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Gait in Low Back Pain Patients After Spinal Mobilization (SpinMob)

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TENS
spinal mobilization
swedish type massage
static hamstring stretch
sham treatment
Sponsored by
University of Ioannina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring spinal mobilization, manual therapy, gait analysis, low back pain, chronic

Eligibility Criteria

21 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • low back pain for over 3 months
  • recent lumbar MRI (up to 12 months)
  • able to walk without the need of walking aids

Exclusion Criteria:

  • leg length discrepancy of over 2 cm
  • history of spinal surgery
  • history of autoimmune disease
  • history of spondylolysis and spondylolisthesis
  • spinal fractures
  • pregnancy
  • respiratory and/or cardiac disease
  • history of stroke
  • hip, knee or ankle osteoarthritis
  • cauda equina syndrome
  • spinal inflammation
  • spinal tumor
  • steroid drug use in the last month
  • osteoporosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Sham Comparator

    Active Comparator

    Arm Label

    Spinal mobilization

    Sham Treatment

    Classic Physiotherapy

    Arm Description

    The individuals of the group received 5 treatments in total for 10 minutes that included: posterior to anterior spinal accessory mobilization passive physiological inter vertebral rotation The above was applied to the level that the MRI showed disc degeneration

    The investigator touched the skin overlying the low back statically for 10 minutes

    This group received static hamstring stretch for 5 minutes, TENS (2 channels biphasic pulse, 90Hz, 100μs pulse width) for 20 minutes and 15 minutes of Swedish type massage (effleurage, petrissage, kneading)

    Outcomes

    Primary Outcome Measures

    Change in the Numerical Pain Rating Scale
    this scale expresses the self rated pain levels in a 0 to 10 range with 0 meaning no pain and 10 the worst imaginable pain.
    Change in the Oswestry Low Back Pain Disability Index
    this is a self rated questionnaire that is expressed in a percentage with 0% meaning no disability and 100% meaning total disability. The minimum detectable change is reported to be 10% points
    Change in the Roland-Morris Disability Questionnaire
    The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The Roland-Morris Disability Questionnaire is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. For patients with severe disability the Oswestry disability questionnaire is recommended. in this case, we used the 24 question version in which 0 means no disability and 24 means total disability.
    Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms)
    The data was recorded using relevant software (Cortex, Calcium Solver, Skeleton Builder, DV Reference, Sky Scripting, KinTools RT). Κinetic and kinematic data were assessed and analysed at 3 different gait cycle time moments defined by the gait cycle and the amount of ground reaction force (GRF) during both left and right foot contact: moment 1 (T1) was at maximum GRF during heel strike, moment 2 (T2) at minimum GRF during mid stance, and moment 3 (T3) at maximum GRF during acceleration before toe off (http://www.oandplibrary.org/popup.asp?frmItemId=2A1E740F-13FD-4A68-B8A3-83A407795B5F&frmType=image&frmId=1). From these, we extrapolated the quotient (between R and L kinetic and kinematic data) values. A value of 1 would mean absolute symmetry between left and right side (Seliktar and Mizrahi, 1986). the participants walked for 10 times and the mean values of the best 3 measurements were used for analysis.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 23, 2015
    Last Updated
    May 3, 2017
    Sponsor
    University of Ioannina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02645123
    Brief Title
    Gait in Low Back Pain Patients After Spinal Mobilization
    Acronym
    SpinMob
    Official Title
    Gait Analysis of Chronic Low Back Pain Patients Before and After the Application of Spinal Mobilization
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2011 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Ioannina

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Introduction: patients with chronic back pain as a result of degenerated disc disease, besides pain also present with impaired gait. The purpose of this study is to evaluate both the clinical data using clinical rating scales, such as Oswestry Disability Index Greek version (ODI), Numerical Pain Rating Scale for low back pain and leg pain (NPRS) and the Roland Morris Disability Questionnaire Greek Version, and kinetic and kinematic characteristics during gait analysis in patients with chronic low back pain as a result of the degenerated disc disease (Disc Degenerative Disease), before and after application of manual therapy techniques. Methodology: for the purposes of the study, 75 patients suffering from chronic low back pain were randomly divided into 3 groups of 25 each. Each group received five sessions with the first group receiving manual therapy treatment (spinal mobilisation), the second a sham treatment and the third, classic physiotherapy (stretching exercises, TENS and massage). To evaluate the effectiveness of each treatment, the visual analog pain scale, two questionnaires (Oswestry and Roland Morris) and also an optoelectronic system for recording and analysis of gait (kinetic and kinematic data) were utilized.
    Detailed Description
    This was a randomized controlled trial comparing the efficacy of spinal mobilization with other physiotherapy interventions (stretching, TENS application and Swedish type massage) and sham treatment in a group of chronic low back pain patients. The outcome measures included three dimensional gait analysis (kinetic and kinematic data) as well as clinical indicators (numerical pain rating scale, Oswestry disability index, Roland-Moris Disability questionnaire).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Low Back Pain
    Keywords
    spinal mobilization, manual therapy, gait analysis, low back pain, chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    75 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Spinal mobilization
    Arm Type
    Experimental
    Arm Description
    The individuals of the group received 5 treatments in total for 10 minutes that included: posterior to anterior spinal accessory mobilization passive physiological inter vertebral rotation The above was applied to the level that the MRI showed disc degeneration
    Arm Title
    Sham Treatment
    Arm Type
    Sham Comparator
    Arm Description
    The investigator touched the skin overlying the low back statically for 10 minutes
    Arm Title
    Classic Physiotherapy
    Arm Type
    Active Comparator
    Arm Description
    This group received static hamstring stretch for 5 minutes, TENS (2 channels biphasic pulse, 90Hz, 100μs pulse width) for 20 minutes and 15 minutes of Swedish type massage (effleurage, petrissage, kneading)
    Intervention Type
    Device
    Intervention Name(s)
    TENS
    Intervention Description
    Enraf-Nonius Sonopuls 692
    Intervention Type
    Procedure
    Intervention Name(s)
    spinal mobilization
    Intervention Description
    passive physiological intervertebral movements and passive accessory posteroanterior mobilization
    Intervention Type
    Procedure
    Intervention Name(s)
    swedish type massage
    Intervention Description
    petrissage, effleurage, tapotement
    Intervention Type
    Procedure
    Intervention Name(s)
    static hamstring stretch
    Intervention Description
    static hamstring stretching
    Intervention Type
    Procedure
    Intervention Name(s)
    sham treatment
    Intervention Description
    touching of the skin overlying the lumbar area
    Primary Outcome Measure Information:
    Title
    Change in the Numerical Pain Rating Scale
    Description
    this scale expresses the self rated pain levels in a 0 to 10 range with 0 meaning no pain and 10 the worst imaginable pain.
    Time Frame
    before the beginning, after the end of 5 weeks and 6 months after the last treatment session for each patient
    Title
    Change in the Oswestry Low Back Pain Disability Index
    Description
    this is a self rated questionnaire that is expressed in a percentage with 0% meaning no disability and 100% meaning total disability. The minimum detectable change is reported to be 10% points
    Time Frame
    before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient
    Title
    Change in the Roland-Morris Disability Questionnaire
    Description
    The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The Roland-Morris Disability Questionnaire is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. For patients with severe disability the Oswestry disability questionnaire is recommended. in this case, we used the 24 question version in which 0 means no disability and 24 means total disability.
    Time Frame
    before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient
    Title
    Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms)
    Description
    The data was recorded using relevant software (Cortex, Calcium Solver, Skeleton Builder, DV Reference, Sky Scripting, KinTools RT). Κinetic and kinematic data were assessed and analysed at 3 different gait cycle time moments defined by the gait cycle and the amount of ground reaction force (GRF) during both left and right foot contact: moment 1 (T1) was at maximum GRF during heel strike, moment 2 (T2) at minimum GRF during mid stance, and moment 3 (T3) at maximum GRF during acceleration before toe off (http://www.oandplibrary.org/popup.asp?frmItemId=2A1E740F-13FD-4A68-B8A3-83A407795B5F&frmType=image&frmId=1). From these, we extrapolated the quotient (between R and L kinetic and kinematic data) values. A value of 1 would mean absolute symmetry between left and right side (Seliktar and Mizrahi, 1986). the participants walked for 10 times and the mean values of the best 3 measurements were used for analysis.
    Time Frame
    before the beginning and after the end of 5 weeks for each patient

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    78 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: low back pain for over 3 months recent lumbar MRI (up to 12 months) able to walk without the need of walking aids Exclusion Criteria: leg length discrepancy of over 2 cm history of spinal surgery history of autoimmune disease history of spondylolysis and spondylolisthesis spinal fractures pregnancy respiratory and/or cardiac disease history of stroke hip, knee or ankle osteoarthritis cauda equina syndrome spinal inflammation spinal tumor steroid drug use in the last month osteoporosis
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GEORGIOS O KREKOUKIAS, PT, MSc, PhD
    Organizational Affiliation
    University of Ioannina
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    IOANNIS D GELALIS, MD, PhD
    Organizational Affiliation
    University of Ioannina
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    individual participant's grade of disc degeneration has been shared as an appendix in an already published article: http://dx.doi.org/10.1080/10669817.2016.1184435. Please note that no more IPD will be shared.
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    Gait in Low Back Pain Patients After Spinal Mobilization

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