NCT04178356

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable low-back-pain

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

December 20, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

November 25, 2019

Last Update Submit

November 25, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (4)

  • The Oswestry Disability Index (ODI)

    4 weeks

  • The Schober Test

    4 weeks

  • The Prone Doubled Leg Straight Leg Raising (SLR)

    4 weeks

  • Ultrasonographic Imaging

    4 weeks

Study Arms (2)

Experimental-Study Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

Conservative treatment of low back pain will be applied for 4 weeks.

Other: Control Group

Interventions

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.

Experimental-Study 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.

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

  • Areeudomwong 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.

  • Kofotolis 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.

MeSH Terms

Conditions

Low Back Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Caner KARARTI, PT, MSc.

CONTACT

Çağdaş BASAT, Assoc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Single blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Caner Karartı, Hacettepe University

Study Record Dates

First Submitted

November 25, 2019

First Posted

November 26, 2019

Study Start

December 20, 2019

Primary Completion

March 20, 2020

Study Completion

April 20, 2020

Last Updated

November 26, 2019

Record last verified: 2019-11