Weight Bath Traction in Chronic Low Back Pain

August 14, 2019 updated by: Tamas Gati, Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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?

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
226

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Árpád Fejedelem Útja 7
      • Budapest, Árpád Fejedelem Útja 7, Hungary, 1027
        • Polyclinic of the Hospitaller Brothers of St. John of God,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at the first visit and After at the 3 and the 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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) .
at the first visit and After at the 3 and the 12 weeks
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).
at the first visit and After at the 3 and the 12 weeks
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
at the first visit and After at the 3 and the 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tamas GATI, MD, Polyclinic of the Hospitaller Brothers of St. John of God,

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21396-3/2017/EKU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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