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The Effectiveness of Short-term Massage Versus Trabert Current Therapy in Patients With Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Trabert current
Manual massage
Sponsored by
Medical University of Bialystok
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring massage, low back pain, Trabert current, Ultra-Reiz current

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • confirmed in X-ray spondyloarthrotic changes in lumbar area of spine
  • pain of lumbar area lasting than 1 year

Exclusion Criteria:

  • cardiac rythm disturbances
  • cardiac pacemaker
  • heart failure
  • pulmonary embolism
  • atherosclerosis
  • neoplasmatic diseases
  • skin lesions or purulent changes in the area of procedure
  • pregnancy
  • advanced osteoporosis
  • spine fractures
  • fever

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Patients with manual massage therapy

    Patients with Trabert current therapy

    Arm Description

    30 patients were randomly assigned to massage therapy. The procedures were performed for ten days, with weekend break. Manual massage of lumbar area was performed by certified massage therapist with the typical course of the procedure. The technique was consisted of stroking, kneading, grinding, patting and shaking. The procedure lasted twenty minutes.

    30 patients were randomly assigned to Trabert current therapy. The Trabert current was administered by 143 frequency, time of 2 ms impulse, time of break 5 ms. The current was generated by Pulsotronic ST-6D device (ZAMED©). The electric pads were placed on the lumbar area, in the middle part of spine. The anode in the lower part, near to buttocks. The intensity of current was regulated between 15-25 mA. The time of procedure lasted fifteen minutes.

    Outcomes

    Primary Outcome Measures

    pain intensity measured by NRS (numerical rating scale)
    Numerical raitng scale (NRS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. NRS is10-point scale, where 0=no pain and 10=worst possible pain.

    Secondary Outcome Measures

    quality of life measured by Oswestry Disability Index (ODI)
    is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

    Full Information

    First Posted
    December 10, 2018
    Last Updated
    December 10, 2018
    Sponsor
    Medical University of Bialystok
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03772093
    Brief Title
    The Effectiveness of Short-term Massage Versus Trabert Current Therapy in Patients With Low Back Pain
    Official Title
    The Effectiveness of Short-term Massage Versus Trabert Current Therapy in Patients With Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    September 30, 2018 (Actual)
    Study Completion Date
    October 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University of Bialystok

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background: Low back pain (LBP) is still a frequent health problem. Recurrance of symptoms leads to high absence at work. It was proved in previous studies that low back manual massage has a significant impact on pain reduction. Trabert current (TC) is common physical modality used in rehabilitation of patients with LBP. The aim of study was to assess the effectiveness of manual massage in comparison to TC in patients with LBP. Methods: Sixty patients with LBP were enrolled in to the study. In all patients discopathy and spondyloarthrosis were diagnosed. The subjects were randomly assigned to two groups: massage (I=30) and TC (II=30) therapy. The procedures were performed for ten days. Pain intensity was assessed by Numerical Rating Scale. Quality of life and the degree of disability were evaluated by Oswestry Disability Index and Roland-Morris Disability Questionnaire. Results: In both groups pain reduction and functional improvement were observed after therapy. However, better results were noticed in group I.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain
    Keywords
    massage, low back pain, Trabert current, Ultra-Reiz current

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with manual massage therapy
    Arm Type
    Active Comparator
    Arm Description
    30 patients were randomly assigned to massage therapy. The procedures were performed for ten days, with weekend break. Manual massage of lumbar area was performed by certified massage therapist with the typical course of the procedure. The technique was consisted of stroking, kneading, grinding, patting and shaking. The procedure lasted twenty minutes.
    Arm Title
    Patients with Trabert current therapy
    Arm Type
    Active Comparator
    Arm Description
    30 patients were randomly assigned to Trabert current therapy. The Trabert current was administered by 143 frequency, time of 2 ms impulse, time of break 5 ms. The current was generated by Pulsotronic ST-6D device (ZAMED©). The electric pads were placed on the lumbar area, in the middle part of spine. The anode in the lower part, near to buttocks. The intensity of current was regulated between 15-25 mA. The time of procedure lasted fifteen minutes.
    Intervention Type
    Device
    Intervention Name(s)
    Trabert current
    Other Intervention Name(s)
    Ultra-Reiz current
    Intervention Description
    Trabert current is an interrupted direct current of low frequency (143 Hz) applied via medium sized electrodes supported on a thick moist viscose sponge. These electrodes are placed near the spinal column along the thoracolumbar region. The electrodes are separated from each other by a distance of 3-4 cms.The current is passed through electrodes placed on the body. The intensity of the current is gradually increased short of pain. The feeling should be a pronounced but a comfortable 'tingling' sensation ('comfortably strong'). By doing this, the optimum current strength specific to the patient is found. The intensity of the current is slowly increased in the first few minutes as patients get used to the sensation. It is thought that this current provides pain relief, reduces muscle spasm and increases blood flow.
    Intervention Type
    Other
    Intervention Name(s)
    Manual massage
    Intervention Description
    Therapeutic massage is the manipulation of the soft tissue of whole body areas to bring about generalised improvements in health.Massage is thought to work through a mechanical action and a reflex action. A mechanical action is created by moving the muscles and soft tissues of the body using pressure and stretching movement. This mechanical action is based on breaking up fibrous tissue and loosen stiff joints.It may help heal damaged muscle, stimulate circulation, clear waste products via the lymphatic system, boost the activity of the immune system, reduce pain and tension and induce a calming effect.
    Primary Outcome Measure Information:
    Title
    pain intensity measured by NRS (numerical rating scale)
    Description
    Numerical raitng scale (NRS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. NRS is10-point scale, where 0=no pain and 10=worst possible pain.
    Time Frame
    NRS was measured before and after 10 days massage and Trabert current therapy groups
    Secondary Outcome Measure Information:
    Title
    quality of life measured by Oswestry Disability Index (ODI)
    Description
    is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
    Time Frame
    ODI was measured before and after 10 days massage and Trabert current therapy groups
    Other Pre-specified Outcome Measures:
    Title
    quality of life measured by Roland-Morris Disability Questionnaire (RMDQ)
    Description
    RMDQ is designed to assess self-rated physical disability caused by low back pain.widely. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. The questionnaire contains sentences that people have used to describe themselves when they suffer from back pain.
    Time Frame
    RMQ was measured before and after 10 days massage and Trabert current therapy groups

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: confirmed in X-ray spondyloarthrotic changes in lumbar area of spine pain of lumbar area lasting than 1 year Exclusion Criteria: cardiac rythm disturbances cardiac pacemaker heart failure pulmonary embolism atherosclerosis neoplasmatic diseases skin lesions or purulent changes in the area of procedure pregnancy advanced osteoporosis spine fractures fever

    12. IPD Sharing Statement

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