Neurodynamic Intervention for Lumbar Radiculopathy

NCT03620864 | Completed DMC

• 1 other identifier: HU201531
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Lumbar Radiculopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in Neuropathic Mechanism Consideration

  Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session

• Changes in Related-Disability

  Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session

• Changes in Mechanical Sensitivity of the Sciatic Nerve

  Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session

• Changes in Pressure Pain Thresholds

  Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session

Study Arms (2)

Motor control exercise

ACTIVE COMPARATOR

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.

Other: Motor Control Exercises

Motor control exercise plus neurodynamic intervention

EXPERIMENTAL

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).

Other: Motor Control Exercise Plus Neurodynamic Intervention

Interventions

Motor Control Exercises OTHER

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

Motor Control Exercise Plus Neurodynamic Intervention OTHER

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).

Motor control exercise plus neurodynamic intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (1)

• 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.

  PMID: 31464753 DERIVED

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 8, 2018
• Study Start: August 10, 2018
• Primary Completion: October 3, 2018
• Study Completion: December 5, 2018
• Last Updated: December 17, 2018

Record last verified: 2018-12

Locations

ES (1)