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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772093
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Bialystok

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.


Condition or disease Intervention/treatment Phase
Low Back Pain Device: Trabert current Other: Manual massage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of Short-term Massage Versus Trabert Current Therapy in Patients With Low Back Pain
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Patients with manual massage therapy
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.
Other: Manual massage
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.

Active Comparator: Patients with Trabert current therapy
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.
Device: Trabert current
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.
Other Name: Ultra-Reiz current




Primary Outcome Measures :
  1. pain intensity measured by NRS (numerical rating scale) [ Time Frame: NRS was measured before and after 10 days massage and Trabert current therapy groups ]
    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 :
  1. quality of life measured by Oswestry Disability Index (ODI) [ Time Frame: ODI was measured before and after 10 days massage and Trabert current therapy groups ]
    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.


Other Outcome Measures:
  1. quality of life measured by Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: RMQ was measured before and after 10 days massage and Trabert current therapy groups ]
    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.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Publications:

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Responsible Party: Medical University of Bialystok
ClinicalTrials.gov Identifier: NCT03772093    
Other Study ID Numbers: R-I-002/418/2013
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Bialystok:
massage
low back pain
Trabert current
Ultra-Reiz current
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations