Low Back PainNCT03488498
Weight Bath Traction in Chronic Low Back Pain
An observational study of Low Back Pain, run by Polyclinic of the Hospitaller Brothers of St. John of God, Budapest at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- questionnaires
- How many people
- 226 participants
- Where
- 1 siteHungary
- Study dates
- 10 May 2017to 31 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- The exclusion criteria included previous lumbar spine surgery,
- progressive neurologic loss,
- pregnancy,
- (umbilical, hiatal, inguinal) hernia,
- malignities,
- infectious diseases,
Show all 17Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Polyclinic of the Hospitaller Brothers of St. John of God,
Budapest, Árpád Fejedelem Útja 7, 1027
About this study
Official title: 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.
Read the detailed description
Goals are the followings:
- Is the beneficial effect of a weight bath comparable to a non-treated control group with respect to clinical parameters?
- How much does the quality of life change in an initial state and how much is it in comparison with the control group?
- Conditions
- Low Back Pain
- Being tested
- questionnaires
- Keywords
- Balneotherapy, Chronic low back pain, Controlled, Randomized trial, weight bath traction, follow-up
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
Examination of the spinal mobilization in cm. The pain and quality of life assessment of functional status through questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Receiving NSAID medication | Receiving NSAID medication Receives: Other: questionnaires | |
| Receiving NSAID medication and weight bath therapy, | Not described Receives: Other: questionnaires | |
| Receiving weight bath therapy, | Not described Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Change From Baseline in level of disability in 10 everyday activities of daily life , the Functional disability by using the Oswestry Disability Index (ODI) .
Measured: 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).
Measured: 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
Measured: at the first visit and After at the 3 and the 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start10 May 2017
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamas Gati, Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
- Investigators
- Tamas GATI, MD, Principal investigator, Polyclinic of the Hospitaller Brothers of St. John of God,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488498
- Sponsor's protocol ID
- 21396-3/2017/EKU
- Status last verified
- Aug 2019
- First submitted
- 26 Feb 2018
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 32361959
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Investigation Weight Bath Traction in Chronic Lumbar Spine Pain: a Controlled, Randomiezd, Single Blind Follow-up Study
- ClinicalTrials.gov ID
- NCT03488498
- Acronym / sponsor ID
- 21396-3/2017/EKU
- Conditions
- Low Back Pain
- Keywords
- Balneotherapy, Chronic low back pain, Controlled, Randomized trial, weight bath traction, follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Polyclinic of the Hospitaller Brothers of St. John of God, BudapestUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is the beneficial effect of a weight bath comparable to a non-treated control group with respect to clinical parameters?
- How much does the quality of life change in an initial state and how much is it in comparison with the control group?
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Receiving NSAID medication | – | Other: questionnairesReceiving NSAID medication |
| Receiving NSAID medication and weight bath therapy, | – | Other: questionnaires |
| Receiving weight bath therapy, | – | Other: questionnaires |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- The exclusion criteria included previous lumbar spine surgery,
- progressive neurologic loss,
- pregnancy,
- (umbilical, hiatal, inguinal) hernia,
- malignities,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesExamination of the spinal mobilization in cm. The pain and quality of life assessment of functional status through questionnaires. | Other | Receiving NSAID medication, Receiving NSAID medication and weight bath therapy,, Receiving weight bath therapy, |
Primary outcome
prove the hypothesis that weight bath traction has favorable effect. of LBP using the change in the clinical parameters.
Time frame: at the first visit and After at the 3 and the 12 weeks
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.
3 secondary outcomes
Secondary objective was to evaluate whether it also leads to the improvement in the quality of life.
Time frame: 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.
Time frame: 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.
Time frame: at the first visit and After at the 3 and the 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Derived from this study: PubMed 32361959Gati 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamas GATI, MD principal investigator
Polyclinic of the Hospitaller Brothers of St. John of God,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Polyclinic of the Hospitaller Brothers of St. John of God, Budapest at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prove the hypothesis that weight bath traction has favorable effect. of LBP using the change in the clinical parameters. (time frame: at the first visit and After at the 3 and the 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03488498, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.