Back to resultsEffectiveness of a Novel Neural Tissue Management to Improve Short-term Pain and Disability in Patients With Sciatica
Primary Purpose
Sciatica Pain, Physical Therapy Modalities, Manual Therapies
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical therapy treatment
Sponsored by
About this trial
This is an interventional treatment trial for Sciatica Pain focused on measuring Lumbosacral Plexus, Physical Therapy Modalities, Manual Therapies, Disability Evaluation.
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neural tissue management
Arm Description
Myofascial release technique; Hip joint mobilization technique; Cross-fiber friction over the sacroiliac joints; Neural mobilization to improve sciatic nerve excursion.
Outcomes
Primary Outcome Measures
Pain intensity
Measured by the Numerical Rating Scale (NRS 0-10)
Lumbar disability
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03663842
First Posted
September 5, 2018
Last Updated
September 6, 2018
Sponsor
Centro Universitário Augusto Motta
1. Study Identification
Unique Protocol Identification Number
NCT03663842
Brief Title
Effectiveness of a Novel Neural Tissue Management to Improve Short-term Pain and Disability in Patients With Sciatica
Official Title
Effectiveness of a Novel Neural Tissue Management to Improve Short-term Pain and Disability in Patients With Sciatica
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 10, 2010 (Actual)
Primary Completion Date
November 10, 2010 (Actual)
Study Completion Date
December 10, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitário Augusto Motta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatica Pain, Physical Therapy Modalities, Manual Therapies, Disability Evaluation
Keywords
Lumbosacral Plexus, Physical Therapy Modalities, Manual Therapies, Disability Evaluation.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neural tissue management
Arm Type
Experimental
Arm Description
Myofascial release technique; Hip joint mobilization technique; Cross-fiber friction over the sacroiliac joints; Neural mobilization to improve sciatic nerve excursion.
Intervention Type
Other
Intervention Name(s)
Physical therapy treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Measured by the Numerical Rating Scale (NRS 0-10)
Time Frame
From enrollment to end of treatment at 12 weeks
Title
Lumbar disability
Description
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.
Time Frame
From enrollment to end of treatment at 12 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renato Almeida, PhD
Organizational Affiliation
Centro Universitário Augusto Motta
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of a Novel Neural Tissue Management to Improve Short-term Pain and Disability in Patients With Sciatica
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