Weight Bath Traction in Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03488498
• Other study ID #: 21396-3/2017/EKU
• Status: Completed
• Start date: May 10, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: August 2019
• Source: Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Hungary	Polyclinic of the Hospitaller Brothers of St. John of God,	Budapest	Árpád Fejedelem Útja 7

Sponsors (1)

Lead Sponsor	Collaborator
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prove the hypothesis that weight bath traction has favorable effect. of LBP using the change in the clinical parameters.	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	Secondary objective was to evaluate whether it also leads to the improvement in the quality of life.	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	Secondary objective was to evaluate whether it also leads to the improvement in the quality of life.	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	Secondary objective was to evaluate whether it also leads to the improvement in the movements of the lumbal spine.	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