HealthyNCT05725811
Immediate Effects of Myofascial Release on the Quadriceps or Hamstrings on Active Cervical Range of Motion
A study testing Dynamic foam rolling in people with Healthy, run by University Fernando Pessoa at 2 sites in Portugal.
Trial summary
The purpose of this study is to verify the immediate effects of quadriceps or hamstring myofascial release on the active cervical flexion and extension range of motion. Read more about this study
- Who is it for?
- Ages 18 to 37 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dynamic foam rolling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPortugal
- Study dates
- 20 Feb 2023to 11 Apr 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 37 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy university students of both genders with normal mobility of the joints.
Who cannot join
- Deformities in the lower quadrant region of the body;
- Complaints in this region in the last 6 months;
- Surgical procedures or musculoskeletal, cardiac, renal, metabolic, neurological and or oncological pathologies
- Pregnant women
- Ingestion of non-steroidal anti-inflammatory drugs or consumption of any type of narcotic drugs and participants who have drunk alcohol in the last 12 hours.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Immediate Effects of Myofascial Release on the Quadriceps or Hamstrings on Active Cervical Flexion and Extension Range of Motion
The purpose of this study is to verify the immediate effects of quadriceps or hamstring myofascial release on the active cervical flexion and extension range of motion.
Read the detailed description
After completing the questionnaire, 60 healthy college students will be randomly divided into three groups named Intervention Group 1 (IG 1) (n=20), Intervention Group 2 (IG 2) (n=20) and Control Group (CG) (n=20). In the first assessment (M0), the cervical flexion and extension range of motion will be measured with a goniometer. The myofascial release technique (foam roller) will be applied on the hamstrings (IG 1) or quadriceps (IG 2) of the dominant lower limb for 4 minutes (3 series of 1 minute with 30s rest). Participants in the control group will remain at rest sitting in a chair for 4 minutes.
Immediately after the intervention/control, both groups will be assessed, again (M1).
- Conditions
- Healthy
- Being tested
- Dynamic foam rolling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic foam rollingOther
The foam roller will be in contact with the muscle being tested and the patient will exert a load until they feel a slight pain. In this way, the patient performs a self-massage in the direction of the muscle fibers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group 1 | Active comparator | A myofascial release technique will be performed using a foam roller (Blackroll Standard, 30 x 15 cm) on the dominant lower limb.
For the IG 1, the technique will be applied to the hamstrings muscles. In this group, participants will sit on the floor on a mat with the roller under their thighs. Their hands will be placed on the floor with their fingers pointing downwards. The foam roller will be in contact with the muscle being tested and the patient will exert a load until they feel a slight pain. In this way, the patient performs a self-massage in the direction of the muscle fibers. The limb that will not be tested will function as a lever, it will remain bent to the side, which will allow the simple realization of the glide.
A cycle of the procedure will be defined as a proximal to distal rolling movement, so the frequency in this study will be 25 cycles per minute measured with a metronome from a mobile application (Smart Metronome \& Tuner v.11.8 IOS). Receives: Other: Dynamic foam rolling |
| Intervention group 2 | Active comparator | A myofascial release technique will be performed using a foam roller (Blackroll Standard, 30 x 15 cm) on the dominant lower limb.
The IG 2 will perform the same technique on a different muscle group: the quadriceps. In this way, the positioning will be different, the participants will be in the prone position, in a plank position, leaning on the forearms, the body well aligned and the studied lower limb well stretched. However, the participant will also perform a self-massage in the direction of the muscle fibers until they feel slight pain. The duration of the procedure will be set at 4 minutes in this study; 3 rounds of 1 minute (30 s rest).
A cycle of the procedure will be defined as a proximal to distal rolling movement, so the frequency in this study will be 25 cycles per minute measured with a metronome from a mobile application (Smart Metronome \& Tuner v.11.8 IOS). Receives: Other: Dynamic foam rolling |
| Control group | No intervention | The participants will remain at rest in a chair for 4 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of active cervical range of motion in flexion and extension.
Data will be collected in two moments: baseline (M0) and after the intervention/control (M1). Participants will be asked to sit with their spine straight against the back of the chair. The ankles, knees and hips of the subjects will be positioned at right angles and the arms crossed over the chest to minimize thoracic movements.
The position of the goniometer (GIMA, 37.5 x 6.5 x 0.5 cm) will be as follows: the fixed point at the level of the external acoustic meatus, and the mobile arm at the level of the base of the nose (initial position: 90°). The fixed arm will be immobile, parallel to the ear and perpendicular to the ground. Prior to the test, each participant will have performed both movements until the final sensation is reached in order to increase the fluidity of the test. Thus, the first movement asked of the patient will be a flexion followed by an extension (the examiner will take the average of three measurements).
Measured: Change from Baseline (M0) to Immediately after intervention or control (M1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start20 Feb 2023
- Primary completion10 Mar 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Fernando Pessoa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Cardoso, University Fernando Pessoa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725811
- Sponsor's protocol ID
- ESS/FSA-206/22-2
- Status last verified
- May 2023
- First submitted
- 25 Jan 2023
- Last updated
- 18 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Myofascial Release on the Quadriceps or Hamstrings on Active Cervical Flexion and Extension Range of Motion
- ClinicalTrials.gov ID
- NCT05725811
- Acronym / sponsor ID
- ESS/FSA-206/22-2
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Fernando PessoaUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 13 Feb 2023 (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 verify the immediate effects of quadriceps or hamstring myofascial release on the active cervical flexion and extension range of motion.
Detailed description
After completing the questionnaire, 60 healthy college students will be randomly divided into three groups named Intervention Group 1 (IG 1) (n=20), Intervention Group 2 (IG 2) (n=20) and Control Group (CG) (n=20). In the first assessment (M0), the cervical flexion and extension range of motion will be measured with a goniometer. The myofascial release technique (foam roller) will be applied on the hamstrings (IG 1) or quadriceps (IG 2) of the dominant lower limb for 4 minutes (3 series of 1 minute with 30s rest). Participants in the control group will remain at rest sitting in a chair for 4 minutes.
Immediately after the intervention/control, both groups will be assessed, again (M1).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1 | Active comparator | Other: Dynamic foam rollingA myofascial release technique will be performed using a foam roller (Blackroll Standard, 30 x 15 cm) on the dominant lower limb. For the IG 1, the technique will be applied to the hamstrings muscles. In this group, participants will sit on the floor on a mat with the roller under their thighs. Their hands will be placed on the floor with their fingers pointing downwards. The foam roller will be in contact with the muscle being tested and the patient will exert a load until they feel a slight pain. In this way, the patient performs a self-massage in the direction of the muscle fibers. The limb that will not be tested will function as a lever, it will remain bent to the side, which will allow the simple realization of the glide. A cycle of the procedure will be defined as a proximal to distal rolling movement, so the frequency in this study will be 25 cycles per minute measured with a metronome from a mobile application (Smart Metronome \& Tuner v.11.8 IOS). |
| Intervention group 2 | Active comparator | Other: Dynamic foam rollingA myofascial release technique will be performed using a foam roller (Blackroll Standard, 30 x 15 cm) on the dominant lower limb. The IG 2 will perform the same technique on a different muscle group: the quadriceps. In this way, the positioning will be different, the participants will be in the prone position, in a plank position, leaning on the forearms, the body well aligned and the studied lower limb well stretched. However, the participant will also perform a self-massage in the direction of the muscle fibers until they feel slight pain. The duration of the procedure will be set at 4 minutes in this study; 3 rounds of 1 minute (30 s rest). A cycle of the procedure will be defined as a proximal to distal rolling movement, so the frequency in this study will be 25 cycles per minute measured with a metronome from a mobile application (Smart Metronome \& Tuner v.11.8 IOS). |
| Control group | No intervention | –The participants will remain at rest in a chair for 4 minutes. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy university students of both genders with normal mobility of the joints.
Key exclusion criteria (5 listed)
- Deformities in the lower quadrant region of the body;
- Complaints in this region in the last 6 months;
- Surgical procedures or musculoskeletal, cardiac, renal, metabolic, neurological and or oncological pathologies
- Pregnant women
- Ingestion of non-steroidal anti-inflammatory drugs or consumption of any type of narcotic drugs and participants who have drunk alcohol in the last 12 hours.
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 |
|---|---|---|
| Dynamic foam rollingThe foam roller will be in contact with the muscle being tested and the patient will exert a load until they feel a slight pain. In this way, the patient performs a self-massage in the direction of the muscle fibers. | Other | Intervention group 1, Intervention group 2 |
Primary outcome
Change of active cervical range of motion in flexion and extension.
Time frame: Change from Baseline (M0) to Immediately after intervention or control (M1)
Data will be collected in two moments: baseline (M0) and after the intervention/control (M1). Participants will be asked to sit with their spine straight against the back of the chair. The ankles, knees and hips of the subjects will be positioned at right angles and the arms crossed over the chest to minimize thoracic movements. The position of the goniometer (GIMA, 37.5 x 6.5 x 0.5 cm) will be as follows: the fixed point at the level of the external acoustic meatus, and the mobile arm at the level of the base of the nose (initial position: 90°). The fixed arm will be immobile, parallel to the ear and perpendicular to the ground. Prior to the test, each participant will have performed both movements until the final sensation is reached in order to increase the fluidity of the test. Thus, the first movement asked of the patient will be a flexion followed by an extension (the examiner will take the average of three measurements).
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 18 May 2023.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic foam rolling in people with Healthy, run by University Fernando Pessoa at 2 sites in Portugal.
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 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 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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?
Change of active cervical range of motion in flexion and extension. (time frame: Change from Baseline (M0) to Immediately after intervention or control (M1)). 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 18 May 2023.