NCT03651440

Brief Summary

Background/Objective: This study investigates the effect of lumbar stabilization and proprioceptive neuromuscular facilitation (PNF) training on muscle strength and muscle endurance. Methods: Sixty-four participants between the ages of 15 and 69 years, graded "protrusion and bulging lumbar herniation" according to the Macnab Classification, were divided into four groups of 16: lumbar stabilization training (strength training, 5 days/week for 4 weeks); PNF training (5 days/week for 4 weeks); physical therapy (hot pack, TENS, ultrasound, 5 days/week for 4 weeks); and control (without any application). Sociodemographic features were recorded and muscle strength tested. Before and after exercise, a visual analog scale (VAS) and Oswestry Disability Index (ODI) were measured by a physical therapist. After 4 weeks, the evaluations were repeated. Results: There were significant increases in muscle strength and muscle endurance in the lumbar stabilization group, who also showed significant improvement in pain intensity at rest and during activity, and in ODI (p\<0.05). Similar results were observed in the PNF group (p\<0.05), although not to the same extent. Patients undergoing physical therapy showed significant differences only in pain intensity at rest, at activity, and in ODI (p\<0.05). Conclusion: Undertaking an appropriate physiotherapy and rehabilitation program aiming to reduce waist circumference of patients with low muscle strength and low muscle endurance will help to increase muscle strength and endurance and reduce pain, and contribute toward the correction of functional disabilities.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Status
completed

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

Study Start

First participant enrolled

May 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

8 months

First QC Date

August 8, 2018

Last Update Submit

August 28, 2018

Conditions

Keywords

Disc herniationEnduranceLumbar stabilization exercisePNFStrength

Outcome Measures

Primary Outcomes (1)

  • visual analog scale

    . A standard visual analog scale (VAS) was a used to assess pain. The patients graded their low back pain on a 10-point scale, anchored with the descriptors "no pain" at one end and "pain as bad as it could possibly be" at the other. Maximum pain severity was assessed by a blind-testing physician using the standard VAS

    4 weeks

Secondary Outcomes (1)

  • Oswestry Disability Index

    4 weeks

Study Arms (4)

lumbar stabilization training

EXPERIMENTAL

lumbar stabilization training exercises

Other: lumbar stabilization training

PNF training

EXPERIMENTAL

PNF training exercises

Other: PNF

physical therapy

EXPERIMENTAL

HP,TENS US

Other: Physical Therapy

control

SHAM COMPARATOR

NO APPLİCATİON

Other: Control

Interventions

PNFOTHER

PNF

PNF training

lumbar stabilization training

lumbar stabilization training

Physical Therapy

physical therapy
ControlOTHER

Control group

control

Eligibility Criteria

Age15 Years - 69 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who were graded as "protrusion and bulging lumbar herniation" according to the Macnab Classification.

You may not qualify if:

  • Subjects with acute radicular signs or symptoms and those who had radiographic evidence of inflammatory disease affecting the spine, tumor, fracture, spondylolysis, spondylolisthesis, or scoliosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • mitat koz, Prof.Dr.

    Ankara University

    STUDY DIRECTOR
  • nilay comuk balcı, Assoc. Prof

    Baskent University

    PRINCIPAL INVESTIGATOR
  • nuri çetin, MD.Prof.Dr.

    Baskent University

    PRINCIPAL INVESTIGATOR
  • atakan yılmaz, Pt

    Baskent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

August 8, 2018

First Posted

August 29, 2018

Study Start

May 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

August 29, 2018

Record last verified: 2018-08