Exercise-induced Muscle DamageNCT03160937
Neurodynamic Mobilization and Foam Rolling
A study testing Manual therapy in people with Exercise-induced Muscle Damage and Movement Disorders, run by Centro Universitario La Salle.
Trial summary
The purpose of this study was to assess the acute effects of a single NM treatment session on DOMS and to compare them with those of one foam roller (FR) session. Following the damaging plyometric exercise bout, the participants were randomly assigned in a counter-balanced fashion to either a FR or NM treatment group… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise-induced Muscle Damage, Movement Disorders, Nerve Pain
- What is being tested?
- Manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2017to 10 Apr 2017
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All subjects were moderately active (Category 2) as assessed by the International Physical Activity Questionnaire (IPAQ) questionnaire (Craig et al., 2003).
- None of the subjects had a recent history of intensive training, heavy eccentric resistance, or plyometric exercise, and all subjects were free from musculoskeletal disorders in the last year.
- All subjects were asked to refrain from unaccustomed exercise during the experimental period, and the subjects abstained from all medications and dietary supplements during the experimental period and between testing sessions.
Who cannot join
- Sedentary
- patients with pain
About this study
Official title: Neurodynamic Mobilization and Foam Rolling in Delayed-onset Muscle Soreness in a Healthy Adult Population: a Randomized Controlled Clinical Trial
The purpose of this study was to assess the acute effects of a single NM treatment session on DOMS and to compare them with those of one foam roller (FR) session. Following the damaging plyometric exercise bout, the participants were randomly assigned in a counter-balanced fashion to either a FR or NM treatment group; treatments were administered 48-h post-exercise. The dependent variables were recorded before the exercise, 48-h post-exercise before treatment, and immediately post-treatment.
Read the detailed description
Currently, the foam-rolling massage is often used by athletes from many sports. However, there are a few studies on the effects of foam-rolling massage and they have conflicting results regarding the improvements in ROM and muscular performance. In contrast, neurodynamic mobilization (NM) is a manual therapy method used to assess and treat neuromuscular disorders. It includes gliding techniques and tensile techniques. Gliding techniques or "sliders" are intended to produce a sliding movement between neural structures and adjacent nonneural tissues. NM has been shown to reduce pain and soreness and improve ROM. However, no studies have investigated its effects after exercise-induced muscle soreness or DOMS.
- Being tested
- Manual therapy
- Keywords
- pain
- Medical subject headings
- Movement Disorders, Neuralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
The subjects repeated this motion for 1 min, rested for 30 s, and then repeated it again for 5 sets.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy Foam | Experimental | The subjects included rolled the foam roller down their quadriceps using short kneading-like motions until it was just above their patellae, and then rolled it back to its initial position in one fluid motion. The subjects repeated this motion for 1 min, rested for 30 s, and then repeated it again for 5 sets Receives: Other: Manual therapy |
| Manual therapy Nerve | Active comparator | The subjects was positioned lying on his/her side with a pillow underside leg (without fully flexing it) and the cervical and thoracic spines flexed. The investigator flex the knee and the hip extended and then put it back to its initial position in one fluid motion. The subjects repeated this motion for 1 min, rested for 30 s, and then repeated it again for 5 sets Receives: Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
the numeric pain-rating scale (NPRS)
Measured: 1 minute after treatment
Secondary outcomes (2)
Leg dynamometer measurements
Leg strength
Measured: 2 minutes after treatment
Surface electromyography (sEMG)
EMG of quadriceps muscle
Measured: 5 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start10 Jan 2017
- Primary completion10 Mar 2017
- Study completion10 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise-induced Muscle DamageStudies 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
- Parallel groups
- Model description
- a single NM treatment session on Delayed Onset Muscle pain (DOMS) and to compare them with those of one foam roller (FR) session
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario La Salle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Muñoz-Garcia, Centro Universitario La Salle
- Investigators
- Daniel Muñoz, PhD, Principal investigator, Centro Universitario La Salle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160937
- Sponsor's protocol ID
- CSEULS-PI-009/2013
- Status last verified
- May 2017
- First submitted
- 13 May 2017
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodynamic Mobilization and Foam Rolling in Delayed-onset Muscle Soreness in a Healthy Adult Population: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03160937
- Acronym / sponsor ID
- CSEULS-PI-009/2013
- Keywords
- pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Centro Universitario La SalleUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- 10 Apr 2017 (actual)
- First posted
- 19 May 2017 (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 was to assess the acute effects of a single NM treatment session on DOMS and to compare them with those of one foam roller (FR) session. Following the damaging plyometric exercise bout, the participants were randomly assigned in a counter-balanced fashion to either a FR or NM treatment group; treatments were administered 48-h post-exercise. The dependent variables were recorded before the exercise, 48-h post-exercise before treatment, and immediately post-treatment.
Detailed description
Currently, the foam-rolling massage is often used by athletes from many sports. However, there are a few studies on the effects of foam-rolling massage and they have conflicting results regarding the improvements in ROM and muscular performance. In contrast, neurodynamic mobilization (NM) is a manual therapy method used to assess and treat neuromuscular disorders. It includes gliding techniques and tensile techniques. Gliding techniques or "sliders" are intended to produce a sliding movement between neural structures and adjacent nonneural tissues. NM has been shown to reduce pain and soreness and improve ROM. However, no studies have investigated its effects after exercise-induced muscle soreness or DOMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- a single NM treatment session on Delayed Onset Muscle pain (DOMS) and to compare them with those of one foam roller (FR) session
| Arm | Type | Receives |
|---|---|---|
| Manual therapy Foam | Experimental | Other: Manual therapyThe subjects included rolled the foam roller down their quadriceps using short kneading-like motions until it was just above their patellae, and then rolled it back to its initial position in one fluid motion. The subjects repeated this motion for 1 min, rested for 30 s, and then repeated it again for 5 sets |
| Manual therapy Nerve | Active comparator | Other: Manual therapyThe subjects was positioned lying on his/her side with a pillow underside leg (without fully flexing it) and the cervical and thoracic spines flexed. The investigator flex the knee and the hip extended and then put it back to its initial position in one fluid motion. The subjects repeated this motion for 1 min, rested for 30 s, and then repeated it again for 5 sets |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All subjects were moderately active (Category 2) as assessed by the International Physical Activity Questionnaire (IPAQ) questionnaire (Craig et al., 2003).
- None of the subjects had a recent history of intensive training, heavy eccentric resistance, or plyometric exercise, and all subjects were free from musculoskeletal disorders in the last year.
- All subjects were asked to refrain from unaccustomed exercise during the experimental period, and the subjects abstained from all medications and dietary supplements during the experimental period and between testing sessions.
Key exclusion criteria (2 listed)
- Sedentary
- patients with pain
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 |
|---|---|---|
| Manual therapyThe subjects repeated this motion for 1 min, rested for 30 s, and then repeated it again for 5 sets. | Other | Manual therapy Foam, Manual therapy Nerve |
Primary outcome
Pain
Time frame: 1 minute after treatment
the numeric pain-rating scale (NPRS)
2 secondary outcomes
Leg dynamometer measurements
Time frame: 2 minutes after treatment
Surface electromyography (sEMG)
Time frame: 5 minutes after treatment
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 19 May 2017.
- Individual participant dataSharing planned: No
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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.
Daniel Muñoz, PhD principal investigator
Centro Universitario La Salle
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy in people with Exercise-induced Muscle Damage and Movement Disorders, run by Centro Universitario La Salle.
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 3 inclusion and 2 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 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain (time frame: 1 minute after treatment). 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 19 May 2017.