Neural Mobilization and Conventional Physical Therapy After Laminectomy

Laminectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498338
• Other study ID #: Interventional
• Status: Completed
• Phase: N/A
• Start date: March 31, 2019
• Est. completion date: February 27, 2020

Study information

• Verified date: August 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 27, 2020
• Est. primary completion date: February 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laminectomy

Intervention

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.
• Conventional physical therapy program
TENs and exercise program applied 3 times/week for successive 6 weeks.

Locations

Country	Name	City	State
Egypt	Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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