FibromyalgiaNCT03778476
Isometric Exercise and Endogenous Pain Inhibition
A study testing Isometric Exercise in people with Fibromyalgia, run by Marquette University at 1 site in United States.
Trial summary
The purpose of this study is to identify the acute effects of isometric exercise on the inhibition of pain in individuals with fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Isometric Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2018to 29 Oct 2019
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18-75 diagnosed with fibromyalgia or healthy controls will be included in the study.
Who cannot join
- cardiovascular disease, cancer, pregnancy, arthritis, diabetes, claustrophobia, Reynaud's disease, osteoporosis, neuropathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Isometric Exercise and Endogenous Pain Modulation
The purpose of this study is to identify the acute effects of isometric exercise on the inhibition of pain in individuals with fibromyalgia.
Read the detailed description
Fibromyalgia syndrome (FMS) is a chronic pain condition that is characterized by widespread pain which affects 5-8% of the general population. Past research has shown that people with FMS demonstrate enhanced pain facilitation and reduced pain inhibition in the central nervous system. Incorporating a biopsychosocial model of pain may help develop strategies to prevent the functional decline and alleviate the suffering that occurs in this population. Exercise is a mainstay of pain rehabilitation with multiple health benefits, one of which is decreasing pain; a phenomenon known as exercise induced hypoalgesia (EIH). Emerging evidence has shown that exercise decreases pain facilitation in healthy adults and in some individuals with FMS. However, it's unclear whether exercise improves pain inhibition in individuals with FMS. The purpose of this study is to investigate endogenous pain inhibition, measured by conditioned pain modulation (CPM), following isometric exercise of the quadriceps muscle in individuals with FMS. In addition, factors that might affect this response such as physical activity, body composition, and psychosocial issues will be examined. Understanding how exercise impacts pain and the contributing factors will help guide the prescription of exercise to optimize pain rehabilitation.
- Conditions
- Fibromyalgia
- Being tested
- Isometric Exercise
- Keywords
- Exercise, pain sensitivity, fibromyalgia
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric ExerciseOther
Participants will be asked to hold a submaximal voluntary contraction of the quadriceps muscle as long as they can (task failure).
| Study group | Role | What they receive |
|---|---|---|
| Isometric Exercise | Experimental | Participants will perform a submaximal voluntary contraction of the quadriceps muscle to task failure. Receives: Other: Isometric Exercise |
| Quiet Rest | No intervention | Participants will sit quietly for a period of time that mimics the exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conditioned Pain Modulation
the change in pressure pain threshold (kPa) during or after the immersion of the foot in a cold water bath (approximately 6 degrees) compared with baseline (before foot submersion) constitutes the measure of conditioned pain modulation in this study.
Measured: baseline, immediately after exercise or quiet rest
Secondary outcomes (1)
Vibration Perception Threshold
a biothesiometer will be used to measure sense of vibration (threshold) local and distal from the exercising muscle.
Measured: baseline, immediately after exercise or quiet rest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start25 May 2018
- Primary completion29 Sep 2019
- Study completion29 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Model description
- The two groups will participate in two sessions receiving intervention or no intervention in a randomized manner.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Hoeger Bement, PT, PhD, Principal investigator, Marquette UniversityAli Alsouhibani, PT, MS, Study director, Marquette University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778476
- Sponsor's protocol ID
- HR3035
- Status last verified
- Feb 2021
- First submitted
- 12 Dec 2018
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isometric Exercise and Endogenous Pain Modulation
- ClinicalTrials.gov ID
- NCT03778476
- Acronym / sponsor ID
- HR3035
- Conditions
- Fibromyalgia
- Keywords
- Exercise, pain sensitivity, fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Study start
- 25 May 2018 (actual)
- Primary completion
- 29 Sep 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 19 Dec 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.
The purpose of this study is to identify the acute effects of isometric exercise on the inhibition of pain in individuals with fibromyalgia.
Detailed description
Fibromyalgia syndrome (FMS) is a chronic pain condition that is characterized by widespread pain which affects 5-8% of the general population. Past research has shown that people with FMS demonstrate enhanced pain facilitation and reduced pain inhibition in the central nervous system. Incorporating a biopsychosocial model of pain may help develop strategies to prevent the functional decline and alleviate the suffering that occurs in this population. Exercise is a mainstay of pain rehabilitation with multiple health benefits, one of which is decreasing pain; a phenomenon known as exercise induced hypoalgesia (EIH). Emerging evidence has shown that exercise decreases pain facilitation in healthy adults and in some individuals with FMS. However, it's unclear whether exercise improves pain inhibition in individuals with FMS. The purpose of this study is to investigate endogenous pain inhibition, measured by conditioned pain modulation (CPM), following isometric exercise of the quadriceps muscle in individuals with FMS. In addition, factors that might affect this response such as physical activity, body composition, and psychosocial issues will be examined. Understanding how exercise impacts pain and the contributing factors will help guide the prescription of exercise to optimize pain rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The two groups will participate in two sessions receiving intervention or no intervention in a randomized manner.
| Arm | Type | Receives |
|---|---|---|
| Isometric Exercise | Experimental | Other: Isometric ExerciseParticipants will perform a submaximal voluntary contraction of the quadriceps muscle to task failure. |
| Quiet Rest | No intervention | –Participants will sit quietly for a period of time that mimics the exercise. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women aged 18-75 diagnosed with fibromyalgia or healthy controls will be included in the study.
Key exclusion criteria (1 listed)
- cardiovascular disease, cancer, pregnancy, arthritis, diabetes, claustrophobia, Reynaud's disease, osteoporosis, neuropathy.
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 |
|---|---|---|
| Isometric ExerciseParticipants will be asked to hold a submaximal voluntary contraction of the quadriceps muscle as long as they can (task failure). | Other | Isometric Exercise |
Primary outcome
Conditioned Pain Modulation
Time frame: baseline, immediately after exercise or quiet rest
the change in pressure pain threshold (kPa) during or after the immersion of the foot in a cold water bath (approximately 6 degrees) compared with baseline (before foot submersion) constitutes the measure of conditioned pain modulation in this study.
1 secondary outcome
Vibration Perception Threshold
Time frame: baseline, immediately after exercise or quiet rest
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 24 Feb 2021.
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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.
Marie Hoeger Bement, PT, PhD principal investigator
Marquette University
Ali Alsouhibani, PT, MS study director
Marquette University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric Exercise in people with Fibromyalgia, run by Marquette University at 1 site in United States.
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 1 inclusion and 1 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 24 Feb 2021. 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 States. 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?
Conditioned Pain Modulation (time frame: baseline, immediately after exercise or quiet rest). 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 24 Feb 2021.