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Completed

NCT Number: NCT04498338

Neural Mobilization and Conventional Physical Therapy After Laminectomy

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.

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Key information

Conditions

Laminectomy

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Conventional physical therapy program

Other

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

Primary outcomes

  1. Pain intensity

    Time frame: 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.

  2. Nerve root compression

    Time frame: 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 outcomes

  1. Functional ability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 4, 2020
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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