Clinical trial NCT03144362: Neurodynamic Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sciatic Leg Pain
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Roland Morris Disability Questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: The Oxford Disability Index
timeFrame: 6 months
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
Study officials:
References: