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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:
Researchers will compare an experimental group and a control group to examine the effects.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myofascial Release | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 1 minute |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Gugliotti, DPT | New York Institute of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYIT | Old Westbury | New York | 11568 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40325735 | Derived | 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. |
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There is no plan to share IPD for this study.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 27, 2025 | |
| Reset | Feb 18, 2025 | |
| Release | Jun 28, 2025 | |
| Reset | Jul 16, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 27, 2025 | Feb 18, 2025 | |||
| Jun 28, 2025 |
| ID | Term |
|---|---|
| D000089803 | Myofascial Release Therapy |
| ID | Term |
|---|---|
| D008405 | Massage |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
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This study is a double-arm repeated measures study performed in a single session lasting approximately 30-40 minutes.
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Outcomes assessors will not have knowledge of each participant's intervention.
|
| Light Touch Contact | Other | 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. |
|
| Jul 16, 2025 |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |