Effect of Thoracic Mobilization on Lumbar Radiculopathy

Effect of Thoracic Spine Mobilization on Pain, Functional Disability and Proprioception in Patients With Lumbosacral Radiculopathy.

The purpose of the study will be to:

• To investigate the effect of thoracic mobilization on back and leg pain in patients with lumbosacral radiculopathy.
• To investigate the effect of thoracic mobilization on functional disability in patients with lumbosacral radiculopathy.
• To investigate the effect of thoracic mobilization on proprioception in patients with lumbosacral radiculopathy.

Study Overview

• Status: Recruiting
• Conditions: Lumbosacral Radiculopathy
• Intervention / Treatment: Other: thoracic mobilization

Detailed Description

To investigate the effect of thoracic mobilization on back and leg pain, functional disability and proprioception in patients with lumbosacral radiculopathy.

1-Thirty four patients of both sexes with unilateral chronic lumbar radiculopathy at L4-L5 or/ and L5-S1 levels will participate in this study. The patients will be diagnosed as having lumbar radiculopathy based on careful clinical examination by neurologist . The diagnosis will be confirmed by CT scan or MRI.

Patients will be recruited from the outpatient clinic of Faculty of Physical Therapy, Cairo University and private clinics. Patients in this study will be randomly divided into two groups.

• Group (I) which will include 17 patients who will receive manual mobilization exercises in addition to selected physical therapy .
• Group (II) which will include 17 patients who will receive selected physical therapy.

The treatment will conducted 3 sessions per week for 6 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: aya abd elmohsen, Bachelor's; Phone Number: 01122935258; Email: ayamohsen214@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of Physical Therapy Cairo University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Patients with unilateral chronic lumbosacral radiculopathy at L4- L5 or / and L5-S1 levels confirmed by MRI.
2. The age of patients will be ranged from 30 to 45 years.
3. Duration of pain will be more than 12 weeks.
4. Patients with a positive straight leg raising (SLR) test.
5. Patients with sufficient cognitive abilities that enables them to understand and follow instructions .
6. Patients had to report an average pain level of more than five on the Visual Analogue Scale (VAS) and a lumbar spine range of motion (ROM) of at least 50% of the accepted normal range.
7. Patients with body mass index< 30kg/m2

Exclusion Criteria:

1. Cauda equina syndrome.
2. Ankylosing spondylitis, thoracic deformities (pectus carinatum, excavatum), spina bifida, fractures, postoperative spinal conditions, diabetes, inflammatory processes.
3. Previous inner ear infection or vestibular disorder with unresolved balance disturbance, history of head trauma with residual neurological deficits.
4. Spinal tumor.
5. Previous lumbar surgery.
6. Sever musculoskeletal disease.
7. Peripheral mononeuropathies or polyneuropathy.
8. Obesity .
9. Pregnancy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: thoracic mobilization group; which will include 17 patients who will receive thoracic manual mobilization exercises in addition to selected physical therapy .The treatment will conducted for 45 minutes, 3 sessions per week for 6 weeks.	Other: thoracic mobilization; Thoracic mobilization will be performed for the thoracic spine mobilization group, thoracic mobilization therapy will be performed for five minutes.
No Intervention: control group; which will include 17 patients who will receive selected physical therapy.The treatment will conducted for 45 minutes, 3 sessions per week for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional disability	we will use Oswestry Disability Index (ODI)	baseline
pain level	we will use Visual analogue scale (VAS)	baseline
lumbar proprioception	we will use The Biodex System 3 pro isokinetic dynamometer	baseline

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Nagwa Ibrahim Rehab, Assistant Professor, physical therapy for neuromuscular disorder and its surgery; Study Chair: Ebtesam Mohamed Fahmy, Professor, Faculty of Medicine; Study Chair: HOSSAM MOHAMMED MOHAMMED, Lecturer, physical therapy for neuromuscular disorder and its surgery

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: thoracic mobilization in LR

Drug and device information, study documents

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