Effectiveness of a Novel Neural Tissue Management to Improve Short-term Pain and Disability in Patients With Sciatica

September 6, 2018 updated by: Renato Almeida, Centro Universitário Augusto Motta
Objectives: To analyse the effects of sciatic neural mobilisation, in combination to the treatment of the surrounding structures, on pain and disability. Secondly, to investigate baseline characteristics that may be associated with improvements in pain and lumbar disability. Methods: Twenty-eight patients with a clinical diagnosis of sciatica were treated with neural mobilization, joint mobilisation and soft tissue techniques. Pain intensity and lumbar disability were assessed at baseline and after treatment using a Numerical Rating Scale (0-10) and the Oswestry Disability Index (0-100), respectively. The pre- and post-intervention data were compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Low back pain with radiating leg pain and/or paresthesia below the knee that follows the L5 and/or S1 dermatomal pattern.

Exclusion Criteria:

  • History of lumbar and abdominal surgery
  • Rheumatologic syndromes (e.g. Rheumatoid arthritis);
  • Lumbar stenosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neural tissue management
Myofascial release technique; Hip joint mobilization technique; Cross-fiber friction over the sacroiliac joints; Neural mobilization to improve sciatic nerve excursion.
Other: Physical therapy treatment
All patients underwent the same techniques, and there was no modification of the intervention protocol during the study: (1) Myofascial release technique - piriformis muscle and biceps femoral muscle; (2) Hip joint mobilization; (3) Cross-fiber friction over the sacroiliac joints; (4) Neural mobilization to improve sciatic nerve excursion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: From enrollment to end of treatment at 12 weeks
Measured by the Numerical Rating Scale (NRS 0-10)
From enrollment to end of treatment at 12 weeks
Lumbar disability
Time Frame: From enrollment to end of treatment at 12 weeks.
Assessed by the Oswestry Disability Index (ODI).It consists of 10 items addressing different aspects of disability. Each item is scored from 0 to 5, with higher values representing greater disability. The sum of the item scores is divided by the total possible score (50 if all sections are completed), and the resulting total is multiplied by 100 to be described as a percentage score.
From enrollment to end of treatment at 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Universitário Augusto Motta

Investigators

  • Principal Investigator: Renato Almeida, PhD, Centro Universitário Augusto Motta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2010

Primary Completion (Actual)

November 10, 2010

Study Completion (Actual)

December 10, 2010

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 6, 2018

First Posted (Actual)

September 10, 2018

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25/2010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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