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Completed

NCT Number: NCT03620864

Neurodynamic Intervention for Lumbar Radiculopathy

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

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Key information

Conditions

Lumbar Radiculopathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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).

Primary outcomes

  1. Changes in Lower Extremity Pain Intensity

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

    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 outcomes

  1. Changes in Neuropathic Mechanism Consideration

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

    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.

  2. Changes in Related-Disability

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

    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.

  3. Changes in Mechanical Sensitivity of the Sciatic Nerve

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

    The degrees of the straight leg raise test will be used to assess sensitivity of the sciatic nerve

  4. Changes in Pressure Pain Thresholds

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

    Pressure pain thresholds will be assessed with a mechanical algometer over the common peroneal and tibial nerve

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 8, 2018
Registry last updated
Dec 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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