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

Lumbosacral Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06216288
• Other study ID #: H-reflex in Radiculopathy
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2024
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Ahmed El Melhat, PhD
• Phone: 01112595022
• Email: ahmed.elmelhat[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lumbosacral Radiculopathy
• Radiculopathy

Intervention

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.

Locations

Country	Name	City	State
Egypt	Ahmed ElMelhat [aelmelhat]	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soleus H-reflex amplitude	amplitude in millivolts (mV)	At baseline and 6 weeks
Primary	Soleus H-reflex latency	latency in milliseconds (ms)	At baseline and 6 weeks
Secondary	Numerical Pain Intensity Scale	in numbers, the score ranges from 0 to10.	At baseline and 6 weeks
Secondary	Oswestry Disability Index (ODI)	in numbers, the score ranges from 0 to 100.	At baseline and 6 weeks