Weight Bath Traction in Chronic Low Back Pain

NCT03488498 | Completed

• 1 other identifier: 21396-3/2017/EKU
• Study Type: observational
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Balneotherapy; Chronic low back pain; Controlled; Randomized trial; weight bath traction; follow-up

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Secondary objective was to evaluate whether it also leads to the improvement in the 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 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.

  at the first visit and After at the 3 and the 12 weeks

Study Arms (3)

Receiving NSAID medication

Receiving NSAID medication

Other: questionnaires

Receiving NSAID medication and weight bath therapy,

Other: questionnaires

Receiving weight bath therapy,

Other: questionnaires

Interventions

questionnaires OTHER

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

Receiving NSAID medication; Receiving NSAID medication and weight bath therapy,; Receiving weight bath therapy,

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Polyclinic of the Hospitaller Brothers of St. John of God, Budapest: lead

Study Sites (1)

Polyclinic of the Hospitaller Brothers of St. John of God,

Budapest, Árpád Fejedelem Útja 7, 1027, Hungary

Location

Related Publications (1)

• 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.

  PMID: 32361959 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tamas GATI, MD

  Polyclinic of the Hospitaller Brothers of St. John of God,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: April 5, 2018
• Study Start: May 10, 2017
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

HU (1)