NCT03663842

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2010

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2010

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

September 5, 2018

Last Update Submit

September 6, 2018

Conditions

Keywords

Lumbosacral PlexusPhysical Therapy ModalitiesManual TherapiesDisability Evaluation.

Outcome Measures

Primary Outcomes (2)

  • Pain intensity

    Measured by the Numerical Rating Scale (NRS 0-10)

    From enrollment to end of treatment at 12 weeks

  • 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.

    From enrollment to end of treatment at 12 weeks.

Study Arms (1)

Neural tissue management

EXPERIMENTAL

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

Interventions

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.

Neural tissue management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Renato Almeida, PhD

    Centro Universitário Augusto Motta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 10, 2018

Study Start

May 10, 2010

Primary Completion

November 10, 2010

Study Completion

December 10, 2010

Last Updated

September 10, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share