Low Back PainNCT04485182
Underwater Jet Massage Therapy for 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
Underwater massage is the more modern variety of massages otherwise known as tangentor, where the temperature of the water of the treatment tub and the mechanical effect of the water jet is utilised. It is typical of chronic low back pain that, after the first painful episode, is repeated at 44-78% of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Underwater jet massage (Tangentor)
- How many people
- 60 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jun 2019to 28 Mar 2023
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Enrollment criteria were as follows: outpatients aged 18-85 with non-specific low back pain that persists for at least 12 weeks, showing degenerative symptoms and suffering from moderately reduced mobility. Patient's pain intensity during activity should have been minimum 30mm on Visual Analogue Scale (0-100 mm VAS). Written information on the methodology and process they would be undergoing was provided to each participant, and an informed consent form was subsequently signed before the study.
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).
- patient consent form signed before the start of test
Who cannot join
- patients could not received systemic or locally administered steroid therapy, physiotherapy or they get balneotherapy in the last 2 months
- The exclusion criteria included:
- previous lumbar spine surgery,
- progressive neurologic loss,
- pregnancy,
- umbilical- , inguinal hernia,
Show all 18Show fewer
- 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; malignity in the background;
- 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
Underwater massage is the more modern variety of massages otherwise known as tangentor, where the temperature of the water of the treatment tub and the mechanical effect of the water jet is utilised. It is typical of chronic low back pain that, after the first painful episode, is repeated at 44-78% of patients.
Our goals are the followings:
- Is the beneficial effect of a Underwater massage therapy addition to a complex physiotherapy comparable to a 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?
Read the detailed description
Informed consent was obtained from all participants. We use two groups to investigate the effects of the tangentor on the low back pain.
The patients presenting at the rheumatology inpatient clinics were enrolled without into the treatment and control groups.
Patients receiving Transcutaneous Electrical Nerve Stimulation + underwater massage + spine gymnastics
In the controll group the Patients receiving Transcutaneous Electrical Nerve Stimulation + spine gymnastics
Underwater jet massage (Tangentor) would be performed in a tub developed for this purpose, where the water temperature: 33-35 ° C. The treatments lasting from 15 atm and 15 cm for 15 minutes.
The water temperature is precisely measured by a built-in thermometer. Pressure is controlled by a manometer.
They take a minimum of 10 treatments for approx. under 2 weeks.
The back massage position is, that the patient lying on their side, hip and knees are slightly bent and the head and neck rest on a support.
After the massage the client should rest for about 30minutes.
Patients participated in two visits, for the first time before the study, right after the therapy treatments.
During the study, all participants received the usual or necessary medications. On a Visual Analogue Scale (VAS) patients indicated degree of pain on a scale from 0 to 100 mm for the past week. VAS scores were expressed in millimetres (zero point-no pain; endpoint-intolerable pain). Patients recorded on the VAS scale the level of low back pain at rest as well as during activity. Functional disability was assessed by using the Oswestry Disability Index (ODI).
Furthermore, there was a questionnaire on the quality of life, known as the EuroQol Five Dimensions Questionnaire (EQ-5D-5L).
- Conditions
- Low Back Pain
- Being tested
- Underwater jet massage (Tangentor)
- Keywords
- hydrotherapy, massage
- 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.
Underwater jet massage (Tangentor)Other
Underwater jet massage (Tangentor) would be performed in a tub developed for this purpose, where the water temperature: 33-35 ° C. The treatments lasting from 15 atm and 15 cm for 15 minutes.
They take a minimum of 10 treatments for approx. under 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| First | Patients receiving Transcutaneous Electrical Nerve Stimulation + underwater massage + spine gymnastics + Receives: Other: Underwater jet massage (Tangentor) | |
| controll group | Patients receiving Transcutaneous Electrical Nerve Stimulation + spine gymnastics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tangentor
Investigate the beneficial effect of a Underwater massage therapy addition to a complex physiotherapy comparable to a control group with respect to clinical parameters on a Visual Analogue Scale (VAS)
Measured: 2 years
Secondary outcomes (1)
Tangentor
How much does the quality of life change in an initial state and how much is it in comparison with the control group on the EuroQol Five Dimensions Questionnaire (EQ-5D-5L).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Jun 2019
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Why it stopped: Due to the COVID pandemia the tubes of the treatments baths went wrong.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485182
- Sponsor's protocol ID
- PolyclinicHBSJG
- Status last verified
- Mar 2023
- First submitted
- 12 Apr 2020
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Underwater Jet Massage Therapy for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04485182
- Acronym / sponsor ID
- PolyclinicHBSJG
- Conditions
- Low Back Pain
- Keywords
- hydrotherapy, massage
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to the COVID pandemia the tubes of the treatments baths went wrong.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Polyclinic of the Hospitaller Brothers of St. John of God, BudapestUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 24 Jul 2020 (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.
Underwater massage is the more modern variety of massages otherwise known as tangentor, where the temperature of the water of the treatment tub and the mechanical effect of the water jet is utilised. It is typical of chronic low back pain that, after the first painful episode, is repeated at 44-78% of patients.
Our goals are the followings:
- Is the beneficial effect of a Underwater massage therapy addition to a complex physiotherapy comparable to a 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?
Detailed description
Informed consent was obtained from all participants. We use two groups to investigate the effects of the tangentor on the low back pain.
The patients presenting at the rheumatology inpatient clinics were enrolled without into the treatment and control groups.
Patients receiving Transcutaneous Electrical Nerve Stimulation + underwater massage + spine gymnastics
In the controll group the Patients receiving Transcutaneous Electrical Nerve Stimulation + spine gymnastics
Underwater jet massage (Tangentor) would be performed in a tub developed for this purpose, where the water temperature: 33-35 ° C. The treatments lasting from 15 atm and 15 cm for 15 minutes.
The water temperature is precisely measured by a built-in thermometer. Pressure is controlled by a manometer.
They take a minimum of 10 treatments for approx. under 2 weeks.
The back massage position is, that the patient lying on their side, hip and knees are slightly bent and the head and neck rest on a support.
After the massage the client should rest for about 30minutes.
Patients participated in two visits, for the first time before the study, right after the therapy treatments.
During the study, all participants received the usual or necessary medications. On a Visual Analogue Scale (VAS) patients indicated degree of pain on a scale from 0 to 100 mm for the past week. VAS scores were expressed in millimetres (zero point-no pain; endpoint-intolerable pain). Patients recorded on the VAS scale the level of low back pain at rest as well as during activity. Functional disability was assessed by using the Oswestry Disability Index (ODI).
Furthermore, there was a questionnaire on the quality of life, known as the EuroQol Five Dimensions Questionnaire (EQ-5D-5L).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First | – | Other: Underwater jet massage (Tangentor)Patients receiving Transcutaneous Electrical Nerve Stimulation + underwater massage + spine gymnastics + |
| controll group | – | –Patients receiving Transcutaneous Electrical Nerve Stimulation + spine gymnastics |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Enrollment criteria were as follows: outpatients aged 18-85 with non-specific low back pain that persists for at least 12 weeks, showing degenerative symptoms and suffering from moderately reduced mobility. Patient's pain intensity during activity should have been minimum 30mm on Visual Analogue Scale (0-100 mm VAS). Written information on the methodology and process they would be undergoing was provided to each participant, and an informed consent form was subsequently signed before the study.
Key inclusion criteria (4 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).
- patient consent form signed before the start of test
Key exclusion criteria (18 listed)
- patients could not received systemic or locally administered steroid therapy, physiotherapy or they get balneotherapy in the last 2 months
- The exclusion criteria included:
- previous lumbar spine surgery,
- progressive neurologic loss,
- pregnancy,
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 |
|---|---|---|
| Underwater jet massage (Tangentor)Underwater jet massage (Tangentor) would be performed in a tub developed for this purpose, where the water temperature: 33-35 ° C. The treatments lasting from 15 atm and 15 cm for 15 minutes. They take a minimum of 10 treatments for approx. under 2 weeks. | Other | First |
Primary outcome
Tangentor
Time frame: 2 years
Investigate the beneficial effect of a Underwater massage therapy addition to a complex physiotherapy comparable to a control group with respect to clinical parameters on a Visual Analogue Scale (VAS)
1 secondary outcome
Tangentor
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Due to the COVID pandemia the tubes of the treatments baths went wrong.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 4 inclusion and 18 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: stopped early, as of the sponsor's last update on 31 Mar 2023. 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 was stopped early (reason given: Due to the COVID pandemia the tubes of the treatments baths went wrong.). Results are not available in the source record.
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?
Tangentor (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2023.