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

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

Study Overview

• Status: Recruiting
• Conditions: Lumbosacral Radiculopathy; McKenzie Derangement Syndrome
• Intervention / Treatment: Other: Repeated back extension exercise (McKenzie); Device: 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed El Melhat, PhD; Phone Number: 01112595022; Email: ahmed.elmelhat@cu.edu.eg
• Study Contact Backup: Name: Aseel El kawam, DPT; Phone Number: 70656958; Email: aseelkawam@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ahmed ElMelhat [aelmelhat]
    • Contact: Ahmed E [Elmelhat]; Phone Number: 01112595022; Email: ahmed.elmelhat@cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: repeated back extension exercise (McKenzie); Repeated back extension exercise as described by McKenzie in prone position was performed of three sets of ten repetitions with one minute rest between the sets. The patient was asked to reach the maximum extension possible in all attempts and maintain this position for one second. The intervention was done 3 times per week for 6 weeks.	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.; Other Names: McKenzie Back Extension Approach
Experimental: Combined mechanical lumbar traction and repeated back extension exercise (McKenzie); Participants allocated to mechanical lumbar traction received the McKenzie approach described above in combination with mechanical lumbar traction. The traction was applied using a 3D ActiveTrac table which is a motorized split table. Participants were placed in prone position and static traction was applied for 15 minutes at an intensity of 40% to 60% of the participant's body weight. At the end of traction intervention, participants continued with the McKenzie repeated back extension exercise intervention. The intervention was done 3 times per week for 6 weeks.	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.; Other Names: McKenzie Back Extension Approach; 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.; Other Names: mechanical lumbar traction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soleus H-reflex amplitude	amplitude in millivolts (mV)	At baseline and 6 weeks
Soleus H-reflex latency	latency in milliseconds (ms)	At baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Pain Intensity Scale	in numbers, the score ranges from 0 to10.	At baseline and 6 weeks
Oswestry Disability Index (ODI)	in numbers, the score ranges from 0 to 100.	At baseline and 6 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Ahmed El Melhat, PhD, Cairo University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• The Effect of Back Extension Exercise on H Reflex in Patients with Lumbosacral Radiculopathy

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: H-reflex; radiculopathy; McKenzie; Lumbar traction
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: H-reflex in Radiculopathy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No