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

Sponsor
New York Institute of Technology (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05926674
Collaborator
(none)
40
2
10

Study Details

Study Description

Brief 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 the effects.

Condition or Disease Intervention/Treatment Phase
  • Other: Myofascial Release
  • Other: Light Touch Contact
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is a double-arm repeated measures study performed in a single session lasting approximately 30-40 minutes.This study is a double-arm repeated measures study performed in a single session lasting approximately 30-40 minutes.
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcomes assessors will not have knowledge of each participant's intervention.
Primary Purpose:
Treatment
Official Title:
Immediate Effects of Myofascial Release on Lumbar Range of Motion. A Randomized Control Trial.
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Myofascial Release

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.

Other: Myofascial Release
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.

Sham Comparator: Light Touch Contact

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.

Other: Light Touch Contact
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.

Outcome Measures

Primary Outcome Measures

  1. Lumbar Range of Motion [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • New York Institute of Technology

Investigators

  • Principal Investigator: Mark Gugliotti, DPT, New York Institute of Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mark Gugliotti, Doctor, New York Institute of Technology
ClinicalTrials.gov Identifier:
NCT05926674
Other Study ID Numbers:
  • BHS-1851
First Posted:
Jul 3, 2023
Last Update Posted:
Jul 3, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 3, 2023