Weight Bath Traction in Chronic Low Back Pain

NCT ID: NCT03488498

Last Updated: 2019-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

226 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-10

Study Completion Date

2019-01-31

Brief Summary

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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

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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?

Conditions

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Low Back Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Receiving NSAID medication

Receiving NSAID medication

questionnaires

Intervention Type OTHER

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,

questionnaires

Intervention Type OTHER

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

Receiving weight bath therapy,

questionnaires

Intervention Type OTHER

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

Interventions

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questionnaires

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

Intervention Type OTHER

Eligibility Criteria

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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

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Tamas Gati

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tamas GATI, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Budapest, Árpád Fejedelem Útja 7, Hungary

Site Status

Countries

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Hungary

References

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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.

Reference Type DERIVED
PMID: 32361959 (View on PubMed)

Other Identifiers

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21396-3/2017/EKU

Identifier Type: -

Identifier Source: org_study_id

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