NCT04485182

Brief 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. Our goals are the followings:

  1. 1.Is the beneficial effect of a Underwater massage therapy addition to a complex physiotherapy comparable to a control group with respect to clinical parameters?
  2. 2.How much does the quality of life change in an initial state and how much is it in comparison with the control group?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

3.8 years

First QC Date

April 12, 2020

Last Update Submit

March 28, 2023

Conditions

Low Back Pain

Keywords

hydrotherapy, massage

Outcome Measures

Primary Outcomes (1)

  • 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)

    2 years

Secondary Outcomes (1)

  • Tangentor

    2 years

Study Arms (2)

First

Patients receiving Transcutaneous Electrical Nerve Stimulation + underwater massage + spine gymnastics +

Other: Underwater jet massage (Tangentor)

controll group

Patients receiving Transcutaneous Electrical Nerve Stimulation + spine gymnastics

Interventions

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.

First

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

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).
  • patient consent form signed before the start of test

You may not qualify if:

  • patients could not received systemic or locally administered steroid therapy, physiotherapy or they get balneotherapy in the last 2 months
  • previous lumbar spine surgery,
  • progressive neurologic loss,
  • pregnancy,
  • umbilical- , 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; malignity in the background;
  • Lack of complience,
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Budapest, Árpád Fejedelem Útja 7, 1027, Hungary

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
1027 Budapest Árpád fejedelem út 7.

Study Record Dates

First Submitted

April 12, 2020

First Posted

July 24, 2020

Study Start

June 1, 2019

Primary Completion

March 28, 2023

Study Completion

March 28, 2023

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations

HU(1)