- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03972085
Neural Gliding Exercise for Low Back Pain
Comparison of Conservative Treatment With and Without Neural Gliding Exercise for Patients With Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Center
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Kutahya, Center, Turkey, 43000
- Kutahya Health Science University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Group 1
Patient received neural gliding exercises in addition electrotehrapy sessions.
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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.
Other Names:
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.
|
|
ACTIVE_COMPARATOR: Group 2
Patient received only electrotherapy sessions
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS) for pain levels
Time Frame: 3 weeks
|
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.
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3 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oswestry Disability Index
Time Frame: 3 weeks
|
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.
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3 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 80558721/153-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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