Neural Mobilization and Conventional Physical Therapy After Laminectomy

NCT ID: NCT04498338

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-31
• Study Completion Date: 2020-02-27

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.

Conditions

Laminectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Neural mobilization combined with conventional physical therapy program

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Conventional physical therapy program

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Conventional physical therapy program

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Moussa Abdelfattah Youssif Sharaf

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moussa A Sharaf, Assist Prof

Role: PRINCIPAL_INVESTIGATOR

Cairo University, Egypt

Khalid Z Fouda, Assist Prof

Role: STUDY_DIRECTOR

Cairo University, Egypt

Locations

Cairo University

Giza, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Interventional

Identifier Type: -

Identifier Source: org_study_id