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

NCT03743519 | Completed

• 1 other identifier: Cherry juice
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellofemoral Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  6-weeks

Secondary Outcomes (6)

• COOP-WONCA - psychological wellbeing

  6-weeks

• Plasma urate

  6-weeks

• Creatinine

  6-weeks

• human TNF-alpha

  6-weeks

• High sensitivity C-reactive protein

  6-weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Cherry juice

EXPERIMENTAL

Dietary Supplement: Cherry juice

Interventions

Cherry juice DIETARY_SUPPLEMENT

30 mL of tart cherry juice concentrate, which will be diluted with 200 mL of water.

Cherry juice

Placebo DIETARY_SUPPLEMENT

Identical in taste and colour to the Cherry juice, but with no anthocyanin content

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Central Lancashire: lead

Study Sites (1)

University of Central Lancashire

Preston, Lancs, PR1 2HE, United Kingdom

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: November 10, 2018
• First Posted: November 16, 2018
• Study Start: May 30, 2019
• Primary Completion: May 30, 2020
• Study Completion: June 1, 2020
• Last Updated: July 21, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)