Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology

Early Phase 1TerminatedNCT01798693

University of North Carolina, Chapel Hill5 enrolled

Overview

Rotator Injury: * Strength/range of Motion * ASES, VAS

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rotator Cuff/Shoulder Structure and Function

Interventions

Placebo (maltodextrin)DIETARY_SUPPLEMENT

Multi-nutrient BlendDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Between 18-65 years old * Diagnosed with rotator cuff injury that will not be treated surgically 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

Locations (1)

UNC Orthopedics and Exercise and Sport Medicine

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Change in shoulder function, pain, strength and range of motion

Time frame: Change from baseline to four, six, and twelve weeks

Data from ClinicalTrials.gov

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