| Condition or disease |
|---|
| Musculoskeletal Pain Healthy Delayed Onset Muscle Soreness |
The aim of this study is to determine how is the normalization process of sensory (pressure pain thresholds, subjective pain sensation, self-recovery perception), motor (maximal isometric strength, active range of motion, manual dexterity) and tissue (myotonometer) variables after an experimental pain model in the extensor forearms muscles, by delayed onset muscle soreness after an eccentric exercise in healthy subjects. This way will be possible to establish 1) if there are differences in the time of normalization for each variable; 2) if there is a correlation between each variable and self-recovery perception.
Seven assessment sessions are performed in a 14-days period. Day 0 (baseline assessment 1), Day 7 (baseline assessment 2, pre exercise), Day 7 (post exercise), Day 8 (24-hours post exercise), Day 9 (48-hours post exercise), Day 10 (72-hours post exercise), Day 14 (1-week post exercise).
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 30 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 14 Days |
| Official Title: | Temporal Relationship in Recovery of Sensory, Motor and Tissue Variables in an Experimental Exercise-induced Muscle Pain Model of the Wrist Extensor Muscles |
| Actual Study Start Date : | February 4, 2019 |
| Actual Primary Completion Date : | December 13, 2019 |
| Actual Study Completion Date : | December 20, 2019 |
| Group/Cohort |
|---|
|
Healthy subjects
Participants free from any pain specific to the upper limb during the past 3 months, chronic pain or other disease.
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria:
| Spain | |
| Universidad San Jorge | |
| Villanueva de Gállego, Zaragoza, Spain, 50830 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | July 2, 2019 | ||||
| First Posted Date | July 9, 2019 | ||||
| Last Update Posted Date | November 10, 2020 | ||||
| Actual Study Start Date | February 4, 2019 | ||||
| Actual Primary Completion Date | December 13, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
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| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Multivariable Recovery After Exercise-induced Muscle Pain in the Forearm Muscles | ||||
| Official Title | Temporal Relationship in Recovery of Sensory, Motor and Tissue Variables in an Experimental Exercise-induced Muscle Pain Model of the Wrist Extensor Muscles | ||||
| Brief Summary | This study investigates the evolution of sensory, motor and tissue variables following exercise-induced pain in wrist extensor muscles in healthy subjects. | ||||
| Detailed Description |
The aim of this study is to determine how is the normalization process of sensory (pressure pain thresholds, subjective pain sensation, self-recovery perception), motor (maximal isometric strength, active range of motion, manual dexterity) and tissue (myotonometer) variables after an experimental pain model in the extensor forearms muscles, by delayed onset muscle soreness after an eccentric exercise in healthy subjects. This way will be possible to establish 1) if there are differences in the time of normalization for each variable; 2) if there is a correlation between each variable and self-recovery perception. Seven assessment sessions are performed in a 14-days period. Day 0 (baseline assessment 1), Day 7 (baseline assessment 2, pre exercise), Day 7 (post exercise), Day 8 (24-hours post exercise), Day 9 (48-hours post exercise), Day 10 (72-hours post exercise), Day 14 (1-week post exercise). |
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| Study Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 14 Days | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Healthy young-adults free of pain or disease and without history of severe injury. | ||||
| Condition |
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Healthy subjects
Participants free from any pain specific to the upper limb during the past 3 months, chronic pain or other disease.
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
30 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Actual Study Completion Date | December 20, 2019 | ||||
| Actual Primary Completion Date | December 13, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 50 Years (Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Spain | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04012203 | ||||
| Other Study ID Numbers | PI18/385 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Universidad San Jorge | ||||
| Study Sponsor | Universidad San Jorge | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Universidad San Jorge | ||||
| Verification Date | November 2020 | ||||