Neurodynamic Intervention for Lumbar Radiculopathy

Lumbar Radiculopathy Clinical Trial

Official title:

Motor Control Exercises and Neurodynamic Intervention for Lumbar Radiculopathy: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620864
• Other study ID #: HU201531
• Status: Completed
• Phase: N/A
• Start date: August 10, 2018
• Est. completion date: December 5, 2018

Study information

• Verified date: December 2018
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 5, 2018
• Est. primary completion date: October 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Radiculopathy

Intervention

Other:
• Motor Control Exercises
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.
• Motor Control Exercise Plus Neurodynamic Intervention
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).

Locations

Country	Name	City	State
Spain	Universidad Rey Juan Carlos	Alcorcon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
Secondary	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.	Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
Secondary	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.	Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
Secondary	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	Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
Secondary	Changes in Pressure Pain Thresholds	Pressure pain thresholds will be assessed with a mechanical algometer over the common peroneal and tibial nerve	Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session