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Changes of Pain and Functional Parameters in Back Pain Patients Over Time

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ClinicalTrials.gov Identifier: NCT03689400
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : June 7, 2019
Sponsor:
Collaborator:
Cantonal Hospital of Grisons
Information provided by (Responsible Party):
University of Applied Sciences and Arts of Southern Switzerland

Brief Summary:

Back pain affects patients' daily life. Patients can suffer from various symptoms which appear intermittent or permanent; pain, sensory malfunction, reduction of muscular strength and coordination. Therefore, patients are impaired in participation and activity.

Physiotherapy is recommended to improve those symptoms and to positively affect the cause of the problem. However, some patients do not benefit from physiotherapeutic treatment and require a surgery.

The investigators intend to attend patients suffering from back pain and to document the changes of pain and functional parameters over a period of 6 months. The investigators include pre-operative, post-operative or non-operated patients which allows to discuss the different treatment options and its effects.


Condition or disease
Changes Over Time in Pain and Functional Parameters

Detailed Description:

To assess pain and functional parameters physicians, medical staff and physiotherapist often use subjective clinical testings which impede the comparability of testings over time, between testers and between subjects.

Therefore, a second aim of this study is to evaluate each subjective clinical test with a standardized objective measurement tool.


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Changes of Pain and Functional Parameters in Back Pain Patients With or Without Radiculopathy Over Time
Actual Study Start Date : October 11, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain




Primary Outcome Measures :
  1. Changes from baseline pain sensation at 6 weeks and 6 months [ Time Frame: 3 measurement time points through study completion, an average of 6 months ]
    Changes of pain, sensory malfunction and numbness assessed by pain drawings and the visual analog scale. The visual analog scale ranges from 0 to 10 points, where 0 indicates no pain, no numbness or no impairment of sensation and 10 stands for the highest pain value, total numbness or unsustainable paresthesia.


Secondary Outcome Measures :
  1. Changes from baseline neurological status at 6 weeks and 6 months [ Time Frame: 3 measurement time points through study completion, an average of 6 months ]
    The neurological status will be assessed by the straight leg raise test. The hydrogoniometer serves as assessment tool and measures the range of motion in degrees. The test will be performed following its description and will be stopped when the patient recognises his symptoms or when more than 70 degrees of hip flexion are reached without causing any symptoms.

  2. Changes from baseline tissue tenderness status at 6 weeks and 6 months [ Time Frame: 3 measurement time points through study completion, an average of 6 months ]
    The neurological status will be assessed by the pressure pain threshold over tenderpoints along the ilica crest. The NOD-algometer device serves as assessment tool and measures the pressure pain threshold in kPa.

  3. Changes from baseline reflex activity status at 6 weeks and 6 months [ Time Frame: 3 measurement time points through study completion, an average of 6 months ]
    The neurological status will be assessed by the reflex activity of the patellar and achilles tendon reflex. An acceleration attached to the moving limb will measure the amplitude of the limb movement in m/s2.

  4. Changes from baseline muscular strength at 6 weeks and 6 months [ Time Frame: 3 measurement time points through study completion, an average of 6 months ]
    Muscular strength will be assessed by an handheld dynamometer measuring in Newton.

  5. Changes from baseline balance at 6 weeks and 6 months [ Time Frame: 3 measurement time points through study completion, an average of 6 months ]
    Balance during the one leg stance with eyes open will be assessed by the SwayStar measurement tool which is based on integrated gyroscopes to measure pitch and roll movements.

  6. Changes from baseline quality of life at 6 weeks and 6 months [ Time Frame: 3 measurement time points through study completion, an average of 6 months ]
    Quality of life will be assessed by the SF-36 questionnaire. The total score is calculated from subscales by adding the points. The total score ranges from 0 to 100 points. 0 indicates a low quality of life and 100 indicates a high quality of life.

  7. Changes from baseline disability at 6 weeks and 6 months [ Time Frame: 3 measurement time points through study completion, an average of 6 months ]
    Disability will be assessed by the German version of the Oswestry Disability Questionnaire. The total score is calculated from subscales by adding the points. The total score ranges from 0 to 50 points. 0 indicates no disability, 50 indicates a high degree of disability.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The investigators are looking for subjects suffering from back pain, who visit the neurosurgery department of the Cantonal hospital of Grisons in Chur to discuss the further treatment of their disease. The subjects get their normal medical and physiotherapeutical treatment independent of the study participation.
Criteria

Inclusion Criteria:

  • appointment at the neurosurgery department due to back pain
  • German speaking
  • willingness to see a physiotherapist
  • willingness to participate in 3 measurements over 6 months

Exclusion Criteria:

  • no appointment at the neurosurgery department due to back pain
  • not German speaking
  • no willingness to see a physiotherapist
  • no willingness to participate in 3 measurements over 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689400


Contacts
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Contact: Ron Clijsen, PhD +41813000175 ron.clijsen@supsi.ch
Contact: Christian Zweifel, PD Dr. med. +41812566233 christian.zweifel@ksgr.ch

Locations
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Switzerland
Cantonal Hospital of Grisons Recruiting
Chur, Grisons, Switzerland, 7000
Contact: Christian Zweifel, PD Dr. med.    +41812566233    christian.zweifel@ksgr.ch   
Contact: Rahel Stoop, MSc    +41813000175    rahel.stoop@supsi.ch   
Sponsors and Collaborators
University of Applied Sciences and Arts of Southern Switzerland
Cantonal Hospital of Grisons
Investigators
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Principal Investigator: Ron Clijsen, PhD SUPSI Landquart, Switzerland

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Responsible Party: University of Applied Sciences and Arts of Southern Switzerland
ClinicalTrials.gov Identifier: NCT03689400     History of Changes
Other Study ID Numbers: KSGR
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms