RadiculopathyNCT03621878
Effect of Neural Mobilization on Lumbosacral Radiculopathy Patients With Peripheral Sensitization
A study testing Neural mobilization exercises -Tensioner technique, Neural mobilization exercises -Slider technique and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Radiculopathy, run by Mohammed Al-Ghamdi.
Trial summary
The primary purpose of this study was to investigate the effects of slider and tensioner techniques on pain, hip and knee ROM in lumbosacral radiculopathy patients with peripheral sensitization. A secondary purpose was to evaluate the correlation between these outcomes measurements. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Radiculopathy
- What is being tested?
- Neural mobilization exercises -Tensioner technique, Neural mobilization exercises -Slider technique and Transcutaneous Electrical Nerve Stimulation (TENS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 30 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with lumbosacral radiculopathy with dominant peripheral sensitization
- patients with unilateral leg pain.
- patient S-LANSS score > 12,
- negative sensory and motor examination.
- positive neural tissue provocation tests (straight leg raising test, slump test).
- adult.
- pain duration of more than 3 months.
Who cannot join
- S-LANSS score ≥ 12,
- motor or sensory deficits,
- history of back or lower extremity surgeries,
- bilateral referred pain,
- patients with pacemakers, cardiovascular problems, epilepsy, active malignancy, dermatological conditions, and diminished pain sensation.
About this study
Official title: Effect of Neural Mobilization Techniques on Pain, and Hip and Knee Range of Motion on Lumbosacral Radiculopathy Patients With Peripheral Sensitization
The primary purpose of this study was to investigate the effects of slider and tensioner techniques on pain, hip and knee ROM in lumbosacral radiculopathy patients with peripheral sensitization. A secondary purpose was to evaluate the correlation between these outcomes measurements.
Read the detailed description
Study design: Double-blind case-control trial. Methods: Fifty-one male lumbosacral radiculopathy patients with peripheral sensitization, were divided into one of the three groups: slider, tensioner, and control. The primary outcome measurements were visual analog scale (VAS) for pain, hip range of motion (ROM) during SLR test, and knee flexion ROM during slump test. The measurements were taken at baseline, after 1st, 3rd, and 6th session.
Statistical Analysis: A two-way mixed design analysis of variance (MANOVA) with post-hoc (Bonferonni Correction) was used to calculate the differences with Time (baseline, 1st,3rd,6th sessions) as a within-group factor and Group (control, slider, and tensioner) as a between-group factor. The effect size was calculated with Cohen's d. Pearson's correlation was used for correlation analysis.
- Conditions
- Radiculopathy
- Being tested
- Neural mobilization exercises -Tensioner technique, Neural mobilization exercises -Slider technique, Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- Lumbosacral radiculopathy, peripheral sensitization, Neural mobilization, radicular LBP, slider, tensioner
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural mobilization exercises -Tensioner techniqueOther
Exercise aiming to lengthen the neural structure using more than one joint.
Neural mobilization exercises -Slider techniqueOther
Exercise aiming to slide/glide the neural structure using more than one joint.
Transcutaneous Electrical Nerve Stimulation (TENS)Other
Also called Control
Electrotherapy device aiming to decrease patient's symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients in this group had 6 sessions in 2 weeks of Transcutaneous Electric Nerve Stimulation (TENS). Receives: Other: Transcutaneous Electrical Nerve Stimulation (TENS) |
| Tensioner Group | Experimental | Patients in this group had 6 sessions in 2 weeks of TENS combined with neural mobilization exercises (Tensioner technique). Receives: Other: Neural mobilization exercises -Tensioner technique |
| Slider Group | Experimental | Patients in this group had 6 sessions in 2 weeks of TENS combined with neural mobilization exercises (Slider technique). Receives: Other: Neural mobilization exercises -Slider technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Visual analog scale was used to measure pain intensity. This scale is a 10 cm line where patients chose from 0 to 10 (when 0 mean no pain and 10 mean maximum pain)
Measured: The measurements were taken at days "0,1,5,12"
Hip Flexion Range of Motion (Symptomatic Side)
Change in Hip flexion range of motion during straight leg raising (symptomatic side)
Measured: The measurements were taken at days "0,1,5,12"
Knee Flexion Range of Motion (Symptomatic Side)
Change in Knee flexion range of motion during slump (symptomatic side)
Measured: The measurements were taken at days "0,1,5,12"
Hip Flexion Range of Motion (Asymptomatic Side)
Change in Hip Flexion Range of Motion During Straight Leg Raising (Asymptomatic Side)
Measured: The measurements were taken at days "0,1,5,12"
Knee Flexion Range of Motion (Asymptomatic Side)
Change in Knee flexion range of motion during slump (Asymptomatic side)
Measured: The measurements were taken at days "0,1,5,12"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Jul 2015
- Primary completion28 Nov 2017
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RadiculopathyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammed Al-Ghamdi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammed Al-Ghamdi, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621878
- Sponsor's protocol ID
- IRB-2014-04-321
- Status last verified
- Feb 2023
- First submitted
- 30 Jul 2018
- Last updated
- 1 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neural Mobilization Techniques on Pain, and Hip and Knee Range of Motion on Lumbosacral Radiculopathy Patients With Peripheral Sensitization
- ClinicalTrials.gov ID
- NCT03621878
- Acronym / sponsor ID
- IRB-2014-04-321
- Conditions
- Radiculopathy
- Keywords
- Lumbosacral radiculopathy, peripheral sensitization, Neural mobilization, radicular LBP, slider, tensioner
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Mohammed Al-GhamdiUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Posted 22 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study was to investigate the effects of slider and tensioner techniques on pain, hip and knee ROM in lumbosacral radiculopathy patients with peripheral sensitization. A secondary purpose was to evaluate the correlation between these outcomes measurements.
Detailed description
Study design: Double-blind case-control trial. Methods: Fifty-one male lumbosacral radiculopathy patients with peripheral sensitization, were divided into one of the three groups: slider, tensioner, and control. The primary outcome measurements were visual analog scale (VAS) for pain, hip range of motion (ROM) during SLR test, and knee flexion ROM during slump test. The measurements were taken at baseline, after 1st, 3rd, and 6th session.
Statistical Analysis: A two-way mixed design analysis of variance (MANOVA) with post-hoc (Bonferonni Correction) was used to calculate the differences with Time (baseline, 1st,3rd,6th sessions) as a within-group factor and Group (control, slider, and tensioner) as a between-group factor. The effect size was calculated with Cohen's d. Pearson's correlation was used for correlation analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Transcutaneous Electrical Nerve Stimulation (TENS)Patients in this group had 6 sessions in 2 weeks of Transcutaneous Electric Nerve Stimulation (TENS). |
| Tensioner Group | Experimental | Other: Neural mobilization exercises -Tensioner techniquePatients in this group had 6 sessions in 2 weeks of TENS combined with neural mobilization exercises (Tensioner technique). |
| Slider Group | Experimental | Other: Neural mobilization exercises -Slider techniquePatients in this group had 6 sessions in 2 weeks of TENS combined with neural mobilization exercises (Slider technique). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with lumbosacral radiculopathy with dominant peripheral sensitization
- patients with unilateral leg pain.
- patient S-LANSS score > 12,
- negative sensory and motor examination.
- positive neural tissue provocation tests (straight leg raising test, slump test).
Key exclusion criteria (5 listed)
- S-LANSS score ≥ 12,
- motor or sensory deficits,
- history of back or lower extremity surgeries,
- bilateral referred pain,
- patients with pacemakers, cardiovascular problems, epilepsy, active malignancy, dermatological conditions, and diminished pain sensation.
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 mobilization exercises -Tensioner techniqueExercise aiming to lengthen the neural structure using more than one joint. | Other | Tensioner Group |
| Neural mobilization exercises -Slider techniqueExercise aiming to slide/glide the neural structure using more than one joint. | Other | Slider Group |
| Transcutaneous Electrical Nerve Stimulation (TENS)Also: ControlElectrotherapy device aiming to decrease patient's symptoms. | Other | Control group |
Primary outcome
Visual Analog Scale
Time frame: The measurements were taken at days "0,1,5,12"
Visual analog scale was used to measure pain intensity. This scale is a 10 cm line where patients chose from 0 to 10 (when 0 mean no pain and 10 mean maximum pain)
Hip Flexion Range of Motion (Symptomatic Side)
Time frame: The measurements were taken at days "0,1,5,12"
Change in Hip flexion range of motion during straight leg raising (symptomatic side)
Knee Flexion Range of Motion (Symptomatic Side)
Time frame: The measurements were taken at days "0,1,5,12"
Change in Knee flexion range of motion during slump (symptomatic side)
Hip Flexion Range of Motion (Asymptomatic Side)
Time frame: The measurements were taken at days "0,1,5,12"
Change in Hip Flexion Range of Motion During Straight Leg Raising (Asymptomatic Side)
Knee Flexion Range of Motion (Asymptomatic Side)
Time frame: The measurements were taken at days "0,1,5,12"
Change in Knee flexion range of motion during slump (Asymptomatic side)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Neural mobilization exercises -Tensioner technique, Neural mobilization exercises -Slider technique and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Radiculopathy, run by Mohammed Al-Ghamdi.
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 7 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 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 22 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: The measurements were taken at days "0,1,5,12"). The study lists 5 primary outcomes in all. 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 1 Mar 2023.