to participate in rehabilitation exercises.
• Are diagnosed with arthritis, rheumatoid arthritis, or any other autoimmune or rheumatologic disease
• Have musculoskeletal pathology in a neighboring joint or structure
• Have an allergy to any component of the nutritional supplement
• Are consuming warfarin

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-Nutrient Blend	Multi-nutrient Blend	Blend of vitamins, minerals, and amino acids, given twice daily
Placebo (maltodextrin)	Placebo (maltodextrin)	Maltodextrin

Primary Outcome Measures

Name	Time	Method
Change in shoulder function, pain, strength and range of motion	Change from baseline to four, six, and twelve weeks

Trial Locations

Locations (1)

UNC Orthopedics and Exercise and Sport Medicine; 🇺🇸 Chapel Hill, North Carolina, United States