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NCT Number: NCT06216288

Effect of Combined Lumbar Traction and Repetitive Back Extension Exercise on H-reflex in Lumbosacral Radiculopathy

The aim of the study is to investigate the effect of performing combined lumbar traction and repeated back extension exercise (McKenzie) on soleus H-reflex, pain, and disability in patients with lumbosacral radiculopathy. The main question that it aims to answer is:

Does the combination of lumbar traction and back extension exercise (McKenzie) improves soleus H-reflex, pain, and function in patient with lumbosacral radiculopathy? participants will be randomized into 2 groups: one group will include repeated back extension exercise (McKenzie Approach) without mechanical traction and the other group will include the same but in combination with mechanical traction.

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Key information

Conditions

Lumbosacral Radiculopathy McKenzie Derangement Syndrome Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Repeated back extension exercises as described by McKenzie from prone position has been widely suggested for patients with lumbosacral radiculopathy (LSR). It has been reported to decrease radicular symptoms which could be due to the decompression effect of this exercise on the compromised nerve root. Moreover, mechanical traction have a debatable effect on lumbosacral patients with little evidence that supports its effectiveness. Thus, the investigators hypothesize that performing a combination of lumbar traction and repeated back extension exercise will improve the soleus H-reflex, pain, and function of lumbosacral radiculopathy patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient with chronic unilateral lumbosacral radiculopathy (more than 3 months duration)
  • Age:35- 60 years
  • Both male and female
  • People with L5-S1 postero-lateral disc herniation or protrusion.
  • people with positive straight leg raise

Exclusion criteria

  • Subjects with lumbosacral Surgery.
  • Subjects with stenosis or scoliosis.
  • Subjects with cardiac problem or cancer.
  • Subjects with peripheral neuropathy.
  • Subjects with upper motor neuron injury.

Treatment and study plan

Repeated back extension exercise (McKenzie)

Other

repetitive back extension exercises in prone position with 1 minute hold on maximal back extension. 3 sets of 10 repetitions with 1 minute break between sets. The intervention was done 3 times per week for 6 weeks.

Other names: McKenzie Back Extension Approach

Mechanical traction

Device

The traction was applied using a 3D ActiveTrac table. This motorized split table applied static traction to the lumbar spine with the participant in a prone position. The intensity of the force of traction was 40% to 60% of the participant's body weight applied for 15 minutes. The intervention was done 3 times per week for 6 weeks.

Other names: mechanical lumbar traction

Primary outcomes

  1. Soleus H-reflex amplitude

    Time frame: At baseline and 6 weeks

    amplitude in millivolts (mV)

  2. Soleus H-reflex latency

    Time frame: At baseline and 6 weeks

    latency in milliseconds (ms)

Secondary outcomes

  1. Numerical Pain Intensity Scale

    Time frame: At baseline and 6 weeks

    in numbers, the score ranges from 0 to10.

  2. Oswestry Disability Index (ODI)

    Time frame: At baseline and 6 weeks

    in numbers, the score ranges from 0 to 100.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed El Melhat, PhD

CONTACT

[email protected]

01112595022

Aseel El kawam, DPT

CONTACT

[email protected]

70656958

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Effects of Combined Lumbar Traction and Repeated Back Extension Exercise on H-Reflex, Pain, and Disability in Patients With Lumbosacral Radiculopathy

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 22, 2024
Registry last updated
Aug 21, 2024

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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