Chronic Knee PainNCT05315934
Comparing the Effects of Upper and Lower Body Aerobic Exercise on Pain in Individuals With Chronic Knee Pain
A study testing Upper body aerobic exercise and Lower body aerobic exercise in people with Chronic Knee Pain, run by University of Bath at 1 site in United Kingdom.
Trial summary
The investigators want to compare the effects of upper versus lower body moderate aerobic exercise on the experience of pain in individuals with chronic knee pain. Participants will attend the laboratory on 4 separate occasions to complete a series of exercise tests and experimental pain tests. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Knee Pain
- What is being tested?
- Upper body aerobic exercise and Lower body aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Feb 2020to 2 Jan 2022
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥45 years
- Male or female
- Knee pain for ≥3 months
- Activity related joint pain
- No joint related morning stiffness, or morning stiffness lasting less than 30 minutes.
Who cannot join
- Specific joint injury within the last 6 months
- Inability to undertake cycling exercise
- Use of anti-inflammatory medication
- Smoker (or having quit <6 months ago)
- Osteoarthritis at any upper body sites that would affect ability to complete arm-cycling exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of the Effects of Upper Versus Lower Body Aerobic Exercise on the Experience of Pain in Individuals With Chronic Knee Pain
The investigators want to compare the effects of upper versus lower body moderate aerobic exercise on the experience of pain in individuals with chronic knee pain. Participants will attend the laboratory on 4 separate occasions to complete a series of exercise tests and experimental pain tests.
Read the detailed description
Pain has a multifaceted nature encompassing peripheral drivers (i.e. loading), peripheral and central nervous systems (peripheral and central sensitisation) and cognition (i.e. fear). Most recently, evidence supports that chronic pain in OA may cause alterations to the peripheral and central nervous systems. Despite this, current research has mainly targeted peripheral drivers (usually weight reduction) and cognition (educational programmes) with results highlighting that such methods are not always effective in reducing pain. It would be useful to provide a wider range of choice when prescribing exercise for OA for those which the current prescription is ineffective or un-desirable.
Acutely, both localised and generalised exercise involving the knee joint in individuals with KOA is known to increase symptomatic pain in some. However, research suggests that diverting exercise away from the affected joint may improve pain perception and pain experience in a subset of individuals by targeting cognition (attention away from the joint) and alleviating peripheral drivers of pain (reduced loading) while still presenting systemic physiological benefits that come with acute aerobic exercise which target peripheral and central sensitisation. Currently, there is only one study (Burrows et al, 2014) which has compared the effects of acute upper vs. lower body exercise on pain perception in KOA patients and this was employing resistance exercise. Although this study found positive effects of upper body exercise on pain, this pain was experimentally induced, and symptomatic pain was not measured.
The investigators aim is to determine the effects of a single bout of upper body aerobic exercise on experimentally induced and symptomatic pain in individuals with chronic knee pain in comparison with lower body aerobic exercise.
- Conditions
- Chronic Knee Pain
- Being tested
- Upper body aerobic exercise, Lower body aerobic exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper body aerobic exerciseOther
Participants will perform 30 minutes of continuous exercise on the arm-crank ergometer.
Lower body aerobic exerciseOther
Participants will perform 30 minutes of continuous exercise on the cycle ergometer.
| Study group | Role | What they receive |
|---|---|---|
| Upper Body Aerobic Exercise | Experimental | Participants will perform 30 minutes of arm-crank cycling at a moderate exercise intensity based off the participants perceived RPE13 Receives: Other: Upper body aerobic exercise |
| Lower Body Aerobic Exercise | Experimental | Participants will perform 30 minutes of static cycling at a moderate exercise intensity based off the participants perceived RPE13 Receives: Other: Lower body aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Symptomatic Pain
Change in symptomatic pain measured via Visual Analogue Scale (VAS) from pre- to post-exercise on a 0-10 scale where 0 is no pain at all and 10 is the worst pain imaginable
Measured: Immediately pre and immediately-post exercise
Secondary outcomes (2)
Acute Experimental Pain
Change in experimental pain via Pressure pain threshold and Mechanical detection threshold from pre- to post- exercise
Measured: Immediately pre and immediately-post exercise
Follow up Symptomatic Pain
Average symptomatic pain in the 7 days following each trial visit measured on a 0-10 Visual Analogue Scale (VAS) where 0 indicates no pain at all and 10 indicates worst pain imaginable
Measured: 1-7 days post exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start4 Feb 2020
- Primary completion2 Jan 2022
- Study completion2 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Knee 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Bilzon, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315934
- Sponsor's protocol ID
- EP 18/19 088
- Status last verified
- Jul 2022
- First submitted
- 17 May 2020
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymous individual data for all outcomes may be made available.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effects of Upper Versus Lower Body Aerobic Exercise on the Experience of Pain in Individuals With Chronic Knee Pain
- ClinicalTrials.gov ID
- NCT05315934
- Acronym / sponsor ID
- EP 18/19 088
- Conditions
- Chronic Knee Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 2 Jan 2022 (actual)
- Study completion
- 2 Jan 2022 (actual)
- First posted
- 7 Apr 2022 (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.
The investigators want to compare the effects of upper versus lower body moderate aerobic exercise on the experience of pain in individuals with chronic knee pain. Participants will attend the laboratory on 4 separate occasions to complete a series of exercise tests and experimental pain tests.
Detailed description
Pain has a multifaceted nature encompassing peripheral drivers (i.e. loading), peripheral and central nervous systems (peripheral and central sensitisation) and cognition (i.e. fear). Most recently, evidence supports that chronic pain in OA may cause alterations to the peripheral and central nervous systems. Despite this, current research has mainly targeted peripheral drivers (usually weight reduction) and cognition (educational programmes) with results highlighting that such methods are not always effective in reducing pain. It would be useful to provide a wider range of choice when prescribing exercise for OA for those which the current prescription is ineffective or un-desirable.
Acutely, both localised and generalised exercise involving the knee joint in individuals with KOA is known to increase symptomatic pain in some. However, research suggests that diverting exercise away from the affected joint may improve pain perception and pain experience in a subset of individuals by targeting cognition (attention away from the joint) and alleviating peripheral drivers of pain (reduced loading) while still presenting systemic physiological benefits that come with acute aerobic exercise which target peripheral and central sensitisation. Currently, there is only one study (Burrows et al, 2014) which has compared the effects of acute upper vs. lower body exercise on pain perception in KOA patients and this was employing resistance exercise. Although this study found positive effects of upper body exercise on pain, this pain was experimentally induced, and symptomatic pain was not measured.
The investigators aim is to determine the effects of a single bout of upper body aerobic exercise on experimentally induced and symptomatic pain in individuals with chronic knee pain in comparison with lower body aerobic exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper Body Aerobic Exercise | Experimental | Other: Upper body aerobic exerciseParticipants will perform 30 minutes of arm-crank cycling at a moderate exercise intensity based off the participants perceived RPE13 |
| Lower Body Aerobic Exercise | Experimental | Other: Lower body aerobic exerciseParticipants will perform 30 minutes of static cycling at a moderate exercise intensity based off the participants perceived RPE13 |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥45 years
- Male or female
- Knee pain for ≥3 months
- Activity related joint pain
- No joint related morning stiffness, or morning stiffness lasting less than 30 minutes.
Key exclusion criteria (5 listed)
- Specific joint injury within the last 6 months
- Inability to undertake cycling exercise
- Use of anti-inflammatory medication
- Smoker (or having quit <6 months ago)
- Osteoarthritis at any upper body sites that would affect ability to complete arm-cycling exercise.
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 |
|---|---|---|
| Upper body aerobic exerciseParticipants will perform 30 minutes of continuous exercise on the arm-crank ergometer. | Other | Upper Body Aerobic Exercise |
| Lower body aerobic exerciseParticipants will perform 30 minutes of continuous exercise on the cycle ergometer. | Other | Lower Body Aerobic Exercise |
Primary outcome
Acute Symptomatic Pain
Time frame: Immediately pre and immediately-post exercise
Change in symptomatic pain measured via Visual Analogue Scale (VAS) from pre- to post-exercise on a 0-10 scale where 0 is no pain at all and 10 is the worst pain imaginable
2 secondary outcomes
Acute Experimental Pain
Time frame: Immediately pre and immediately-post exercise
Follow up Symptomatic Pain
Time frame: 1-7 days post exercise
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 29 Jul 2022.
- Individual participant dataSharing planned: No. Anonymous individual data for all outcomes may be made available.
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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 Upper body aerobic exercise and Lower body aerobic exercise in people with Chronic Knee Pain, run by University of Bath 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 5 inclusion and 5 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 29 Jul 2022. 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. 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?
Acute Symptomatic Pain (time frame: Immediately pre and immediately-post exercise). 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 29 Jul 2022.