Clinical trial NCT03488498: Weight Bath Traction in Chronic Low Back Pain
Official title: Multicenter Investigation Weight Bath Traction in Chronic Lumbar Spine Pain: a Controlled, Randomiezd, Single Blind Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: Balneotherapy
Chronic low back pain
Controlled
Randomized trial
weight bath traction
follow-up
Lead sponsor: Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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?

Eligibility 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)

Primary outcomes:
measure: prove the hypothesis that weight bath traction has favorable effect. of LBP using the change in the clinical parameters.
timeFrame: at the first visit and After at the 3 and the 12 weeks
Secondary outcomes:
measure: Secondary objective was to evaluate whether it also leads to the improvement in the quality of life.
timeFrame: at the first visit and After at the 3 and the 12 weeks
measure: Secondary objective was to evaluate whether it also leads to the improvement in the quality of life.
timeFrame: at the first visit and After at the 3 and the 12 weeks
measure: Secondary objective was to evaluate whether it also leads to the improvement in the movements of the lumbal spine.
timeFrame: at the first visit and After at the 3 and the 12 weeks
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Polyclinic of the Hospitaller Brothers of St. John of God,
state: Árpád Fejedelem Útja 7
Study officials:
affiliation: Polyclinic of the Hospitaller Brothers of St. John of God,
name: Tamas GATI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.