Neurodynamic Study

May 29, 2018 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

Unilateral and Bilateral Neurodynamic Sliding Techniques as a Means of Treating Non-compressive Sciatic Leg Pain: A Pilot Study for a Randomised Controlled Trial

Sciatica is a debilitating and costly condition. Prognostically, patients presenting with leg pain often have a poor recovery and some go onto have spinal surgery. However, in the absence of nerve root compression on MRI, no surgical option is viable and patients are often discharged and encouraged to self manage. Neurodynamics offers a means to treat patients with non-compressive leg pain. To date, there is no research exploring which form of neurodynamic sliding technique offers the greatest therapeutic benefit in patients presenting with sciatica. The aim of this pilot study is to calculate how many patients would be needed to run a full scale trial evaluating therapeutic efficacy. Moreover, the pilot will assess the overall workability of the study and the feasibility of patient recruitment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients who have given informed consent will be randomly allocated to one of three groups in a ratio of 1:1:1 (Control Group, Intervention Group 1, Intervention Group 2). Randomisation reduces selection bias and controls for unknown variables that may affect the outcome. Treatment allocation will occur through the use of sealed, opaque envelopes and will be implemented by the Graves Move More reception team as the patient attends the clinic. The reception staff will hand an opaque envelope to the subject for them to open. Randomisation undertaken by an independent third party improves internal validity. Patients will be treated according to the group they have been randomised to.

Data Collection, Analysis & Statistical Opinion Prior to undertaking the study, baseline socio-demographic data will be recorded (E.g. age, sex, weight, height, occupation and duration of symptoms). Pre and posttest outcome data will also be recorded for the Roland-Morris Disability Questionnaire (RMDQ) and Oswestry Disability Index 2.0 (ODI). Long-term data (I.e. 6-12 months post-treatment) will not be recorded as treatment effect is not being analysed as part of the pilot study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Sheffield, United Kingdom, S10 2JF
        • Sheffield Teaching Hospitals NHS Foundation Trust

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients presenting with sciatic leg pain or dysaesthetic symptoms into one leg, below the knee who have had lumbar/sacral nerve root compression excluded through MRI
  • Duration of symptoms greater than 12 weeks
  • Reproduction of the patients symptoms with SLR test + passive ankle dorsiflexion
  • Patients aged between 18-75 years of age (both male and female participants)

Exclusion Criteria:

  • Any form of lower limb or spinal entrapment neuropathy
  • Patients who have not had a lumbosacral MRI
  • Any contraindications to manual therapy including; cancer, cauda equina syndrome, active inflammatory arthropathies, rapidly deteriorating neurology, spinal fracture
  • Previous lumbar spinal surgery
  • Inability to undertake side lying
  • Patients unable to give informed consent

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: Randomized
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard care
Active Comparator: Bilateral Sliding Technique
Procedure: Bilateral Sliding Techniques
Bilateral Sliding Techniques
Active Comparator: Unilateral Sliding Techniques
Procedure: Unilateral Sliding Techniques
Unilateral Sliding Techniques

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Roland Morris Disability Questionnaire
Time Frame: 6 months
The questionnaire will be completed prior to treatment starting and again at the conclusion of the study. Change scores will be recorded. Roland & Fairbank (2000) advise a change score of 2-3 points on the 24-item version of the RMDQ as the minimally clinically important difference (MCID).
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Oxford Disability Index
Time Frame: 6 months
The Oxford Disability Index (ODI) accounts for the Roland Morris Disability Questionnaire shortcomings as it is more responsive to patients presenting with more chronic, and or severe disability (Roland & Fairbank, 2000). The MCID for the ODI has been specified as 4 points (Co et al, 1993). Neither questionnaire require permission to be used in this trial Again, pre and post-test data will be recorded to calculate change scores.
6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheffield Teaching Hospitals NHS Foundation Trust

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STH19135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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