The Effects of Proprioceptive Neuromuscular Facilitation Training

November 25, 2019 updated by: Caner Karartı, Hacettepe University

The Effects of Proprioceptive Neuromuscular Facilitation Training on Pain, Range of Motion, Functional Disability Index, Back Extensor Muscle Endurance, and Diaphragm Muscle Thickness in Patients With Chronic Low Back Pain

Although various methods have been emphasized in the treatment of chronic low back pain (CLBP), one of the treatments with the highest level of evidence is tailor-made exercises. Exercises to improve lumbopelvic region muscle performance and proprioception have been reported to be effective in alleviating clinical symptoms in individuals with CLBP. Proprioceptive neuromuscular facilitation (PNF) techniques are frequently used in the treatment of CLBP. PNF techniques reduce the load on vertebral bodies when performed in supine, side-lying, and sitting positions. It has been reported that performing a PNF trunk pattern in a sitting position is effective for treating CLBP and it improves muscle endurance, flexibility, and functional performance. PNF lower extremity pattern training in a supine position is effective for abdominal muscle activation. There is also an improvement in pain, functional disability, and fear-avoidance belief by applying the PNF coordination pattern in a standing position. While the diaphragm effect was emphasized in individuals with CLBP, no studies examining the effect of PNF techniques used on CLBP treatment on diaphragm muscle thickness were found. In addition, studies investigating the effect of PNF techniques on pain, functional disability index, range of motion and waist muscle endurance were found to be insufficient. Therefore, the aim of this study was to investigate the effect of PNF techniques on related variables in individuals with CLBP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

It is known that dorsal proprioceptive signals, one of the necessary components in providing lumbopelvic motor control, are decreased in individuals with chronic low back pain (CLBP) and respiratory dysfunction. Diaphragm, which is an important postural control muscle, plays an important role in the correct reception of these signals. Electromyographic and ultrasonographic measurements in healthy subjects showed that the diaphragm was activated for anticipatory automatic adjustments before shoulder flexion, adjusted the transdiaphragmatic pressure and shortened the neck before motion began. In CLBP, diaphragm motility decreases significantly due to fatigue in the diaphragm. This makes it difficult to perform anticipatory automatic arrangements, leading to postural instability and respiratory dysfunction. Although various methods have been emphasized in the treatment of CLBP, one of the treatments with the highest level of evidence is tailor-made exercises. Exercises to improve lumbopelvic region muscle performance and proprioception have been reported to be effective in alleviating clinical symptoms in individuals with CLBP. Proprioceptive neuromuscular facilitation (PNF) techniques are frequently used in the treatment of CLBP. PNF techniques reduce the load on vertebral bodies when performed in supine, side-lying, and sitting positions. It has been reported that performing a PNF trunk pattern in a sitting position is effective for treating CLBP and it improves muscle endurance, flexibility, and functional performance. PNF lower extremity pattern training in a supine position is effective for abdominal muscle activation. There is also an improvement in pain, functional disability, and fear-avoidance belief by applying the PNF coordination pattern in a standing position. While the diaphragm effect was emphasized in individuals with CLBP, no studies examining the effect of PNF techniques used on CLBP treatment on diaphragm muscle thickness were found. In addition, studies investigating the effect of PNF techniques on pain, functional disability index, range of motion and waist muscle endurance were found to be insufficient. Therefore, the aim of this study was to investigate the effect of PNF techniques on related variables in individuals with CLBP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presence of non-spesific CLBP (˃3 months),
  • the ability to understand and follow verbal commands,
  • to be volunteer to participate in the study.

Exclusion Criteria:

  • to be pregnant,
  • had a previous history of spinal surgery,
  • neurological deficits,
  • specific LBP (including facet joint syndrome, disc herniation and sacroiliac joint dysfunction),
  • cancer or other autoimmune diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Experimental-Study Group
In addition to the conservative treatment of the control group, proprioceptive neuromuscular facilitation techniques will be applied for 4 weeks.
Other: Proprioceptive Neuromuscular Facilitation Training
The Proprioceptive Neuromuscular Facilitation Training will be performed using patterns and techniques in various positions for abdominal and back muscles' facilitation and strengthening. Supine, side-lying, and sitting positions will be used. There will be a rest of about 20 sec between sets. Warm-up for 10 min, main exercises for 25 min, cool-down for 10 min (a total of 45 min), 5 times a week for 4 weeks.
ACTIVE_COMPARATOR: Control Group
Conservative treatment of low back pain will be applied for 4 weeks.
Other: Control Group
Ultrasound, TENS, massage, and exercise will be used with each other because in most of the physical therapy clinics these modalities are used together for such problems as a conventional treatment. After massage application, hamstring and paravertebral muscles stretching and also stabilizing exercises will be prescribed, each one for ten times in each session.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual analog scale (VAS)
Time Frame: 4 weeks
The pain severity of the patients with CLBP will be measured using a 10 centimeter VAS where score of 0/10 indicated no pain and 10/10 to indicated intolerable pain, respectively. A clinically meaningful difference for the VAS is a reduction of approximately two points for patients with CLBP.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Oswestry Disability Index (ODI)
Time Frame: 4 weeks
This scale is intended to measure the disability level due to CLBP. It consists of ten questions: pain intensity, personal care, lifting, walking, sitting, standing, sleep¬ing, sex life, and social life. Depending on performance ability, 6 levels (0 to 5 points) can be specified: the higher the score, the greater the disability. The ODI is calculated by dividing the total score by the number of questions answered and multiplying by 100. The participants will be asked whether any statements characterized them on evaluation day. The Turkish version of ODI has good comprehensibility, internal consistency, and validity and is an adequate and useful instrument for the assessment of disability in patients with low back pain (internal consistency=0.89-0.91). The minimal detectable change on the ODI is 6-10 points. Clinically meaningful change is considered to be 30-50%.
4 weeks
The Schober Test
Time Frame: 4 weeks
The Schober Test will be used for the assessment of lumbar flexion range of motion (ROM) of the patients with CLBP. In relaxed standing position, the mid-point between the two posterior superior iliac spines will be determined. Then, 5 centimeter above and 5 centimeter below this point will be marked as measurement points. At this stage, patients will be asked to bend forwardly as much as possible while maintaining their knees as straight as possible. The difference between the two points in this position in comparison to distance between the points in relaxed standing position will be considered as the lumbar flexion ROM.
4 weeks
The Prone Doubled Leg Straight Leg Raising (SLR)
Time Frame: 4 weeks
SLR will be used for the evaluation of back extensor muscle endurance of the patients with CLBP. Participants lay in prone position with their hips extended, putting their hands underneath their foreheads. They will be asked to raise both of their legs until knee clearance will be achieved. At this stage the examiner will record the time until the participant will no longer able to keep knee clearance. The recorded time in seconds will be considered as back extensor muscle endurance.
4 weeks
Ultrasonographic Imaging
Time Frame: 4 weeks
Ultrasonographic imaging will be conducted by a radiologist (experience˃15 years) to determine muscle thickness of diaphragm. Thickness of both hemidiaphragm will be measured at the end of expiration from transvers and sagittal images obtained at the 9th intercostal space on anterior axillary line.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019700

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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