NCT01145105

Brief Summary

Low back pain ( LBP) is a significant health problem which affects about 70%-80% of the population during the course of their life . The majority of LBP is resolved within 3 months; however, up to 40% of LBP becomes chronic. One subgroup of chronic LBP is patients with sciatica. Sciatica is characterized by radiating pain to the buttock and lower limb, with or without low back pain. It has been shown in the upper limb that by positioning the contra-lateral arm in tension the investigators actually reduce tension in the ipsilateral arm. Patients, who present with symptoms like sciatica, can benefit from this maneuver (neural dynamics techniques) that reduces tension through the contra-lateral leg. Working Hypothesis: Compared with a placebo maneuver of the upper limb, the neural dynamics techniques will result in better rehabilitation of individuals with radicular LBP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jun 2010

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

First Submitted

Initial submission to the registry

May 24, 2010

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 16, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

November 10, 2011

Status Verified

July 1, 2011

Enrollment Period

1.1 years

First QC Date

May 24, 2010

Last Update Submit

November 9, 2011

Conditions

Keywords

Low back painSciaticaPainPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Efficacy of neural dynamics technique

    Efficacy will be measured by combining 5 tools 1. Oswestry disability index. 2. McGill Pain Questionnaire 3. Visual analog scale for pain assessment. 4. Lumbar flexion measurement (the distance of the tip of the index finger to the inferior angle of the Patella, measured by a measurement tape. 5. Passive SLR range of motion- measured with inclinometer

    5 weeks

Interventions

Treatment group- will receive neural mobilizations techniques, to improve movement of the sciatic nerve.

Also known as: Physiotherapy

Control group- will receive placebo treatment that will include mobilization to the upper limb. After the placebo treatment, these patients will receive neural mobilizations techniques.

Also known as: physiotherapy

Eligibility Criteria

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

You may qualify if:

  • Written consent
  • LBP with radiation to one leg, that lasts more than 6 weeks
  • Abnormal response to SLR test
  • With or without neurological signs

You may not qualify if:

  • History of spinal surgery
  • Patient with FUO
  • History of malignancies
  • Patient with saddle anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clalit Health Services, Haifa and Western Galilee District

Haifa, Israel

Location

MeSH Terms

Conditions

Low Back PainSciaticaPain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgia

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Noga Roguin Maor, MD

    clinical research unit, Clalit health services, Haifa and western Galilee district.

    PRINCIPAL INVESTIGATOR
  • Uzi Milman, MD

    clinical research unit, Clalit health services, Haifa and western Galilee district.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Uzi Milman MD, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL.

Study Record Dates

First Submitted

May 24, 2010

First Posted

June 16, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

November 10, 2011

Record last verified: 2011-07

Locations