Neural Mobilization and Conventional Physical Therapy After Laminectomy

Effects of Neural Mobilization Augmented by Traditional Physical Therapy on Pain, Functional Disability and H-reflex in Patients After Lumbar Laminectomy: a Randomized Controlled Trial

This study was conducted to evaluate the effect of addition of neural mobilization to a standard post-operative physical therapy program in patients with lumbar laminectomy.

Study Overview

• Status: Completed
• Conditions: Laminectomy
• Intervention / Treatment: Other: Neural mobilization combined with conventional physical therapy program; Other: Conventional physical therapy program

Detailed Description

After Laminectomy, patients are suffering from many problems as pain, weakness. This study was conducted on two groups of patients who underwent lumbar Laminectomy as a surgical treatment for lumbar canal stenosis. The control group received TENS and strengthening exercises, while the study group received neural mobilization in addition to the program that was given to the control group. The outcome measures include pain intensity, nerve root compression and functional level which were measured pre-treatment and post-treatment through using visual analogue scale, H-reflex latency and Oswestry Disability Index (ODI) respectively.

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

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged from 35-50 years.
• Underwent lumbar laminectomy of one or two levels.

Exclusion Criteria:

• Patients who had arthritis in the joints of the lower limbs (which would limit walking).
• Patients who had tumors, fractures or infections of the spine.
• Patients who had diabetes mellitus.
• Patients who had polyneuropathy.
• Patients who had evidence of spinal cord compression.
• Patients who had previous spinal surgery.
• Patients who had spinal stability problems (e.g. spondilo-listhesis, spondilolysis).
• Patients who had sensory loss.

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
Experimental: Neural mobilization and conventional physical therapy; Neural mobilization combined with conventional physical therapy program (Transcutaneous electrical nerve stimulation (TENs) and exercise program) were performed three times/week for 6 successive weeks.	Other: Neural mobilization combined with conventional physical therapy program; Neural mobilization of sciatic nerve combined with TENs and exercise program applied 3 times/week for successive 6 weeks.
Active Comparator: Conventional physical therapy program; Conventional physical therapy program (Transcutaneous electrical nerve stimulation (TENs) and exercise program) was performed three times/week for 6 successive weeks.	Other: Conventional physical therapy program; TENs and exercise program applied 3 times/week for successive 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	It was evaluated through visual analogue scale (VAS). Visual analogue scale (VAS) is a 10-cm line with a "0" at the left end for "no pain" and 10 at the right end for "worst possible pain", each patient was asked to indicate on the line where his pain is in relation to the two extremes by circling the number.	Up to 6 weeks
Nerve root compression	It was assessed through assessment of latency of H-reflex of S1. The participant was in prone-lying position. The active recording electrode was located on the soleus between the two heads of the gastrocnemius, while reference recording electrode was located on the Achilles tendon. The stimulation was applied at the midline in the popliteal fossa on the tibial nerve.	Up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional ability	The functional ability was evaluated by Oswestery disability index (ODI). Oswestery disability index (ODI) is a valid and reliable tool for assessment of functional ability. The minimum value of this scale is 0. The maximum value of this scale is 100. The higher scores mean worse outcome.	Up to 6 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Moussa A Sharaf, Assist Prof, cairo university, Egypt; Study Director: Khalid Z Fouda, Assist Prof, cairo university, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2019
• Primary Completion (Actual): February 27, 2020
• Study Completion (Actual): February 27, 2020

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Interventional (Oncolys BioPharma Inc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

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