Weight Bath Traction in Chronic Low Back Pain

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: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: 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?

• Study Type: Observational
• Enrollment (Actual): 226

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

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.	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

Outcome Measure	Measure Description	Time Frame
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 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 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

Collaborators and Investigators

• Sponsor: Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
• Investigators: Principal Investigator: Tamas GATI, MD, Polyclinic of the Hospitaller Brothers of St. John of God,

Publications and helpful links

General Publications

• Gati T, Czimer E, Cserhati G, Feher J, Olah M, Kulisch A, Mando Z, Bender T. A multicentre randomized controlled follow-up study of the effects of the underwater traction therapy in chronic low back pain. Int J Biometeorol. 2020 Aug;64(8):1393-1400. doi: 10.1007/s00484-020-01919-8. Epub 2020 May 2.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2017
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: follow-up; Chronic low back pain; Randomized trial; Controlled; Balneotherapy; weight bath traction
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID 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