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Completed

NCT Number: NCT03743519

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

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.

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Key information

Conditions

Patellofemoral Pain Joint Diseases Musculoskeletal Diseases Patellofemoral Pain Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Lancashire

Preston, Lancs, PR1 2HE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cherry juice

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Central Lancashire

Other

Registry information

Official study title

The Efficacy of a Tart Cherry Drink for Patellofemoral Pain.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 16, 2018
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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