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Neurodynamic Study

NCT ID: NCT03144362

Last Updated: 2018-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sciatic Leg Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Study Groups

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Bilateral Sliding Technique

Group Type ACTIVE_COMPARATOR

Bilateral Sliding Techniques

Intervention Type PROCEDURE

Bilateral Sliding Techniques

Unilateral Sliding Techniques

Group Type ACTIVE_COMPARATOR

Unilateral Sliding Techniques

Intervention Type PROCEDURE

Unilateral Sliding Techniques

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bilateral Sliding Techniques

Bilateral Sliding Techniques

Intervention Type PROCEDURE

Unilateral Sliding Techniques

Unilateral Sliding Techniques

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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STH19135

Identifier Type: -

Identifier Source: org_study_id