Back to resultsNeural Gliding Exercise for Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neural gliding exercises
Electrotherapy sessions
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Neurodynamics
Eligibility Criteria
Inclusion Criteria:
- Subjects scoring below 70 degrees in the straight leg raise test
- received no physiotherapy until at least 6 months before initial evaluation
Exclusion Criteria:
- 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.
Sites / Locations
- Kutahya Health Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Patient received neural gliding exercises in addition electrotehrapy sessions.
Patient received only electrotherapy sessions
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Oswestry Disability Index
The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Full Information
NCT ID
NCT03972085
First Posted
May 28, 2019
Last Updated
May 31, 2019
Sponsor
Kutahya Health Sciences University
1. Study Identification
Unique Protocol Identification Number
NCT03972085
Brief Title
Neural Gliding Exercise for Low Back Pain
Official Title
Comparison of Conservative Treatment With and Without Neural Gliding Exercise for Patients With Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
November 7, 2015 (Actual)
Study Completion Date
November 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
There are many physiotherapy modalities in the treatment of low back pain (LBP). Electrotherapy procedures, manual therapy techniques, kinesiotherapy and specific exercises are among those that are frequently used. In neural mobilization techniques, which began to gain popularity in 1990s, neural tissue and the surrounding structures are glided or tensioned to mobilize them. Neural mobilization is thought to have a positive effect on symptoms by inducing intraneural circulation, axoplasmic flow, and neural visco-elasticity and sensitivity associated with the connective tissue. There are studies in which this modality has yielded therapeutic success in terms of both pain and functionality, particularly in lumbar region and lower limb disorders where neural mechanosensitivity is increased.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low Back Pain, Neurodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Patient received neural gliding exercises in addition electrotehrapy sessions.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Patient received only electrotherapy sessions
Intervention Type
Other
Intervention Name(s)
Neural gliding exercises
Other Intervention Name(s)
Electrotherapy sessions
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Electrotherapy sessions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) for pain levels
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Oswestry Disability Index
Description
The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects scoring below 70 degrees in the straight leg raise test
received no physiotherapy until at least 6 months before initial evaluation
Exclusion Criteria:
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.
Facility Information:
Facility Name
Kutahya Health Science University
City
Kutahya
State/Province
Center
ZIP/Postal Code
43000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Neural Gliding Exercise for Low Back Pain
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