The Efficacy of a Tart Cherry Drink for the Treatment of Patellofemoral Pain in Recreational Athletes.
Primary Purpose
Patellofemoral Pain
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cherry juice
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Patellofemoral Pain
Eligibility 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.
Sites / Locations
- University of Central Lancashire
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Cherry juice
Arm Description
Outcomes
Primary Outcome Measures
Knee injury and Osteoarthritis Outcome Score (KOOS) - patellofemoral scale
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
COOP-WONCA - psychological wellbeing
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.
Plasma urate
Creatinine
human TNF-alpha
High sensitivity C-reactive protein
Pittsburgh Sleep Quality Index
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.
Full Information
NCT ID
NCT03743519
First Posted
November 10, 2018
Last Updated
July 20, 2020
Sponsor
University of Central Lancashire
1. Study Identification
Unique Protocol Identification Number
NCT03743519
Brief Title
The Efficacy of a Tart Cherry Drink for the Treatment of Patellofemoral Pain in Recreational Athletes.
Official Title
The Efficacy of a Tart Cherry Drink for Patellofemoral Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 30, 2019 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Central Lancashire
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Cherry juice
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Cherry juice
Intervention Description
30 mL of tart cherry juice concentrate, which will be diluted with 200 mL of water.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Identical in taste and colour to the Cherry juice, but with no anthocyanin content
Primary Outcome Measure Information:
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) - patellofemoral scale
Description
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.
Time Frame
6-weeks
Secondary Outcome Measure Information:
Title
COOP-WONCA - psychological wellbeing
Description
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.
Time Frame
6-weeks
Title
Plasma urate
Time Frame
6-weeks
Title
Creatinine
Time Frame
6-weeks
Title
human TNF-alpha
Time Frame
6-weeks
Title
High sensitivity C-reactive protein
Time Frame
6-weeks
Title
Pittsburgh Sleep Quality Index
Description
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.
Time Frame
6-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Central Lancashire
City
Preston
State/Province
Lancs
ZIP/Postal Code
PR1 2HE
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of a Tart Cherry Drink for the Treatment of Patellofemoral Pain in Recreational Athletes.
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