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

NCT05926674 | Completed

• 1 other identifier: BHS-1851
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

N/A Healthy Individuals

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

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.

Other: Light Touch Contact

Interventions

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.

Myofascial Release

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.

Light Touch Contact

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York Institute of Technology: lead

Study Sites (1)

NYIT

Old Westbury, New York, 11568, United States

Location

MeSH Terms

Interventions

Myofascial Release Therapy

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Mark Gugliotti, DPT

  New York Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will not have knowledge of each participant's intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: This study is a double-arm repeated measures study performed in a single session lasting approximately 30-40 minutes.

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: July 3, 2023
• Study Start: July 15, 2023
• Primary Completion: July 22, 2023
• Study Completion: July 26, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)