Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology

Rotator Cuff/Shoulder Structure and Function Clinical Trial

Official title:

Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01798693
• Other study ID #: ORB-12-2374
• Status: Terminated
• Phase: Phase 0
• First received: January 18, 2013
• Last updated: May 11, 2015
• Start date: August 2013
• Est. completion date: August 2014

Study information

• Verified date: May 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: University of North Carolina: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Rotator Injury:

• Strength/range of Motion

• ASES, VAS

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff/Shoulder Structure and Function

Intervention

Dietary Supplement:
• Placebo (maltodextrin)

• Multi-nutrient Blend

Locations

Country	Name	City	State
United States	UNC Orthopedics and Exercise and Sport Medicine	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in shoulder function, pain, strength and range of motion		Change from baseline to four, six, and twelve weeks	No