NCT03972085

Brief Summary

Low back pain is a very common problem that causes pain, disability, gait and balance problems. Neurodynamic techniques is used for treatment of low back pain. The aim of the study is comparing the effects of electrotherapy and neural mobilization techniques on pain, functionality, gait and balance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

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

February 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2015

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2015

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
Last Updated

June 3, 2019

Status Verified

May 1, 2019

Enrollment Period

9 months

First QC Date

May 28, 2019

Last Update Submit

May 31, 2019

Conditions

Keywords

Low Back PainNeurodynamics

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS) for pain levels

    The VAS was used to assess the participants' pain levels. In the VAS, patients are asked to mark the severity of their pain on a scale from 0 to 10. The VAS ranges from '0' representing no pain and '10' representing the worst pain.

    3 weeks

Secondary Outcomes (1)

  • Oswestry Disability Index

    3 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Patient received neural gliding exercises in addition electrotehrapy sessions.

Other: Neural gliding exercisesOther: Electrotherapy sessions

Group 2

ACTIVE COMPARATOR

Patient received only electrotherapy sessions

Other: Electrotherapy sessions

Interventions

Neural gliding exercises: In addition to the Electrotherapy procedure, patients were asked to actively perform knee extension, ankle dorsiflexion and head extension in the slumped posture followed by simultaneous ankle plantar flexion together with knee and head flexion (10 repetitions in 1 minute). Patients performed the exercises under a home-based program for 5 days of the week during a total period of 3 weeks. Electrotherapy sessions: Local Hot Pack (30 minutes), Chattanoga™ TENS (20 minutes, 80-180 Hz frequency, 50-100 wavelength) and Chattanoga™ ultrasound (1 Mhz frequency, 3 W/cm2 3 minutes) were applied for 5 days per week during a total period of 3 weeks. Subjects in ETG did not do any other exercise approach.

Also known as: Electrotherapy sessions
Group 1

Electrotherapy sessions: Local Hot Pack (30 minutes), Chattanoga™ TENS (20 minutes, 80-180 Hz frequency, 50-100 wavelength) and Chattanoga™ ultrasound (1 Mhz frequency, 3 W/cm2 3 minutes) were applied for 5 days per week during a total period of 3 weeks. Subjects in ETG did not do any other exercise approach.

Group 1Group 2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects scoring below 70 degrees in the straight leg raise test
  • received no physiotherapy until at least 6 months before initial evaluation

You may not qualify if:

  • subjects who were unable to walk independently,
  • who had systemic diseases besides LBP,
  • who underwent spinal and lower limb surgery,
  • who scored above 70 degrees in the straight leg raise test,
  • used analgesics within 48 hours before initial evaluation were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Science University

Kütahya, Center, 43000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 28, 2019

First Posted

June 3, 2019

Study Start

February 1, 2015

Primary Completion

November 7, 2015

Study Completion

November 30, 2015

Last Updated

June 3, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations