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

NCT06216288 | Recruiting

• 1 other identifier: H-reflex in Radiculopathy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbosacral Radiculopathy; McKenzie Derangement Syndrome

Keywords

H-reflex; radiculopathy; McKenzie; Lumbar traction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Numerical Pain Intensity Scale

  At baseline and 6 weeks

• Oswestry Disability Index (ODI)

  At baseline and 6 weeks

Study Arms (2)

repeated back extension exercise (McKenzie)

ACTIVE COMPARATOR

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)

Combined mechanical lumbar traction and repeated back extension exercise (McKenzie)

EXPERIMENTAL

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); Device: Mechanical traction

Interventions

Repeated back extension exercise (McKenzie) OTHER

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.

Also known as: McKenzie Back Extension Approach

Combined mechanical lumbar traction and repeated back extension exercise (McKenzie); repeated back extension exercise (McKenzie)

Mechanical traction DEVICE

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.

Also known as: mechanical lumbar traction

Combined mechanical lumbar traction and repeated back extension exercise (McKenzie)

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed ElMelhat [aelmelhat]

Cairo, Egypt

RECRUITING

Related 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.

  PMID: 27838950 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Ahmed El Melhat, PhD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Ahmed El Melhat, PhD

CONTACT

01112595022; ahmed.elmelhat@cu.edu.eg

Aseel El kawam, DPT

CONTACT

70656958; aseelkawam@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 22, 2024
• Study Start: January 20, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

EG (1)