Patellofemoral PainNCT03743519
The Efficacy of a Tart Cherry Drink for the Treatment of Patellofemoral Pain in Recreational Athletes.
A study testing Cherry juice in people with Patellofemoral Pain, run by University of Central Lancashire at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patellofemoral Pain
- What is being tested?
- Cherry juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 May 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recreationally active
- Suffering from mild to moderate patellofemoral pain with no evidence of any other condition.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Central Lancashire
Preston, Lancs, PR1 2HE
About this study
Official title: The Efficacy of a Tart Cherry Drink for Patellofemoral Pain.
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
- Being tested
- Cherry juice, Placebo
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cherry juiceDietary supplement
30 mL of tart cherry juice concentrate, which will be diluted with 200 mL of water.
PlaceboDietary supplement
Identical in taste and colour to the Cherry juice, but with no anthocyanin content
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Cherry juice | Experimental | Not described Receives: Dietary Supplement: Cherry juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-weeks
Secondary outcomes (6)
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.
Measured: 6-weeks
Plasma urate
Measured: 6-weeks
Creatinine
Measured: 6-weeks
human TNF-alpha
Measured: 6-weeks
High sensitivity C-reactive protein
Measured: 6-weeks
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.
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start30 May 2019
- Primary completion30 May 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Sinclair, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743519
- Sponsor's protocol ID
- Cherry juice
- Status last verified
- May 2019
- First submitted
- 10 Nov 2018
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Tart Cherry Drink for Patellofemoral Pain.
- ClinicalTrials.gov ID
- NCT03743519
- Acronym / sponsor ID
- Cherry juice
- Conditions
- Patellofemoral Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Cherry juice | Experimental | Dietary Supplement: Cherry juice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Recreationally active
- Suffering from mild to moderate patellofemoral pain with no evidence of any other condition.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cherry juice30 mL of tart cherry juice concentrate, which will be diluted with 200 mL of water. | Dietary supplement | Cherry juice |
| PlaceboIdentical in taste and colour to the Cherry juice, but with no anthocyanin content | Dietary supplement | Placebo |
Primary outcome
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.
6 secondary outcomes
COOP-WONCA - psychological wellbeing
Time frame: 6-weeks
Plasma urate
Time frame: 6-weeks
Creatinine
Time frame: 6-weeks
human TNF-alpha
Time frame: 6-weeks
High sensitivity C-reactive protein
Time frame: 6-weeks
Pittsburgh Sleep Quality Index
Time frame: 6-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Patellofemoral Pain
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Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
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Stabilization vs Corrective Exercise in PFP
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Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cherry juice in people with Patellofemoral Pain, run by University of Central Lancashire at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and Osteoarthritis Outcome Score (KOOS) - patellofemoral scale (time frame: 6-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.