FibromyalgiaNCT03778385
Influence of Exercise Type, Pain Mechanisms, and Biopsychosocial Contributions to Pain Relief in Those With Fibromyalgia
A study testing Exercise in people with Fibromyalgia, run by Marquette University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the influence different types of exercise, pain mechanisms, and biopsychosocial contributions on how people with and without fibromyalgia report pain. Exercise will be performed with the arm at a submaximal intensity. 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?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2017to Jan 2023
- 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
- Fibromyalgia
- Healthy Controls without fibromyalgia
- Stable medical management plan for four weeks prior to participation in the study.
- Physical Activity Readiness Questionnaire (PAR-Q)
- English proficiency
Who cannot join
- Elbow arthritis
- Carpal tunnel syndrome
- Cervical surgery
- Cerebrovascular accident / stroke
- Multiple sclerosis
- Parkinson's disease
Show all 24Show fewer
- Any central neurodegenerative disease
- Traumatic brain injury
- Peripheral neuropathy of the upper extremity
- Myocardial infarction
- Chronic obstructive pulmonary disease
- Any unstable medical or psychiatric condition
- Diabetes mellitus
- Active cancer
- Lymphedema of the upper extremity
- Claustrophobia
- Raynaud's phenomenon
- Osteoporosis
- Major depressive disorder
- Bipolar disorder
- Rheumatoid arthritis
- Lupus
- Polymyalgia rheumatica
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Specificity and Endogenous Pain Modulation
The purpose of this study is to investigate the influence different types of exercise, pain mechanisms, and biopsychosocial contributions on how people with and without fibromyalgia report pain. Exercise will be performed with the arm at a submaximal intensity. Participants will undergo a variety of pain assessments, including clinical questionnaires and pain perception. This study will improve our understanding of how people with and without fibromyalgia respond to different resistance exercise types and whether physical activity and body composition has an influence on the response.
Read the detailed description
Fibromyalgia is a chronic widespread pain condition that is mostly prevalent in middle-aged women. Exercise is one of the few therapies that can alleviate fibromyalgia symptoms. Despite exercise being a major component of rehabilitation, exercise guidelines are unclear, often leading to symptom exacerbation and low compliance. Previous research has demonstrated that women with fibromyalgia may have different post-exercise pain responses when undergoing an exercise task. Factors critical to optimal exercise prescription are not known, including the most effective type of exercise, mechanisms responsible for pain relief, and biopsychosocial influences. This study investigates the use of exercise as a nonpharmacological pain management tool for people with fibromyalgia.
The purpose of this study is to investigate the acute exercise-induced pain response after isometric and dynamic muscle contractions in people with and without fibromyalgia. All participants will attend up to three sessions with approximately one week between sessions at a metropolitan university laboratory setting. Participants will perform different types of submaximal exercise for a maximum of ten minutes and complete pain assessments each session. Pain and psychosocial influences are measured with multiple established clinical questionnaires. Pressure pain sensitivity is tested by application of a mechanical stimulus to the arms and legs. To investigate a participant's innate ability to inhibit pain, the mechanical stimulus will be assessed with and without limb submersion in a cold-water bath. Physical activity is measured via questionnaire and use of activity monitors, while body composition is measured with a dual energy x-ray absorptiometry scan.
- Conditions
- Fibromyalgia
- Being tested
- Exercise
- Keywords
- Fibromyalgia, Exercise, Pain, Physical Activity, Body Composition
- Medical subject headings
- Fibromyalgia, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Submaximal exercise is performed in randomized order with the participant seated and the arm supported in an adjustable hand-arm orthosis.
| Study group | Role | What they receive |
|---|---|---|
| Isometric Exercise | Experimental | Submaximal isometric resistance exercise of the arm. Receives: Other: Exercise |
| Dynamic Exercise | Experimental | Submaximal dynamic resistance exercise of the arm. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Short-Form McGill Pain Questionnaire to 7-days after performance of exercise.
The Short-Form McGill Pain Questionnaire is a multi-dimensional tool to assess pain quality in chronic pain patients. Participants rate the intensity of pain and related symptoms they felt during the past week on 0 to 3 scale, with 0 being no pain and 3 being severe. The total score ranges from a minimum of 0 to maximum 45 with higher scores indicating worse symptoms.
Measured: Before and up to 7-days after performance of exercise.
Change from Baseline Fibromyalgia Impact Questionnaire to 7-days after performance of exercise.
The Fibromyalgia Impact Questionnaire - Revised measures function, overall impact, and symptoms of fibromyalgia. Participants rate the difficulty in performing daily tasks, the impact of their symptoms, and intensity of fibromyalgia symptoms on a 0 to 10 scale, with 10 signifying greater significance. The total score ranges from a minimum of 0 to maximum of 210 with higher scores indicating worse function and symptoms.
Measured: Before and up to 7-days after performance of exercise.
Change from Baseline Pain Rating from a Pressure Pain Device to immediately after performance of exercise.
Application of mechanical stimulus through a weighted Lucite edge will be applied to the finger for a maximal duration of 2 minutes. Subjects will provide a pain rating every 20 seconds during the 2-minute test. Pain ratings are provided with use of a Numerical Pain Rating Scale that ranges from 0 (no pain) to 10 (worst pain).
Measured: Before and immediately after performance of exercise.
Change from Baseline Pressure Pain Threshold to immediately after performance of exercise.
Application of a pressure stimulus is applied to the bicep muscle and quadriceps muscle at a rate of 50kPa per second until the pressure first becomes painful.
Measured: Before and immediately after exercise.
Change from Baseline Numerical Pain Rating Scale to 7-days after performance of exercise.
Pain in the exercising limb and whole body will be reported. Pain ratings are provided with use of a Numerical Pain Rating Scale that ranges from 0 (no pain) to 10 (worst pain).
Measured: Before, during, and up to 7-days after performance of exercise.
Change in Pain Catastrophizing before to after exercise.
Measures the exaggerated negative mental set brought to bear during an actual or anticipated painful experience. Measured with the Pain Catastrophizing Scale which has subscales of rumination, magnification, and helplessness. Rumination scale ranges from 0 to 16 with higher score indicating higher levels of rumination. Magnification scale ranges from 0 to 12 with higher scores indicating higher levels of magnification. Helplessness scale ranges from 0 to 24 with higher scores indicating higher levels of helplessness. The subscale scores are summed to compute a total score ranging from 0 to 52 with higher scores indicating higher levels of pain catastrophizing.
Measured: Through study completion, an average of 3 weeks.
Baseline Tampa Scale of Kinesiophobia - 11
Measures pain-related fear in relation to movement or avoidance type behaviors. A total score is computed ranging from 0 to 44 with higher scores indicating higher levels of pain-related fear.
Measured: At the beginning of each session.
Change from Baseline PROMIS Short Form v1.0 - Fatigue 7a at completion of study.
Measures the experience and impact of fatigue on daily activity. The PROMIS Short Form v1.0 - Fatigue 7a measures subjective feelings of tiredness to a sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Participants rank the level of tiredness on a scale of 1 (never) to 5 (always). The total score ranges from 7 to 35 with 35 indicating greater levels of exhaustion that impacts ability to perform daily tasks.
Measured: At the beginning of each exercise session.
American College of Rheumatology Diagnostic Criteria for Fibromyalgia
Questionnaire characterizing the symptoms of those with fibromyalgia. The scale is composed of 3 subscales; widespread pain index, symptom severity score A and B. The widespread pain index ranges from 0 to 19 with 19 indicating greater number of body areas in which pain was experienced. The symptom severity score A ranges from 0 to 9 with 9 indicating greater symptom severity. The symptom severity score B ranges from 0 to 3 with 3 indicating greater number of symptoms experienced. The total Symptom Severity Score is calculated by adding symptom severity score A and symptom severity score B with a total range of 0 (no symptoms) to 12 (great deal of symptoms).
Measured: At the beginning of each session.
Conditioned Pain Modulation
The difference in pressure pain (measured via pressure algometry) at the biceps and quadriceps with and without the subject's limb placed in an ice water bath.
Measured: Day 1 of enrollment
Physical Activity Assessment Tool
The Physical Activity Assessment Tool estimates the amount of physical activity performed and perceptions towards participation in physical activity. The total amount of time per day (minutes/day) is calculated for time spent in moderate to vigorous physical activity. With 0 minutes indicating no time spent in moderate to vigorous physical activity and higher values indicating greater time spent in moderate to vigorous physical activity.
Measured: Up to 7 days.
Total time spent in sedentary and moderate to vigorous physical activity measured by an Actigraph wGT3x over the course of 7 days.
An Actigraph wGT3x is a wrist worn device that is used to track the amount and intensity of physical activity performed over the course of seven days. Total time spent in sedentary and moderate to vigorous physical activity is measured in minutes.
Measured: Worn continuously for a 7-day period during study enrollment.
Baseline Lean Mass
Measurement of lean mass with use of dual energy x-ray absorptiometry testing.
Measured: 7 to 14 days after enrollment.
Baseline Fat Mass
Measurement of fat mass with use of dual energy x-ray absorptiometry testing.
Measured: 7 to 14 days after enrollment.
Secondary outcomes (8)
Change from Baseline Maximal Voluntary Force to immediately after performance of exercise.
Maximal force produced with the arm when performing a bending motion of the elbow. Maximal torque is measured with an isokinetic dynamometer with higher levels indicating greater amount of force.
Measured: Before and immediately after performance of exercise.
Baseline voluntary muscle activation of the biceps muscle
Assess each subject's ability to voluntarily activate their bicep muscle when performing a maximal voluntary contraction of the elbow flexors. Participants will generate maximal force from their elbow flexors with application of muscle stimulation. Muscle stimulation is provided via electrodes placed on the skin overlying the biceps muscle and activation of the muscle will be achieved by a constant-current stimulator. Force is recorded via isokinetic dynamometry. To assess voluntary activation, a single twitch will be interpolated during the plateau of the maximal voluntary contraction force by the stimulator.
Measured: Through study completion, an average of 3 weeks.
Change from Baseline Heart Rate to immediately after performance of exercise.
Heart rate is measured with an automated cuff applied to the wrist.
Measured: Measured before, during, and immediately after exercise.
Change from Baseline Blood Pressure to immediately after performance of exercise.
Blood pressure is measured with an automated cuff applied to the wrist.
Measured: Measured before, during, and immediately after exercise.
Change from Baseline Rating of Perceived Exertion to immediately after performance of exercise
Rating of Perceived Exertion refers to the total amount of exertion a participant is feeling and measured with a modified BORG scale ranging from 0 (nothing) to 10 (maximal exertion).
Measured: Measured before, during, and immediately after exercise.
Baseline sensory threshold assessed with von Frey monofilaments
Monofilaments will be applied perpendicular to the skin in ascending order, the lowest-size filament to induce sensation is recorded.
Measured: At the beginning of each session.
Change from baseline pain unpleasantness up to 7 days after exercise.
Unpleasantness in the exercising limb will be reported with a 0-10 numerical rating scale.
Measured: Before, during, and up to 7-days after performance of exercise.
Change from baseline PROMIS Short Form v1.0 Pain Interference 6b up to 7 days after exercise.
A 6-item questionnaire will help measure interference of pain on functional daily activity.
Measured: Before, during, and up to 7-days after performance of exercise.
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 start3 Feb 2017
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- All subjects will participate in two randomized exercise sessions. Clinical and experimental pain assessment will be performed before, during, and after each exercise task.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Marie K Hoeger Bement, PT, PhD, Principal investigator, Marquette University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778385
- Sponsor's protocol ID
- HR-3035
- Other IDs
- R15HD090265, TL1TR001437, UL1TR001436
- Status last verified
- Jun 2022
- First submitted
- 12 Dec 2018
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berardi G, Eble C, Hunter SK, Bement MH. Localized Pain and Fatigue During Recovery From Submaximal Resistance Exercise in People With Fibromyalgia. Phys Ther. 2023 Jun 5;103(6):pzad033. doi: 10.1093/ptj/pzad033.
PubMed 37384640
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Specificity and Endogenous Pain Modulation
- ClinicalTrials.gov ID
- NCT03778385
- Acronym / sponsor ID
- HR-3035
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Exercise, Pain, Physical Activity, Body Composition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- 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 investigate the influence different types of exercise, pain mechanisms, and biopsychosocial contributions on how people with and without fibromyalgia report pain. Exercise will be performed with the arm at a submaximal intensity. Participants will undergo a variety of pain assessments, including clinical questionnaires and pain perception. This study will improve our understanding of how people with and without fibromyalgia respond to different resistance exercise types and whether physical activity and body composition has an influence on the response.
Detailed description
Fibromyalgia is a chronic widespread pain condition that is mostly prevalent in middle-aged women. Exercise is one of the few therapies that can alleviate fibromyalgia symptoms. Despite exercise being a major component of rehabilitation, exercise guidelines are unclear, often leading to symptom exacerbation and low compliance. Previous research has demonstrated that women with fibromyalgia may have different post-exercise pain responses when undergoing an exercise task. Factors critical to optimal exercise prescription are not known, including the most effective type of exercise, mechanisms responsible for pain relief, and biopsychosocial influences. This study investigates the use of exercise as a nonpharmacological pain management tool for people with fibromyalgia.
The purpose of this study is to investigate the acute exercise-induced pain response after isometric and dynamic muscle contractions in people with and without fibromyalgia. All participants will attend up to three sessions with approximately one week between sessions at a metropolitan university laboratory setting. Participants will perform different types of submaximal exercise for a maximum of ten minutes and complete pain assessments each session. Pain and psychosocial influences are measured with multiple established clinical questionnaires. Pressure pain sensitivity is tested by application of a mechanical stimulus to the arms and legs. To investigate a participant's innate ability to inhibit pain, the mechanical stimulus will be assessed with and without limb submersion in a cold-water bath. Physical activity is measured via questionnaire and use of activity monitors, while body composition is measured with a dual energy x-ray absorptiometry scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All subjects will participate in two randomized exercise sessions. Clinical and experimental pain assessment will be performed before, during, and after each exercise task.
| Arm | Type | Receives |
|---|---|---|
| Isometric Exercise | Experimental | Other: ExerciseSubmaximal isometric resistance exercise of the arm. |
| Dynamic Exercise | Experimental | Other: ExerciseSubmaximal dynamic resistance exercise of the arm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fibromyalgia
- Healthy Controls without fibromyalgia
- Stable medical management plan for four weeks prior to participation in the study.
- Physical Activity Readiness Questionnaire (PAR-Q)
- English proficiency
Key exclusion criteria (24 listed)
- Elbow arthritis
- Carpal tunnel syndrome
- Cervical surgery
- Cerebrovascular accident / stroke
- Multiple sclerosis
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 |
|---|---|---|
| ExerciseSubmaximal exercise is performed in randomized order with the participant seated and the arm supported in an adjustable hand-arm orthosis. | Other | Dynamic Exercise, Isometric Exercise |
Primary outcome
Change from Baseline Short-Form McGill Pain Questionnaire to 7-days after performance of exercise.
Time frame: Before and up to 7-days after performance of exercise.
The Short-Form McGill Pain Questionnaire is a multi-dimensional tool to assess pain quality in chronic pain patients. Participants rate the intensity of pain and related symptoms they felt during the past week on 0 to 3 scale, with 0 being no pain and 3 being severe. The total score ranges from a minimum of 0 to maximum 45 with higher scores indicating worse symptoms.
Change from Baseline Fibromyalgia Impact Questionnaire to 7-days after performance of exercise.
Time frame: Before and up to 7-days after performance of exercise.
The Fibromyalgia Impact Questionnaire - Revised measures function, overall impact, and symptoms of fibromyalgia. Participants rate the difficulty in performing daily tasks, the impact of their symptoms, and intensity of fibromyalgia symptoms on a 0 to 10 scale, with 10 signifying greater significance. The total score ranges from a minimum of 0 to maximum of 210 with higher scores indicating worse function and symptoms.
Change from Baseline Pain Rating from a Pressure Pain Device to immediately after performance of exercise.
Time frame: Before and immediately after performance of exercise.
Application of mechanical stimulus through a weighted Lucite edge will be applied to the finger for a maximal duration of 2 minutes. Subjects will provide a pain rating every 20 seconds during the 2-minute test. Pain ratings are provided with use of a Numerical Pain Rating Scale that ranges from 0 (no pain) to 10 (worst pain).
Change from Baseline Pressure Pain Threshold to immediately after performance of exercise.
Time frame: Before and immediately after exercise.
Application of a pressure stimulus is applied to the bicep muscle and quadriceps muscle at a rate of 50kPa per second until the pressure first becomes painful.
Change from Baseline Numerical Pain Rating Scale to 7-days after performance of exercise.
Time frame: Before, during, and up to 7-days after performance of exercise.
Pain in the exercising limb and whole body will be reported. Pain ratings are provided with use of a Numerical Pain Rating Scale that ranges from 0 (no pain) to 10 (worst pain).
Change in Pain Catastrophizing before to after exercise.
Time frame: Through study completion, an average of 3 weeks.
Measures the exaggerated negative mental set brought to bear during an actual or anticipated painful experience. Measured with the Pain Catastrophizing Scale which has subscales of rumination, magnification, and helplessness. Rumination scale ranges from 0 to 16 with higher score indicating higher levels of rumination. Magnification scale ranges from 0 to 12 with higher scores indicating higher levels of magnification. Helplessness scale ranges from 0 to 24 with higher scores indicating higher levels of helplessness. The subscale scores are summed to compute a total score ranging from 0 to 52 with higher scores indicating higher levels of pain catastrophizing.
Baseline Tampa Scale of Kinesiophobia - 11
Time frame: At the beginning of each session.
Measures pain-related fear in relation to movement or avoidance type behaviors. A total score is computed ranging from 0 to 44 with higher scores indicating higher levels of pain-related fear.
Change from Baseline PROMIS Short Form v1.0 - Fatigue 7a at completion of study.
Time frame: At the beginning of each exercise session.
Measures the experience and impact of fatigue on daily activity. The PROMIS Short Form v1.0 - Fatigue 7a measures subjective feelings of tiredness to a sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Participants rank the level of tiredness on a scale of 1 (never) to 5 (always). The total score ranges from 7 to 35 with 35 indicating greater levels of exhaustion that impacts ability to perform daily tasks.
American College of Rheumatology Diagnostic Criteria for Fibromyalgia
Time frame: At the beginning of each session.
Questionnaire characterizing the symptoms of those with fibromyalgia. The scale is composed of 3 subscales; widespread pain index, symptom severity score A and B. The widespread pain index ranges from 0 to 19 with 19 indicating greater number of body areas in which pain was experienced. The symptom severity score A ranges from 0 to 9 with 9 indicating greater symptom severity. The symptom severity score B ranges from 0 to 3 with 3 indicating greater number of symptoms experienced. The total Symptom Severity Score is calculated by adding symptom severity score A and symptom severity score B with a total range of 0 (no symptoms) to 12 (great deal of symptoms).
Conditioned Pain Modulation
Time frame: Day 1 of enrollment
The difference in pressure pain (measured via pressure algometry) at the biceps and quadriceps with and without the subject's limb placed in an ice water bath.
Physical Activity Assessment Tool
Time frame: Up to 7 days.
The Physical Activity Assessment Tool estimates the amount of physical activity performed and perceptions towards participation in physical activity. The total amount of time per day (minutes/day) is calculated for time spent in moderate to vigorous physical activity. With 0 minutes indicating no time spent in moderate to vigorous physical activity and higher values indicating greater time spent in moderate to vigorous physical activity.
Total time spent in sedentary and moderate to vigorous physical activity measured by an Actigraph wGT3x over the course of 7 days.
Time frame: Worn continuously for a 7-day period during study enrollment.
An Actigraph wGT3x is a wrist worn device that is used to track the amount and intensity of physical activity performed over the course of seven days. Total time spent in sedentary and moderate to vigorous physical activity is measured in minutes.
Baseline Lean Mass
Time frame: 7 to 14 days after enrollment.
Measurement of lean mass with use of dual energy x-ray absorptiometry testing.
Baseline Fat Mass
Time frame: 7 to 14 days after enrollment.
Measurement of fat mass with use of dual energy x-ray absorptiometry testing.
8 secondary outcomes
Change from Baseline Maximal Voluntary Force to immediately after performance of exercise.
Time frame: Before and immediately after performance of exercise.
Baseline voluntary muscle activation of the biceps muscle
Time frame: Through study completion, an average of 3 weeks.
Change from Baseline Heart Rate to immediately after performance of exercise.
Time frame: Measured before, during, and immediately after exercise.
Change from Baseline Blood Pressure to immediately after performance of exercise.
Time frame: Measured before, during, and immediately after exercise.
Change from Baseline Rating of Perceived Exertion to immediately after performance of exercise
Time frame: Measured before, during, and immediately after exercise.
Baseline sensory threshold assessed with von Frey monofilaments
Time frame: At the beginning of each session.
Change from baseline pain unpleasantness up to 7 days after exercise.
Time frame: Before, during, and up to 7-days after performance of exercise.
Change from baseline PROMIS Short Form v1.0 Pain Interference 6b up to 7 days after exercise.
Time frame: Before, during, and up to 7-days after performance of exercise.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Derived from this study: PubMed 37384640Berardi G, Eble C, Hunter SK, Bement MH. Localized Pain and Fatigue During Recovery From Submaximal Resistance Exercise in People With Fibromyalgia. Phys Ther. 2023 Jun 5;103(6):pzad033. doi: 10.1093/ptj/pzad033.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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 K Hoeger Bement, PT, PhD principal investigator
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 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 5 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 7 Jun 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 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?
Results are not available in the source record.
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?
Change from Baseline Short-Form McGill Pain Questionnaire to 7-days after performance of exercise. (time frame: Before and up to 7-days after performance of exercise.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03778385, which also lists 1 linked publication.
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 7 Jun 2022.