Neural Mobilization and Conventional Physical Therapy After Laminectomy

Not Applicable

Completed

• Conditions: Laminectomy
• Interventions: Other: Neural mobilization combined with conventional physical therapy program; Other: Conventional physical therapy program

• Registration Number: NCT04498338
• Lead Sponsor: Cairo University

Brief Summary

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.

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 Timeline

• Study Start: 2019-03-31
• Primary Completion: 2020-02-27
• Study Completion: 2020-02-27
• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-31
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Study First Posted: 2020-08-04
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neural mobilization and conventional physical therapy	Neural mobilization combined with conventional physical therapy program	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.
Conventional physical therapy program	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.

Primary Outcome Measures

Name	Time	Method
Pain intensity	Up to 6 weeks	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.
Nerve root compression	Up to 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Functional ability	Up to 6 weeks	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.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Giza, Egypt