Low Back PainNCT03972085
Neural Gliding Exercise for Low Back Pain
A study testing Neural gliding exercises and Electrotherapy sessions in people with Low Back Pain, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Neural gliding exercises and Electrotherapy sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2015to 30 Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects scoring below 70 degrees in the straight leg raise test
- received no physiotherapy until at least 6 months before initial evaluation
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Science University
Kütahya, Center, 43000
About this study
Official title: Comparison of Conservative Treatment With and Without Neural Gliding Exercise for Patients With Low Back Pain
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Neural gliding exercises, Electrotherapy sessions
- Keywords
- Low Back Pain, Neurodynamics
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural gliding exercisesOther
Also called Electrotherapy sessions
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.
Electrotherapy sessionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patient received neural gliding exercises in addition electrotehrapy sessions. Receives: Other: Neural gliding exercises; Other: Electrotherapy sessions |
| Group 2 | Active comparator | Patient received only electrotherapy sessions Receives: Other: Electrotherapy sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (1)
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Feb 2015
- Primary completion7 Nov 2015
- Study completion30 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vedat KURT, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972085
- Sponsor's protocol ID
- 80558721/153-002
- Status last verified
- May 2019
- First submitted
- 28 May 2019
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conservative Treatment With and Without Neural Gliding Exercise for Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT03972085
- Acronym / sponsor ID
- 80558721/153-002
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Neurodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 7 Nov 2015 (actual)
- Study completion
- 30 Nov 2015 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Neural gliding exercises, Other: Electrotherapy sessionsPatient received neural gliding exercises in addition electrotehrapy sessions. |
| Group 2 | Active comparator | Other: Electrotherapy sessionsPatient received only electrotherapy sessions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects scoring below 70 degrees in the straight leg raise test
- received no physiotherapy until at least 6 months before initial evaluation
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neural gliding exercisesAlso: Electrotherapy sessionsNeural 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 | Group 1 |
| Electrotherapy sessionsElectrotherapy 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 | Group 1, Group 2 |
Primary outcome
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.
1 secondary outcome
Oswestry Disability Index
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural gliding exercises and Electrotherapy sessions in people with Low Back Pain, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) for pain levels (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019; AzTrials last refreshed its copy on 31 Oct 2026.