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Recruiting NCT06216288

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

No phase Interventional Lumbosacral Radiculopathy McKenzie Derangement Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Repeated back extension exercise (McKenzie), Mechanical traction.
Who it may be relevant to
Registry conditions: Lumbosacral Radiculopathy, McKenzie Derangement Syndrome. Basic parameters: 35 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other Repeated back extension exercise (McKenzie)
    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.
  • Device Mechanical traction
    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.

Primary outcome measures

  • Soleus H-reflex amplitude [Time frame: At baseline and 6 weeks]
  • Soleus H-reflex latency [Time frame: At baseline and 6 weeks]
Secondary outcome measures (2)
  • Numerical Pain Intensity Scale [Time frame: At baseline and 6 weeks]
  • Oswestry Disability Index (ODI) [Time frame: At baseline and 6 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Ahmed ElMelhat [aelmelhat] — Cairo

Publications

  • Al-Abdulwahab S. Back extension exercises decompress the spinal root and improve standing mobility in patients with sub-acute lumbosacral radiculopathy. Somatosens Mot Res. 2016 Sep-Dec;33(3-4):196-199. doi: 10.1080/08990220.2016.1251895. Epub 2016 Nov 13. PMID 27838950
  • Vanti C, Saccardo K, Panizzolo A, Turone L, Guccione AA, Pillastrini P. The effects of the addition of mechanical traction to physical therapy on low back pain? A systematic review with meta-analysis. Acta Orthop Traumatol Turc. 2023 Jan;57(1):3-16. doi: 10.5152/j.aott.2023.21323. PMID 36939359
  • Thackeray A, Fritz JM, Childs JD, Brennan GP. The Effectiveness of Mechanical Traction Among Subgroups of Patients With Low Back Pain and Leg Pain: A Randomized Trial. J Orthop Sports Phys Ther. 2016 Mar;46(3):144-54. doi: 10.2519/jospt.2016.6238. Epub 2016 Jan 26. PMID 26813755

Identifiers

NCT: NCT06216288 · H-reflex in Radiculopathy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗