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Completed

NCT Number: NCT03488498

Weight Bath Traction in Chronic Low Back Pain

It is typical of chronic low back pain that, after the first painful episode, is repeated at 44-78% of patients. For acute lumbar pain, approx. 10-15% of them are converted into chronic. Conservative treatments are few studies done in the traction therapy. A large number of multicenter trials did not evaluate the effectiveness of underwater traction therapy.

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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

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Polyclinic of the Hospitaller Brothers of St. John of God,

Budapest, Árpád Fejedelem Útja 7, 1027, Hungary

About this study

Goals are the followings:

  • Is the beneficial effect of a weight bath comparable to a non-treated control group with respect to clinical parameters?
  • How much does the quality of life change in an initial state and how much is it in comparison with the control group?

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • at least 12 weeks of non-specific lymphatic pain,
  • the pain sensitivity of the paravertebral muscle and the painful movement of the lumbar spine can be observed, which can be characterized by segmental motion, segmental instability or other reasons
  • radiographically confirmed spondylosis, discopathy, and spondylarthrosis within one year.
  • back pain at least 30mm (100mm visualis analogue scale).
  • patients could not received systemic or locally administered steroid therapy, physiotherapy or they get balneotherapy in the last 2 months

p- atient consent form signed before the start of test

Exclusion criteria

  • The exclusion criteria included previous lumbar spine surgery,
  • progressive neurologic loss,
  • pregnancy,
  • (umbilical, hiatal, inguinal) hernia,
  • malignities,
  • infectious diseases,
  • inflammatory pathologies,
  • severe pulmonary and cardiovascular diseases,
  • uncontrolled- hypertension,
  • mental disorders,
  • incontinence,
  • Acute lower back pain;
  • Organic neurological symptoms associated with the lower back;
  • pain in the background of osteoporosis or other causes of vertebral compression is likely
  • Lack of complience,
  • Pain due to inflammatory spinal disease;
  • spondylolisthesis (which is not greater than 25% of vertebral skeleton compared to adjacent vertebrae)

Treatment and study plan

questionnaires

Other

Examination of the spinal mobilization in cm. The pain and quality of life assessment of functional status through questionnaires.

Primary outcomes

  1. prove the hypothesis that weight bath traction has favorable effect. of LBP using the change in the clinical parameters.

    Time frame: at the first visit and After at the 3 and the 12 weeks

    Change From Baseline in Pain Scores on the Visual Analog Scale at the 3 and the 12 weeks after the treatment.Pain intensity was measured by using the Visual Analog Scale (0-100 mm). Patients recorded on the VAS scale the level of low back pain at rest as well as during activity.

Secondary outcomes

  1. Secondary objective was to evaluate whether it also leads to the improvement in the quality of life.

    Time frame: at the first visit and After at the 3 and the 12 weeks

    Change From Baseline in level of disability in 10 everyday activities of daily life , the Functional disability by using the Oswestry Disability Index (ODI) .

  2. Secondary objective was to evaluate whether it also leads to the improvement in the quality of life.

    Time frame: at the first visit and After at the 3 and the 12 weeks

    the EuroQol Five Dimensions Questionnaire (EQ-5D). A self administered questionnaire instrument for measuring generic health status (health-related quality of life).

  3. Secondary objective was to evaluate whether it also leads to the improvement in the movements of the lumbal spine.

    Time frame: at the first visit and After at the 3 and the 12 weeks

    Change From Baseline in level improvements in the parameters of clinical lumbal spine movements in centimeters

Sponsors and collaborators

Lead sponsor

Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

Other

Registry information

Official study title

Multicenter Investigation Weight Bath Traction in Chronic Lumbar Spine Pain: a Controlled, Randomiezd, Single Blind Follow-up Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2018
Registry last updated
Aug 15, 2019

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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