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

Not Applicable

Recruiting

• Conditions: Lumbosacral Radiculopathy; McKenzie Derangement Syndrome
• Interventions: Other: Repeated back extension exercise (McKenzie); Device: Mechanical traction

• Registration Number: NCT06216288
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-01-19
• Study Start: 2024-01-20
• Study First Posted: 2024-01-22
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2024-09
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
repeated back extension exercise (McKenzie)	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.
Combined mechanical lumbar traction and repeated back extension exercise (McKenzie)	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.
Combined mechanical lumbar traction and repeated back extension exercise (McKenzie)	Mechanical traction	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.

Primary Outcome Measures

Name	Time	Method
Soleus H-reflex amplitude	At baseline and 6 weeks	amplitude in millivolts (mV)
Soleus H-reflex latency	At baseline and 6 weeks	latency in milliseconds (ms)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ahmed ElMelhat [aelmelhat]; 🇪🇬 Cairo, Egypt