N/A Healthy IndividualsNCT05926674
Does Manual Therapy Provide Immediate Improvement in Lumbar Range of Motion?
A study testing Myofascial Release and Light Touch Contact in people with N/A Healthy Individuals, run by New York Institute of Technology at 1 site in United States.
Trial summary
The goal of this clinical study is to determine if manual therapy can improve lumbar mobility in healthy individuals. The main questions it aims to answer are: Is there an immediate local spinal effect? Is there an associated distal effect? Researchers will compare an experimental group and a control group to examine… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- N/A Healthy Individuals
- What is being tested?
- Myofascial Release and Light Touch Contact
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2023to 26 Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- New York Institute of Technology students
- At least 18 years old
- Good overall health
Who cannot join
- Pacemaker
- Any previous history of lumbar or connective tissue pathology
- Down syndrome
- Prolonged steroid use
- Oswestry Low Back Disability score of >10 (ODI)
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effects of Myofascial Release on Lumbar Range of Motion. A Randomized Control Trial.
The goal of this clinical study is to determine if manual therapy can improve lumbar mobility in healthy individuals.
The main questions it aims to answer are:
- Is there an immediate local spinal effect?
- Is there an associated distal effect?
Researchers will compare an experimental group and a control group to examine the effects.
Read the detailed description
Upon consent, participants will be assessed for lumbar spine mobility using inclinometers, hamstring flexibility using the active knee extension test and the modified sit-and-reach test, and ease of lifting a small, weighted object. After baseline measures are recorded, the participants will receive an intervention that will be either therapeutic (myofascial release) or sham (non-therapeutic hand placement). The choice of intervention received will be previously determined through the use of randomization software. The intervention provided will be applied to the low back and last for a total of 10 minutes. Immediately following the intervention, participants will again be assessed for lumbar spine mobility, hamstring flexibility, and ease of lifting a small, weighted object as noted above.
- Conditions
- N/A Healthy Individuals
- Being tested
- Myofascial Release, Light Touch Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial ReleaseOther
Myofascial release is a manual therapy technique commonly used by clinicians and bodyworkers to provide effects such as decreased pain, improvement in flexibility, ROM, and quality of life. It combines non-gliding fascial traction with varying amounts of stretching to produce a tensional force on the muscle and its associated fascia resulting in viscoelastic lengthening and deformation.
Light Touch ContactOther
The sham treatment of light touch will be applied to the lumbar spine and this form of contact is not therapeutic. It is only meant to only mimic a manual therapy technique.
| Study group | Role | What they receive |
|---|---|---|
| Myofascial Release | Experimental | Myofascial release (MFR) is a manual therapy technique commonly used by clinicians and bodyworkers to provide effects such as decreased pain, improvement in flexibility, ROM, and quality of life. It combines non-gliding fascial traction with varying amounts of stretching to produce a tensional force on the muscle and its associated fascia resulting in viscoelastic lengthening and deformation.
Myofascial release will be provided to each subject assigned to the experimental group by the primary investigator (PI). The participant will be positioned in prone and the MFR will be applied along the lumbar paraspinals bilaterally for five minutes per side. Receives: Other: Myofascial Release |
| Light Touch Contact | Sham comparator | Sham treatment will be provided to each subject assigned to the control group by the designated co-investigator. The sham treatment of light touch will be applied to the lumbar paraspinals in the same fashion as noted above. This form of light touch contact is not therapeutic and is meant to only mimic a manual therapy technique. Receives: Other: Light Touch Contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar Range of Motion
Upon arrival, the participant will be greeted and directed to the research room. The participant will be instructed to stand comfortably with their feet shoulder width apart, followed by one inclinometer placed at the level of S2 and the other 15cm above S2 by the designated researcher. The placement of the inclinometers is necessary to establish proper measurement of the lumbar spine, independent of outside influence. Inclinometers are valid and reliable tools for measuring lumbar ROM. Lumbar flexion will be measured first, followed by lateral flexion to the left and right. Lumbar ROM will be measured before and after each treatment.
Measured: 3 minutes
Modified Sit and Reach test
The modified sit and reach test is a valid and reliable tool for assessing hamstring flexibility. This assessment will be implemented by the designated researcher. The modified sit and reach test will be administered before and after each treatment.
Measured: 3 minutes
Active Knee Extension test
The test is performed supine with the tested leg bent to 90° of supported hip flexion. The participant will be asked to actively extend his or her knee as fully as possible. Any lag from full extension will be measured with a standard goniometer. This test is a valid and reliable tool for hamstring length assessment. An extension lag of greater than 20° indicates a lack of hamstring flexibility. This will be performed on both lower extremities before and after each treatment.
Measured: 3 minutes
Functional Movement Assessment
Each participant will be asked to perform a low-level functional activity (picking up a light-weight object) to help identify any perceived change in ability following the intervention.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start15 Jul 2023
- Primary completion22 Jul 2023
- Study completion26 Jul 2023
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 N/A Healthy IndividualsStudies 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
- This study is a double-arm repeated measures study performed in a single session lasting approximately 30-40 minutes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Gugliotti, New York Institute of Technology
- Investigators
- Mark Gugliotti, DPT, Principal investigator, New York Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926674
- Sponsor's protocol ID
- BHS-1851
- Status last verified
- Nov 2023
- First submitted
- 7 Jun 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD for this study.
Publications
Gugliotti M, Rothstein A, Badash E, Cruz R, Cummings C, Karafa B, Santiago T. The immediate effects of myofascial release on lumbar range of motion and flexibility in healthy individuals: A double-blind, randomized sham-controlled trial. J Bodyw Mov Ther. 2025 Jun;42:645-650. doi: 10.1016/j.jbmt.2025.01.052. Epub 2025 Jan 30.
PubMed 40325735
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Myofascial Release on Lumbar Range of Motion. A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT05926674
- Acronym / sponsor ID
- BHS-1851
- Conditions
- N/A Healthy Individuals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 22 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 3 Jul 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 goal of this clinical study is to determine if manual therapy can improve lumbar mobility in healthy individuals.
The main questions it aims to answer are:
- Is there an immediate local spinal effect?
- Is there an associated distal effect?
Researchers will compare an experimental group and a control group to examine the effects.
Detailed description
Upon consent, participants will be assessed for lumbar spine mobility using inclinometers, hamstring flexibility using the active knee extension test and the modified sit-and-reach test, and ease of lifting a small, weighted object. After baseline measures are recorded, the participants will receive an intervention that will be either therapeutic (myofascial release) or sham (non-therapeutic hand placement). The choice of intervention received will be previously determined through the use of randomization software. The intervention provided will be applied to the low back and last for a total of 10 minutes. Immediately following the intervention, participants will again be assessed for lumbar spine mobility, hamstring flexibility, and ease of lifting a small, weighted object as noted above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a double-arm repeated measures study performed in a single session lasting approximately 30-40 minutes.
| Arm | Type | Receives |
|---|---|---|
| Myofascial Release | Experimental | Other: Myofascial ReleaseMyofascial release (MFR) is a manual therapy technique commonly used by clinicians and bodyworkers to provide effects such as decreased pain, improvement in flexibility, ROM, and quality of life. It combines non-gliding fascial traction with varying amounts of stretching to produce a tensional force on the muscle and its associated fascia resulting in viscoelastic lengthening and deformation. Myofascial release will be provided to each subject assigned to the experimental group by the primary investigator (PI). The participant will be positioned in prone and the MFR will be applied along the lumbar paraspinals bilaterally for five minutes per side. |
| Light Touch Contact | Sham comparator | Other: Light Touch ContactSham treatment will be provided to each subject assigned to the control group by the designated co-investigator. The sham treatment of light touch will be applied to the lumbar paraspinals in the same fashion as noted above. This form of light touch contact is not therapeutic and is meant to only mimic a manual therapy technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- New York Institute of Technology students
- At least 18 years old
- Good overall health
Key exclusion criteria (6 listed)
- Pacemaker
- Any previous history of lumbar or connective tissue pathology
- Down syndrome
- Prolonged steroid use
- Oswestry Low Back Disability score of >10 (ODI)
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 |
|---|---|---|
| Myofascial ReleaseMyofascial release is a manual therapy technique commonly used by clinicians and bodyworkers to provide effects such as decreased pain, improvement in flexibility, ROM, and quality of life. It combines non-gliding fascial traction with varying amounts of stretching to produce a tensional force on the muscle and its associated fascia resulting in viscoelastic lengthening and deformation. | Other | Myofascial Release |
| Light Touch ContactThe sham treatment of light touch will be applied to the lumbar spine and this form of contact is not therapeutic. It is only meant to only mimic a manual therapy technique. | Other | Light Touch Contact |
Primary outcome
Lumbar Range of Motion
Time frame: 3 minutes
Upon arrival, the participant will be greeted and directed to the research room. The participant will be instructed to stand comfortably with their feet shoulder width apart, followed by one inclinometer placed at the level of S2 and the other 15cm above S2 by the designated researcher. The placement of the inclinometers is necessary to establish proper measurement of the lumbar spine, independent of outside influence. Inclinometers are valid and reliable tools for measuring lumbar ROM. Lumbar flexion will be measured first, followed by lateral flexion to the left and right. Lumbar ROM will be measured before and after each treatment.
Modified Sit and Reach test
Time frame: 3 minutes
The modified sit and reach test is a valid and reliable tool for assessing hamstring flexibility. This assessment will be implemented by the designated researcher. The modified sit and reach test will be administered before and after each treatment.
Active Knee Extension test
Time frame: 3 minutes
The test is performed supine with the tested leg bent to 90° of supported hip flexion. The participant will be asked to actively extend his or her knee as fully as possible. Any lag from full extension will be measured with a standard goniometer. This test is a valid and reliable tool for hamstring length assessment. An extension lag of greater than 20° indicates a lack of hamstring flexibility. This will be performed on both lower extremities before and after each treatment.
Functional Movement Assessment
Time frame: 1 minute
Each participant will be asked to perform a low-level functional activity (picking up a light-weight object) to help identify any perceived change in ability following the intervention.
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 21 Nov 2023.
- Derived from this study: PubMed 40325735Gugliotti M, Rothstein A, Badash E, Cruz R, Cummings C, Karafa B, Santiago T. The immediate effects of myofascial release on lumbar range of motion and flexibility in healthy individuals: A double-blind, randomized sham-controlled trial. J Bodyw Mov Ther. 2025 Jun;42:645-650. doi: 10.1016/j.jbmt.2025.01.052. Epub 2025 Jan 30.
- Individual participant dataSharing planned: No. There is no plan to share IPD for this study.
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.
Mark Gugliotti, DPT principal investigator
New York Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial Release and Light Touch Contact in people with N/A Healthy Individuals, run by New York Institute of Technology 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 3 inclusion and 6 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 21 Nov 2023. 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. Some participants in this study may receive a placebo. 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?
Lumbar Range of Motion (time frame: 3 minutes). The study lists 4 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 NCT05926674, 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 21 Nov 2023.