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Completed

NCT Number: NCT03772093

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trabert current

Device

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 names: Ultra-Reiz current

Manual massage

Other

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2018
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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