Trial document




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  DRKS00004912

Trial Description

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Title

Sensory-motor assessment techniques for patients with non-specific chronic low back pain: a reliability and validity study.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to assess five non-painful clinical tests used to measure skin sensation and one movement control test applied to the lower back. This is of such interest as it might help to identify patients with chronic low back pain who could- in future physical therapy programmes- benefit from a special sensory training programme.The following tests will be investigated:Two-point Discrimination Test; Graphestesia Test; Body Image Drawing; Laterality Reconstruction Test; Movement Control Tests and the Fremantle Back Awareness Questionnaire.-
Potential Participants: Patients with NSCLBP longer than 6 months, aged between18 and 65-
Aims and Hypotheses: This study aims to:

1. Assess the reliability (inter and intra rater reliability) of the above mentioned set of simple clinical skin sensation tests and one movement control test in patients with non-specific chronic low back pain
2. Assess the concurrent validity of each of the above tests with one another as a measure of tactile acuity of the lower back.

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Brief Summary in Scientific Language

Sensory-motor assessment techniques for patients with non-specific chronic low back pain: a reliability and validity study.

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Organizational Data

  •   DRKS00004912
  •   2013/07/02
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  •   yes
  •   Approved
  •   2013-02, Ethikkommission des Deutschen Verbandes für Physiotherapie
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Secondary IDs

  •   U1111-1142-1514 
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Health Condition or Problem studied

  •   non-specific chronic low back pain
  •   M54.96 -  [generalization M54.9: Dorsalgia, unspecified]
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Interventions/Observational Groups

  •   non-specific chronic low back pain:


    Lumbar TPD threshold
    Participants will be positioned in a comfortably lying prone position on a treatment bench (plinth) with their back exposed; a pillow will be positioned under the stomach to flatten the lumbar spine and to ensure a standardized lying prone position; feet will be supported by a half role to further ensure the comfortable lying position
    • In a standardized palpation procedure the tips of the transverse processes of L3 and L5 will be located and marked a washable pen
    • Measurement Tool will be a 2-Point discriminator with a third point (Nexgen Medical Systems, Florida, USA) with a 1mm precision
    • The caliper will be applied to the skin until a first blanching of the skin
    • The caliper will be placed parallel to the spine and the transverse processes of the (randomly pre-defined area L3 or L5) will be in the centre of the caliper
    • Testing will be commenced in an ascending manner starting with no a distance of 20 mm distance between the two calipers and is increased in 5 mm steps increments
    • Participants will be advised to say ‘one’ when they feel one point and ‘two’ when they are able to differentiate two points
    • Catch trials will be included at approx. every 5 measurements by either using only one point or a distance well above an estimated threshold (widest possible position)
    • The distance at which the participant will firstly mention two points will be noted as the initial ascending threshold value, as long as this distance + 5mm is consistentently traced as two points.
    • This test procedure will be repeated 14 times, where the first 3 tests will be rated as a rehearsal, and the actual TPD threshold will be defined as the minimum distance that is correctly identified as two points in 50% of the trials.
    • This test will be carried out at two locationsone location on the lower back in lineeither with L3 and or L5 on the affected side or, when the pain is bilaterally, on a prior randomly identified side..

    Graphestesia
    • Participants will receive an information sheet with an alphabet with standardized capital letters which they will have in front of them throughout the testing
    • They will be shown a picture of the lumbar spine to demonstrate the orientation and location where the letters will be drawn
    • The letters will be drawn with the blunt end of a monofilament (picture) over the area of most pain
    • The height of the letters be approximately 1 inch.
    • A number of 60 random letters will be traced on the skin in a pre-randomized order in a consistent speed and the participants will have to identify them
    • An error rate out of 60 for will be calculated for each participant. The lower the error rate the better the score.

    Laterality reconstruction tasks (left/right trunk rotation/side bending tasks)
    • Participants will be shown pictures of the back turned/bent to the left or right and the task will be to identify whether the back is turned/bent either to the left or right as quickly as possible.
    • Participants will sit in front of a PC in a comfortable position
    • Index and middle finger of the dominant hand will be place on the corresponding response buttons ‘left arrow’ for left and ‘right arrow’ for right
    • The participants will then perform the left/right discrimination task using specilised software (‘Recognise online’, Neuro Orthopedic Group [NOI Group], Australia)
    • Testing will then be analyzed concerning error rate (accuracy of judging left or right correctly) and speed for the left/right discrimination judgment.

    Lumbo pelvic motor control tasks
    • The lumbo pelvic movement control will be evaluated by a battery of six standardized test (see Appendix 6 for Test ProtocolAppendix 4?):
    • Waiter’s Bow
    • Pelvic Tilt
    • One Leg Stance
    • Sitting knee extension
    • Quadruped position (‘rocking forward and backward’)
    • Prone lying active knee flexion
    • Crook Lying position (rehearsal test)
    • For each test, except th rehearsal testing,, participants will receive a standardized instruction by means of a picture, displaying the target alignment of pelvis and lumbar spine.
    • The participant will then receive further standardized oral instructions by the examiner and will have to replicate the demonstrated position.
    • In case the participant does not correctly understand the oral instructions, the test will once more be explained and demonstrated by the examiner.
    • The examiner will then judge whether the tasks was performed correctly using a dichotomos variable – successful or unsuccessful.
    • If not performed correctly the test will be considered unsuccessful. Or successful if the correct alignment of pelvis and lumbar spine was obtained.
    • If the test is initially unsuccesful the participant will be given another opportunity to assume the position. If they get it right on this second opportunity they will be considered successful but if they get it wrong they will be considered unsuccessful.
    • Each unsuccessful test will be scored 1, so that a score of 6 would indicate a poor ability to voluntarily adopt pelvis and lumbar spine alignments according to a target picture.

    Body image drawings
    • Participants will be positioned in front of a waist high bench with a line drawing of the posterior surface of the back only with given outlines of the thoracic spinous processes, the arm pits, gluteal folds and legs
    • Participants will be asked to draw into the outline their sense of the back including the vertebrae which they can feel without touching the body as well as the their present distribution of pain
    • The results will be interpreted qualitatively and quantitatively.
    • Qualitatively the drawing will be considered as either demonstrating distorted perception of theack or undistorted perception.
    • Quantitatively we will use a ruler to measure the maximum deviation from a criterion standard body image.

    Fremantle Back Awareness Questionnaire [FBAQ]
    • Participants will be asked to answer a German version of the FBAQ
    • For the purpose of the present reliability study a translated and back translated version will be employed in accordance with the guideline recommendations for Cross-cultural adaptation of Health Status Measures (Beaton et al, 2000)
    • The FABQ consists of 9 items scaled from 0-4 with a total score ranging from 0-36, the higher the score the poorer the perception.

    During session 1, two examiner will carry out the assessments independently from one another.
    During session two (2-7 days later) only one examiner will carry out the same assessments as for session 1.


    Additional basic demographic Data:
    Age, Gender, Height, Weight, BMI (calculated), Duration of Symptoms, working status

    Secondary Outcomes:
    Pain Intensity (Brief Pain Inventory Short Form [BPI-SF])
    Back related physical function (Roland Morris Disability Questionnaire [RMDQ]
    Anxiety and Depression (Hospital Anxiety and Depression Scale [HADS-D]
    health related quality of Life(Euroquol, [EQ-5D-3L])
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Intra-, intertester Reliablity

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Secondary Outcome

concurrent validity

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2013/06/06
  •   35
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Age: ≥18 years
Diagnosis: NSCLBP with or without leg pain. For those with leg pain the the back pain will have to be more dominant
Duration of symptoms: ≥ 6 months
Sufficient cognitive and German language skills/ability to understand both oral and written instructions and to give informed consent.
Intact skin on the lower back region.

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Exclusion Criteria

‘Red flags’ indicating serious spinal or peripheral nerve root pathologies such as osteoporotic fracture, spinal canal stenosis or tumours.

If due to receive treatment for their back pain during the two testing sessions.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Hochschule für Gesundheit Bochum
    • Mr.  Prof. Dr.  Christian  Grueneberg 
    • Universitätsstrasse 105
    • 44789  Bochum
    • Germany
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    •   0234 - 77727 620
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    • Teesside University
    • Mr.  Dr.  Cormac  Ryan 
    • Middlesbrough
    • United Kingdom
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    • Hochschule für Gesundheit
    • Ms.  Katja  Ehrenbrusthoff 
    • Universitätsstrasse 105
    • 44789  bochum
    • Germany
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    • Hochschule für Gesundheit
    • Ms.  Katja  Ehrenbrusthoff 
    • Universitätsstrasse 105
    • 44789  bochum
    • Germany
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Sources of Monetary or Material Support

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    • Hochschule für Gesundheit
    • Mr.  Prof. Dr.  Christian  Grueneberg 
    • Universitätsstrasse 105
    • 44789  Bochum
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/12/16
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Trial Publications, Results and other Documents

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