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

NCT ID: NCT06216288

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-20

Study Completion Date

2024-10-31

Brief Summary

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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

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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.

Conditions

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Lumbosacral Radiculopathy McKenzie Derangement Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Repeated back extension exercise (McKenzie)

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Repeated back extension exercise (McKenzie)

Intervention Type 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.

Mechanical traction

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type DEVICE

Other Intervention Names

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McKenzie Back Extension Approach mechanical lumbar traction

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed ElMelhat

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed El Melhat, PhD

Role: STUDY_DIRECTOR

Cairo University

Locations

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Ahmed ElMelhat [aelmelhat]

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed El Melhat, PhD

Role: CONTACT

01112595022

Aseel El kawam, DPT

Role: CONTACT

Facility Contacts

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Ahmed E [Elmelhat]

Role: primary

01112595022

References

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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.

Reference Type BACKGROUND
PMID: 27838950 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36939359 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26813755 (View on PubMed)

Other Identifiers

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H-reflex in Radiculopathy

Identifier Type: -

Identifier Source: org_study_id

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