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OpenTrials
Completed

NCT Number: NCT05926674

Does Manual Therapy Provide Immediate Improvement in Lumbar Range of Motion?

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.

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Key information

Conditions

N/A Healthy Individuals

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYIT

Old Westbury, New York, 11568, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • New York Institute of Technology students
  • At least 18 years old
  • Good overall health

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

New York Institute of Technology

Other

Registry information

Official study title

Immediate Effects of Myofascial Release on Lumbar Range of Motion. A Randomized Control Trial.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 3, 2023
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.