Neural Mobilization and Conventional Physical Therapy After Laminectomy

NCT04498338 | Completed DMC

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Laminectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Functional ability

  Up to 6 weeks

Study Arms (2)

Neural mobilization and conventional physical therapy

EXPERIMENTAL

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

Conventional physical therapy program

ACTIVE COMPARATOR

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

Interventions

Neural mobilization combined with conventional physical therapy program OTHER

Neural mobilization of sciatic nerve combined with TENs and exercise program applied 3 times/week for successive 6 weeks.

Neural mobilization and conventional physical therapy

Conventional physical therapy program OTHER

TENs and exercise program applied 3 times/week for successive 6 weeks.

Conventional physical therapy program

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

Location

Study Officials

• Moussa A Sharaf, Assist Prof

  Cairo University, Egypt

  PRINCIPAL INVESTIGATOR

• Khalid Z Fouda, Assist Prof

  Cairo University, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 4, 2020
• Study Start: March 31, 2019
• Primary Completion: February 27, 2020
• Study Completion: February 27, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)