Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology

May 11, 2015 updated by: Abbie Smith-Ryan, PhD, University of North Carolina, Chapel Hill

Rotator Injury:

  • Strength/range of Motion
  • ASES, VAS

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • UNC Orthopedics and Exercise and Sport Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo (maltodextrin)
Maltodextrin
Dietary supplement: Placebo (maltodextrin)
Active Comparator: Multi-Nutrient Blend
Blend of vitamins, minerals, and amino acids, given twice daily
Dietary supplement: Multi-nutrient Blend

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in shoulder function, pain, strength and range of motion
Time Frame: Change from baseline to four, six, and twelve weeks
Change from baseline to four, six, and twelve weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

January 18, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (Estimate)

February 26, 2013

Study Record Updates

Last Update Posted (Estimate)

May 13, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ORB-12-2374

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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