Neurodynamic Study

Sciatic Leg Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144362
• Other study ID #: STH19135
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: May 2018
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Sciatic Leg Pain

Intervention

Procedure:
• Bilateral Sliding Techniques
Bilateral Sliding Techniques
• Unilateral Sliding Techniques
Unilateral Sliding Techniques

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Roland Morris Disability Questionnaire	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	The Oxford Disability Index	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