Underwater Jet Massage Therapy for Chronic Low Back Pain

NCT ID: NCT04485182

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2023-03-28

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. 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. 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).

Conditions

Low Back Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

First

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

Underwater jet massage (Tangentor)

Intervention Type: 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.

controll group

Patients receiving Transcutaneous Electrical Nerve Stimulation + spine gymnastics

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

Exclusion Criteria

• 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,
• 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: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Tamas Gati

1027 Budapest Árpád fejedelem út 7.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Budapest, Árpád Fejedelem Útja 7, Hungary

Countries

Hungary

Other Identifiers

PolyclinicHBSJG

Identifier Type: -

Identifier Source: org_study_id