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Neurodynamic Intervention for Lumbar Radiculopathy

Primary Purpose

Lumbar Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Motor Control Exercises
Motor Control Exercise Plus Neurodynamic Intervention
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Radiculopathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with a confirmed (via MRI) disc herniation at between L4 and S1 level;
  • Subjects exhibiting lumbar radiating pain in the lower extremity for at least 3 months
  • Subjects with a positive straight leg raise with symptoms reproduction

Exclusion Criteria:

  • indication for surgical intervention;
  • had a confirmed disc herniation at other lumbar levels;
  • have had any other spinal conditions such as spinal tumors or spondylolisthesis;
  • had received treatment for this condition by a physical therapist the previous 6 month;
  • pregnancy

Sites / Locations

  • Universidad Rey Juan Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Motor control exercise

Motor control exercise plus neurodynamic intervention

Arm Description

Patients will receive 8 sessions of motor control exercise program of 30 min duration for 4 weeks, twice per week. Exercises will be demonstrated to the participants by an experienced physical therapist. On each session, the therapist will correct each subject personally. Participants will be asked for practicing the exercises at home once daily for 20 minutes over the 8-week intervention period. The motor control exercise program will consist of a progression from isolated contraction of the transversus abdominis and/or isolated contraction of the multifidi to combined contraction of both transversus abdominis in different positions from supine or prone to bridging or four-point kneeling.

Patients will receive 8 sessions of motor control exercise program of 30 min duration for 4 weeks, twice per week. Exercises will be demonstrated to the participants by an experienced physical therapist. On each session, the therapist will correct each subject personally. Participants will be asked for practicing the exercises at home once daily for 20 minutes over the 8-week intervention period. The motor control exercise program will consist of a progression from isolated contraction of the transversus abdominis and/or isolated contraction of the multifidi to combined contraction of both transversus abdominis in different positions from supine or prone to bridging or four-point kneeling. In addition, participants allocated to the neurodynamic group will also receive a nerve neurodynamic slider intervention targeting the main trunk of the sciatic nerve of the affected side during al treatment sessions (n=8).

Outcomes

Primary Outcome Measures

Changes in Lower Extremity Pain Intensity
A Numerical Pain Rate Scale (NPRS, 0-10) where 0 represents no pain and 10 the maximum pain will be used to record the mean intensity of pain in the lower extremity

Secondary Outcome Measures

Changes in Neuropathic Mechanism Consideration
The Self-report Leeds Assessment of Neuropathic Symptoms and Signs Scale (S-LANSS) will be used for assessing neuropathic mechanism. The S-LANSS is a 7-item tool for identifying patients whose pain is dominated by neuropathic mechanisms. Each item is a binary response (yes or no) to the presence of symptoms (5 items) or clinical signs (2 items). The total score is 24 points and a value ≥ 12 points is indicative of a neuropathic component of pain.
Changes in Related-Disability
The Roland-Morris Disability Questionnaire will be used for assessing related-disability. The score can range from 0-24 with higher scores indicative of higher related-disability.
Changes in Mechanical Sensitivity of the Sciatic Nerve
The degrees of the straight leg raise test will be used to assess sensitivity of the sciatic nerve
Changes in Pressure Pain Thresholds
Pressure pain thresholds will be assessed with a mechanical algometer over the common peroneal and tibial nerve

Full Information

First Posted
July 24, 2018
Last Updated
December 13, 2018
Sponsor
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT03620864
Brief Title
Neurodynamic Intervention for Lumbar Radiculopathy
Official Title
Motor Control Exercises and Neurodynamic Intervention for Lumbar Radiculopathy: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
October 3, 2018 (Actual)
Study Completion Date
December 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Low back pain (LBP) is a common condition and has a significant impact on the individual in terms of pain and disability. Lumbar radiculopathy occurs often with LBP and may be the result of a lumbar herniated disc which will irritate a lumbar nerve trunk resulting in intraneural inflammation. There is evidence supporting the use of manual therapies of lumbar radiculopathy. One potential manual therapy is neurodynamic mobilization technique. No scientific evidence, based on a RCT, exists that this particular approach is beneficial for individuals with LBP and lumbar radiculopathy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor control exercise
Arm Type
Active Comparator
Arm Description
Patients will receive 8 sessions of motor control exercise program of 30 min duration for 4 weeks, twice per week. Exercises will be demonstrated to the participants by an experienced physical therapist. On each session, the therapist will correct each subject personally. Participants will be asked for practicing the exercises at home once daily for 20 minutes over the 8-week intervention period. The motor control exercise program will consist of a progression from isolated contraction of the transversus abdominis and/or isolated contraction of the multifidi to combined contraction of both transversus abdominis in different positions from supine or prone to bridging or four-point kneeling.
Arm Title
Motor control exercise plus neurodynamic intervention
Arm Type
Experimental
Arm Description
Patients will receive 8 sessions of motor control exercise program of 30 min duration for 4 weeks, twice per week. Exercises will be demonstrated to the participants by an experienced physical therapist. On each session, the therapist will correct each subject personally. Participants will be asked for practicing the exercises at home once daily for 20 minutes over the 8-week intervention period. The motor control exercise program will consist of a progression from isolated contraction of the transversus abdominis and/or isolated contraction of the multifidi to combined contraction of both transversus abdominis in different positions from supine or prone to bridging or four-point kneeling. In addition, participants allocated to the neurodynamic group will also receive a nerve neurodynamic slider intervention targeting the main trunk of the sciatic nerve of the affected side during al treatment sessions (n=8).
Intervention Type
Other
Intervention Name(s)
Motor Control Exercises
Intervention Description
Patients will receive 8 sessions of motor control exercise program of 30 min duration for 4 weeks, twice per week. Exercises will be demonstrated to the participants by an experienced physical therapist. On each session, the therapist will correct each subject personally. Participants will be asked for practicing the exercises at home once daily for 20 minutes over the 8-week intervention period. The motor control exercise program will consist of a progression from isolated contraction of the transversus abdominis and/or isolated contraction of the multifidi to combined contraction of both transversus abdominis in different positions from supine or prone to bridging or four-point kneeling.
Intervention Type
Other
Intervention Name(s)
Motor Control Exercise Plus Neurodynamic Intervention
Intervention Description
Patients will receive 8 sessions of motor control exercise program of 30 min duration for 4 weeks, twice per week. Exercises will be demonstrated to the participants by an experienced physical therapist. On each session, the therapist will correct each subject personally. Participants will be asked for practicing the exercises at home once daily for 20 minutes over the 8-week intervention period. The motor control exercise program will consist of a progression from isolated contraction of the transversus abdominis and/or isolated contraction of the multifidi to combined contraction of both transversus abdominis in different positions from supine or prone to bridging or four-point kneeling. In addition, participants allocated to the neurodynamic group will also receive a nerve neurodynamic slider intervention targeting the main trunk of the sciatic nerve of the affected side during al treatment sessions (n=8).
Primary Outcome Measure Information:
Title
Changes in Lower Extremity Pain Intensity
Description
A Numerical Pain Rate Scale (NPRS, 0-10) where 0 represents no pain and 10 the maximum pain will be used to record the mean intensity of pain in the lower extremity
Time Frame
Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
Secondary Outcome Measure Information:
Title
Changes in Neuropathic Mechanism Consideration
Description
The Self-report Leeds Assessment of Neuropathic Symptoms and Signs Scale (S-LANSS) will be used for assessing neuropathic mechanism. The S-LANSS is a 7-item tool for identifying patients whose pain is dominated by neuropathic mechanisms. Each item is a binary response (yes or no) to the presence of symptoms (5 items) or clinical signs (2 items). The total score is 24 points and a value ≥ 12 points is indicative of a neuropathic component of pain.
Time Frame
Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
Title
Changes in Related-Disability
Description
The Roland-Morris Disability Questionnaire will be used for assessing related-disability. The score can range from 0-24 with higher scores indicative of higher related-disability.
Time Frame
Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
Title
Changes in Mechanical Sensitivity of the Sciatic Nerve
Description
The degrees of the straight leg raise test will be used to assess sensitivity of the sciatic nerve
Time Frame
Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
Title
Changes in Pressure Pain Thresholds
Description
Pressure pain thresholds will be assessed with a mechanical algometer over the common peroneal and tibial nerve
Time Frame
Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with a confirmed (via MRI) disc herniation at between L4 and S1 level; Subjects exhibiting lumbar radiating pain in the lower extremity for at least 3 months Subjects with a positive straight leg raise with symptoms reproduction Exclusion Criteria: indication for surgical intervention; had a confirmed disc herniation at other lumbar levels; have had any other spinal conditions such as spinal tumors or spondylolisthesis; had received treatment for this condition by a physical therapist the previous 6 month; pregnancy
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31464753
Citation
Plaza-Manzano G, Cancela-Cilleruelo I, Fernandez-de-Las-Penas C, Cleland JA, Arias-Buria JL, Thoomes-de-Graaf M, Ortega-Santiago R. Effects of Adding a Neurodynamic Mobilization to Motor Control Training in Patients With Lumbar Radiculopathy Due to Disc Herniation: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2020 Feb;99(2):124-132. doi: 10.1097/PHM.0000000000001295.
Results Reference
derived

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Neurodynamic Intervention for Lumbar Radiculopathy

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