NCT03144362

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

12 months

First QC Date

May 4, 2017

Last Update Submit

May 29, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The Oxford Disability Index

    6 months

Study Arms (3)

Bilateral Sliding Technique

ACTIVE COMPARATOR
Procedure: Bilateral Sliding Techniques

Unilateral Sliding Techniques

ACTIVE COMPARATOR
Procedure: Unilateral Sliding Techniques

Standard care

NO INTERVENTION

Interventions

Bilateral Sliding Techniques

Bilateral Sliding Technique

Unilateral Sliding Techniques

Unilateral Sliding Techniques

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 8, 2017

Study Start

January 1, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

May 31, 2018

Record last verified: 2018-05

Locations