Pain, MuscleNCT03942562

Temporal Relationship in Recovery of Muscular Pain and Functional Variables in an Experimental Muscular Pain Model in Hamstrings

An observational study of Pain, Muscle, run by Universidad San Jorge at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Basal measurements are taken in relation to the study variables. Immediately subjects perform eccentric exercise on right hamstrings to develop delayed onset muscle soreness (DOMS). Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Pain, Muscle
How many people: 24 participants
Where: 1 siteSpain
Study dates: 15 Oct 2018to 31 Aug 2019
How long will I take part?: 7 Days
Phase: Observational
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 45 years
Men only
Healthy volunteers accepted
Adult

Study population: Non sedentary healthy men

Who may be able to join

not sedentary subject (IPAQ scale > 600 MET)
healthy subjects, without pain nor injury at the moment

Who cannot join

subjects with acute or chronic pain on every spot of pelvis or lower limbs at the momento or for the last 3 months;
subjects with history of severe injury in the hamstrings muscles;
presence of serious illness;
presence of pathologies in relation to chronic pain (as fibromyalgia, migraine disorders, non specific and chronic lumbar pain);
not commitment for continuity in the study program;

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universidad San Jorge
Villanueva de Gállego, Zaragoza, 50830

Other trials in Spain

About this study

Official title: Temporal Relationship in Recovery of Muscular Pain, Functional Variables and Normal Gait Pattern in an Experimental Muscular Pain Model in Hamstrings

Basal measurements are taken in relation to the study variables. Immediately subjects perform eccentric exercise on right hamstrings to develop delayed onset muscle soreness (DOMS).

Measurements of the study variables are taken in the same conditions 48, 96 and 168 hours after the exercise to study the evolution of the variables while recovering from DOMS.

Read the detailed description

Basal measurements are taken in relation to the study variables.

The variables are:

pressure pain thresholds
electromyography values
static and dynamic plantar pressure measurement
active knee extensibility
maximal strength of knee flexors
thermography
scales of pain perception

Immediately subjects perform eccentric exercise on right hamstrings to develop DOMS (delay onset muscle soreness).

Measurements of the study variables are taken in the same conditions 48, 96 and 168 hours after the exercise to study the evolution of the variables while recovering from DOMS.

Conditions: Pain, Muscle
Keywords: DOMS, Healthy subjects, Pressure pain thresholds, Active Knee Extension test, Maximal strength, Electromyography, Plantar pressure measurement, Gait analysis
Medical subject headings: Myalgia

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in spatio temporal parameters of gait
Changes in spatio temporal parameters of gait over a treadmill will be measurement using an optical measurement system consisting of a transmitting and receiving bar (OptoGait System).
Measured: Baseline, 48 hours, 96 hours, 1 week

Secondary outcomes (7)

Changes in Pressure Pain Thresholds
Changes in pressure pain thresholds (PPT) will be determined with pressure algometry bilaterally over the leg and shoulder. PPT is defined as the exact time point where the pressure is first being perceived at painful.
Measured: Baseline, 48 hours, 96 hours, 1 week
Changes in active knee extension test
Changes in range of motion (°; degrees) will be assessed in both sides using the active knee extension (AKE) test.
AKE test: subject is lying prone with hip and knee flexed at 90°. Then, maximal knee extension is performed.
Measured: Baseline, 48 hours, 96 hours, 1 week
Changes in knee-flexors maximal isometric muscle strength
Changes in knee-flexors maximal isometric strength (Newton) will be assessed by using a hand-held dynamometer.
Measured: Baseline, 48 hours, 96 hours, 1 week
Electromyography (EMG) measurement during the tests
Electromyography values will be taken from hamstrings during the performance of gait analysis and dynamometry
Measured: Baseline, 48 hours, 96 hours, 1 week
Changes in thermography on hamstrings areas
A thermography image will be taken every day of assessment. Changes in colour pixels will be analysed to determine temperature changes.
Measured: Baseline, 48 hours, 96 hours, 1 week
Changes in static and dynamic plantar pressure measurement
Changes in static and dynamic plantar pressure measurement will be performed in every session by using a pressure platform.
Measured: Baseline, 48 hours, 96 hours, 1 week
Changes in subjective perception of pain and impairment: Two questionnaire (Modified 7-item Likert Scales)
Two questionnaires (Modified 7-item Likert Scales) are filled up by the subject to show subjective perception of pain related to movement along the recovery period.
Scale of pain intensity, from 0 (no pain) to 6 (higher pain intensity). Scale of functional impairment, from 0 (no impairment) to 6 (higher impairment).
Measured: 48 hours, 96 hours, 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 201831 Aug 2019

First posted8 May 2019
Study start15 Oct 2018
Primary completion31 Aug 2019
Study completion31 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pain, MuscleStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 24 participants (actual)
Target duration: 7 Days

IDs, dates and publications

ClinicalTrials.gov ID: NCT03942562
Sponsor's protocol ID: PI18/208
Status last verified: Nov 2020
First submitted: 6 May 2019
Last updated: 10 Nov 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: We don't plan to share data collected

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pain, Muscle trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Temporal Relationship in Recovery of Muscular Pain, Functional Variables and Normal Gait Pattern in an Experimental Muscular Pain Model in Hamstrings
ClinicalTrials.gov ID: NCT03942562
Acronym / sponsor ID: PI18/208
Conditions: Pain, Muscle
Keywords: DOMS, Healthy subjects, Pressure pain thresholds, Active Knee Extension test, Maximal strength, Electromyography, Plantar pressure measurement, Gait analysis
Study type: Observational
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Universidad San JorgeUniversity, hospital or other
Study start: 15 Oct 2018 (actual)
Primary completion: 31 Aug 2019 (actual)
Study completion: 31 Aug 2019 (actual)
First posted: 8 May 2019 (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.

Basal measurements are taken in relation to the study variables. Immediately subjects perform eccentric exercise on right hamstrings to develop delayed onset muscle soreness (DOMS).

Measurements of the study variables are taken in the same conditions 48, 96 and 168 hours after the exercise to study the evolution of the variables while recovering from DOMS.

Detailed description

Basal measurements are taken in relation to the study variables.

The variables are:

pressure pain thresholds
electromyography values
static and dynamic plantar pressure measurement
active knee extensibility
maximal strength of knee flexors
thermography
scales of pain perception

Immediately subjects perform eccentric exercise on right hamstrings to develop DOMS (delay onset muscle soreness).

Measurements of the study variables are taken in the same conditions 48, 96 and 168 hours after the exercise to study the evolution of the variables while recovering from DOMS.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 7 Days

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult
Study population: Non sedentary healthy men

Key inclusion criteria (2 listed)

not sedentary subject (IPAQ scale > 600 MET)
healthy subjects, without pain nor injury at the moment

Key exclusion criteria (5 listed)

subjects with acute or chronic pain on every spot of pelvis or lower limbs at the momento or for the last 3 months;
subjects with history of severe injury in the hamstrings muscles;
presence of serious illness;
presence of pathologies in relation to chronic pain (as fibromyalgia, migraine disorders, non specific and chronic lumbar pain);
not commitment for continuity in the study program;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Changes in spatio temporal parameters of gait
Time frame: Baseline, 48 hours, 96 hours, 1 week
Changes in spatio temporal parameters of gait over a treadmill will be measurement using an optical measurement system consisting of a transmitting and receiving bar (OptoGait System).

7 secondary outcomes

Changes in Pressure Pain Thresholds
Time frame: Baseline, 48 hours, 96 hours, 1 week
Changes in active knee extension test
Time frame: Baseline, 48 hours, 96 hours, 1 week
Changes in knee-flexors maximal isometric muscle strength
Time frame: Baseline, 48 hours, 96 hours, 1 week
Electromyography (EMG) measurement during the tests
Time frame: Baseline, 48 hours, 96 hours, 1 week
Changes in thermography on hamstrings areas
Time frame: Baseline, 48 hours, 96 hours, 1 week
Changes in static and dynamic plantar pressure measurement
Time frame: Baseline, 48 hours, 96 hours, 1 week
Changes in subjective perception of pain and impairment: Two questionnaire (Modified 7-item Likert Scales)
Time frame: 48 hours, 96 hours, 1 week

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 10 Nov 2020.
Individual participant dataSharing planned: No. We don't plan to share data collected

Related trials for Pain, Muscle

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Not yet recruiting
Effects of IASTM, Deep Friction Massage, and Sham Instrument-Assisted Soft Tissue Mobilization on Electromyographical Activation, Pain and Function in Non-Specific Low Back Pain
Low Back Pain, Trigger Point Pain, Myofascial
Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult

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.

Víctor Doménech, MSc study director

Universidad San Jorge

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pain, Muscle, run by Universidad San Jorge at 1 site in Spain.

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 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 10 Nov 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 Spain. 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?

Changes in spatio temporal parameters of gait (time frame: Baseline, 48 hours, 96 hours, 1 week). 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 NCT03942562.

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 10 Nov 2020.