Clinical trial NCT06216288: Effect of Combined Lumbar Traction and Repetitive Back Extension Exercise on H-reflex in Lumbosacral Radiculopathy
Official title: The Effects of Combined Lumbar Traction and Repeated Back Extension Exercise on H-Reflex, Pain, and Disability in Patients With Lumbosacral Radiculopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lumbosacral Radiculopathy
McKenzie Derangement Syndrome
Keywords: H-reflex
radiculopathy
McKenzie
Lumbar traction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants will be assigned to one of the 2 groups: either the control group receiving McKenzie repeated back extension exercise or the experimental group receiving combined McKenzie and Lumbar traction
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Subjects with lumbosacral Surgery.
2. Subjects with stenosis or scoliosis.
3. Subjects with cardiac problem or cancer.
4. Subjects with peripheral neuropathy.
5. Subjects with upper motor neuron injury.

Primary outcomes:
measure: Soleus H-reflex amplitude
timeFrame: At baseline and 6 weeks
measure: Soleus H-reflex latency
timeFrame: At baseline and 6 weeks
Secondary outcomes:
measure: Numerical Pain Intensity Scale
timeFrame: At baseline and 6 weeks
measure: Oswestry Disability Index (ODI)
timeFrame: At baseline and 6 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed ElMelhat [aelmelhat]
Study officials:
affiliation: Cairo University
name: Ahmed El Melhat, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.