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Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology

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ClinicalTrials.gov Identifier: NCT01798693
Recruitment Status : Terminated (Poor subject compliance and inadequate recruitment)
First Posted : February 26, 2013
Last Update Posted : May 13, 2015
Sponsor:
Information provided by (Responsible Party):
Abbie Smith-Ryan, PhD, University of North Carolina, Chapel Hill

Study Description
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Brief Summary:

Rotator Injury:

  • Strength/range of Motion
  • ASES, VAS

Condition or disease Intervention/treatment Phase
Rotator Cuff/Shoulder Structure and Function Dietary Supplement: Placebo (maltodextrin) Dietary Supplement: Multi-nutrient Blend Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology
Study Start Date : August 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in shoulder function, pain, strength and range of motion [ Time Frame: Change from baseline to four, six, and twelve weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798693


Locations
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United States, North Carolina
UNC Orthopedics and Exercise and Sport Medicine
Chapel Hill, North Carolina, United States
Sponsors and Collaborators
University of North Carolina, Chapel Hill
More Information
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Responsible Party: Abbie Smith-Ryan, PhD, Assistant Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01798693    
Other Study ID Numbers: ORB-12-2374
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015
Keywords provided by Abbie Smith-Ryan, PhD, University of North Carolina, Chapel Hill:
Shoulder
Supplement
Amino Acids
Collagen
Standard of Care
Additional relevant MeSH terms:
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Nutrients
Growth Substances
Physiological Effects of Drugs