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The Efficacy of a Tart Cherry Drink for the Treatment of Patellofemoral Pain in Recreational Athletes.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743519
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan Sinclair, University of Central Lancashire

Brief Summary:

Patellofemoral pain (PFP) is the most common chronic pathology in sports medicine and physiotherapy clinics. As pain and inflammation are the main symptoms of PFP, non-steroidal anti-inflammatory and analgesic medications are often utilized to decrease pain and inflammation; however alternative treatments are increasingly being sought due to the cardiovascular and gastrointestinal side effects of traditional pain medications. Most researchers advocate conservative treatment, though there is still insufficient clarity regarding the effectiveness of conservative treatment modalities. Dietary interventions for PFP have not received any attention in clinical literature, yet there is a growing body of evidence indicating that cherries have significant anti-inflammatory, antioxidant and pain-mediating effects.

Therefore, the primary purpose of the proposed investigation was to test (using a randomized control investigation) the ability of a tart cherry juice blend to provide symptom relief in recreational athletes with PFP and to understand the biological and mechanical mechanisms behind any changes in PFP symptoms.


Condition or disease Intervention/treatment Phase
Patellofemoral Pain Dietary Supplement: Cherry juice Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of a Tart Cherry Drink for Patellofemoral Pain.
Actual Study Start Date : May 30, 2019
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : June 1, 2020

Arm Intervention/treatment
Placebo Comparator: Placebo Dietary Supplement: Placebo
Identical in taste and colour to the Cherry juice, but with no anthocyanin content

Experimental: Cherry juice Dietary Supplement: Cherry juice
30 mL of tart cherry juice concentrate, which will be diluted with 200 mL of water.




Primary Outcome Measures :
  1. Knee injury and Osteoarthritis Outcome Score (KOOS) - patellofemoral scale [ Time Frame: 6-weeks ]
    This is a questionnaire based measurement that allows participants to subjectively rate the extent of their patellofemoral pain symptoms. This measurement is scored on a 0-100 scale with 100 indicating no pain.


Secondary Outcome Measures :
  1. COOP-WONCA - psychological wellbeing [ Time Frame: 6-weeks ]
    This is a questionnaire based measurement that allows participants to subjectively rate their psychological wellbeing. This measurement provides a value that is an average score of 6 questions (overall health, daily activities, physical fitness, feelings, social activities and change in health) that range from 1-5. A lower score indicates better psychological wellbeing.

  2. Plasma urate [ Time Frame: 6-weeks ]
  3. Creatinine [ Time Frame: 6-weeks ]
  4. human TNF-alpha [ Time Frame: 6-weeks ]
  5. High sensitivity C-reactive protein [ Time Frame: 6-weeks ]
  6. Pittsburgh Sleep Quality Index [ Time Frame: 6-weeks ]
    The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recreationally active
  • Suffering from mild to moderate patellofemoral pain with no evidence of any other condition.

Exclusion Criteria:

  • Rheumatoid arthritis or other systemic inflammatory condition
  • Chronic pain syndrome
  • Corticosteroid medication in last 2 months (intra-articular or oral)
  • Intra-articular injections of hyaluronic acid in the last 9 months
  • Pregnancy
  • Diabetes
  • Food allergies to cherries.

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): NCT03743519


Contacts
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Contact: Jonathan Sinclair, PhD 07875651533 jksinclair@uclan.ac.uk

Locations
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United Kingdom
University of Central Lancashire Recruiting
Preston, Lancs, United Kingdom, PR1 2HE
University of Central Lancashire Recruiting
Preston, Lancs, United Kingdom, PR1 2HE
Contact: Jonathan Sinclair, PhD       jksinclair@uclan.ac.uk   
Sponsors and Collaborators
University of Central Lancashire
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Responsible Party: Jonathan Sinclair, Senior Lecturer, University of Central Lancashire
ClinicalTrials.gov Identifier: NCT03743519    
Other Study ID Numbers: Cherry juice
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No