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Weight Bath Traction in Chronic 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: NCT03488498
Recruitment Status : Completed
First Posted : April 5, 2018
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Tamas Gati, Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

Brief Summary:
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.

Condition or disease Intervention/treatment
Low Back Pain Other: questionnaires

Detailed Description:

Goals are the followings:

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

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Study Type : Observational
Actual Enrollment : 226 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Multicenter Investigation Weight Bath Traction in Chronic Lumbar Spine Pain: a Controlled, Randomiezd, Single Blind Follow-up Study
Actual Study Start Date : May 10, 2017
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Receiving NSAID medication
Receiving NSAID medication
Other: questionnaires
Examination of the spinal mobilization in cm. The pain and quality of life assessment of functional status through questionnaires.

Receiving NSAID medication and weight bath therapy, Other: questionnaires
Examination of the spinal mobilization in cm. The pain and quality of life assessment of functional status through questionnaires.

Receiving weight bath therapy, Other: questionnaires
Examination of the spinal mobilization in cm. The pain and quality of life assessment of functional status through questionnaires.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients are selected from on the Outpatients clinics of the Department of Rheumatology and Physiotherapy of Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
Criteria

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)

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): NCT03488498


Locations
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Hungary
Polyclinic of the Hospitaller Brothers of St. John of God,
Budapest, Árpád Fejedelem Útja 7, Hungary, 1027
Sponsors and Collaborators
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
Investigators
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Principal Investigator: Tamas GATI, MD Polyclinic of the Hospitaller Brothers of St. John of God,
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tamas Gati, Principal Investigator, Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
ClinicalTrials.gov Identifier: NCT03488498    
Other Study ID Numbers: 21396-3/2017/EKU
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Tamas Gati, Polyclinic of the Hospitaller Brothers of St. John of God, Budapest:
Balneotherapy
Chronic low back pain
Controlled
Randomized trial
weight bath traction
follow-up
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations