Low Back PainNCT04178356
The Effects of Proprioceptive Neuromuscular Facilitation Training
A study testing Proprioceptive Neuromuscular Facilitation Training in people with Low Back Pain and Disability Physical, run by Hacettepe University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Disability Physical
- What is being tested?
- Proprioceptive Neuromuscular Facilitation Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2019to 20 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of non-spesific CLBP (˃3 months),
- the ability to understand and follow verbal commands,
- to be volunteer to participate in the study.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain, Disability Physical
- Being tested
- Proprioceptive Neuromuscular Facilitation Training, Control Group
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive Neuromuscular Facilitation TrainingOther
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.
Control GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental-Study Group | Experimental | In addition to the conservative treatment of the control group, proprioceptive neuromuscular facilitation techniques will be applied for 4 weeks. Receives: Other: Proprioceptive Neuromuscular Facilitation Training |
| Control Group | Active comparator | Conservative treatment of low back pain will be applied for 4 weeks. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
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.
Measured: 4 weeks
Secondary outcomes (4)
The Oswestry Disability Index (ODI)
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%.
Measured: 4 weeks
The Schober Test
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.
Measured: 4 weeks
The Prone Doubled Leg Straight Leg Raising (SLR)
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.
Measured: 4 weeks
Ultrasonographic Imaging
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start20 Dec 2019 (estimated)
- Primary completion20 Mar 2020 (estimated)
- Study completion20 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caner Karartı, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178356
- Sponsor's protocol ID
- 2019700
- Status last verified
- Nov 2019
- First submitted
- 25 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beeckmans N, Vermeersch A, Lysens R, Van Wambeke P, Goossens N, Thys T, Brumagne S, Janssens L. The presence of respiratory disorders in individuals with low back pain: A systematic review. Man Ther. 2016 Dec;26:77-86. doi: 10.1016/j.math.2016.07.011. Epub 2016 Jul 25.
PubMed 27501326Areeudomwong P, Wongrat W, Neammesri N, Thongsakul T. A randomized controlled trial on the long-term effects of proprioceptive neuromuscular facilitation training, on pain-related outcomes and back muscle activity, in patients with chronic low back pain. Musculoskeletal Care. 2017 Sep;15(3):218-229. doi: 10.1002/msc.1165. Epub 2016 Oct 28.
PubMed 27791345Kofotolis N, Kellis E. Effects of two 4-week proprioceptive neuromuscular facilitation programs on muscle endurance, flexibility, and functional performance in women with chronic low back pain. Phys Ther. 2006 Jul;86(7):1001-12.
PubMed 16813479
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04178356
- Acronym / sponsor ID
- 2019700
- Conditions
- Low Back Pain, Disability Physical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Dec 2019 (estimated)
- Primary completion
- 20 Mar 2020 (estimated)
- Study completion
- 20 Apr 2020 (estimated)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Experimental-Study Group | Experimental | Other: Proprioceptive Neuromuscular Facilitation TrainingIn addition to the conservative treatment of the control group, proprioceptive neuromuscular facilitation techniques will be applied for 4 weeks. |
| Control Group | Active comparator | Other: Control GroupConservative treatment of low back pain will be applied for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- presence of non-spesific CLBP (˃3 months),
- the ability to understand and follow verbal commands,
- to be volunteer to participate in the study.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioceptive Neuromuscular Facilitation TrainingThe 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. | Other | Experimental-Study Group |
| Control GroupUltrasound, 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. | Other | Control Group |
Primary outcome
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 secondary outcomes
The Oswestry Disability Index (ODI)
Time frame: 4 weeks
The Schober Test
Time frame: 4 weeks
The Prone Doubled Leg Straight Leg Raising (SLR)
Time frame: 4 weeks
Ultrasonographic Imaging
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Results publication: PubMed 27501326Beeckmans N, Vermeersch A, Lysens R, Van Wambeke P, Goossens N, Thys T, Brumagne S, Janssens L. The presence of respiratory disorders in individuals with low back pain: A systematic review. Man Ther. 2016 Dec;26:77-86. doi: 10.1016/j.math.2016.07.011. Epub 2016 Jul 25.
- Results publication: PubMed 27791345Areeudomwong P, Wongrat W, Neammesri N, Thongsakul T. A randomized controlled trial on the long-term effects of proprioceptive neuromuscular facilitation training, on pain-related outcomes and back muscle activity, in patients with chronic low back pain. Musculoskeletal Care. 2017 Sep;15(3):218-229. doi: 10.1002/msc.1165. Epub 2016 Oct 28.
- Results publication: PubMed 16813479Kofotolis N, Kellis E. Effects of two 4-week proprioceptive neuromuscular facilitation programs on muscle endurance, flexibility, and functional performance in women with chronic low back pain. Phys Ther. 2006 Jul;86(7):1001-12.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Neuromuscular Facilitation Training in people with Low Back Pain and Disability Physical, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caner KARARTI, PT, MSc. (03862805362, fzt.caner.92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04178356, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.