Visceral Somatization and Low Back Pain.

Lumbar Strain Clinical Trial

Official title:

Physiotherapy of Patients With Low Back Pain of Viscerovertebral Etiology.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04694170
• Other study ID #: Sklepnikova, Kidney
• Status: Completed
• Phase: N/A
• Start date: October 18, 2019
• Est. completion date: January 10, 2020

Study information

• Verified date: January 2021
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to verify the significance of the inclusion of procedures of a comprehensive therapeutic approach according to Eastern techniques to classical physiotherapy and to find out whether these Eastern techniques can contribute to the enrichment of standard physiotherapy. According to TCM and Ayurveda, another goal is to develop appropriate regimen measures to create a yoga regimen suitable for patients who have renal and bladder dysfunction according to TCM and whose main common symptom is chronic non-specific low back pain. The study is based upon comparing a four-week physiotherapy program according to the physician's indication and a physiotherapy program enriched with compiled regimen measures and yoga exercises in selected probands.

Description:

Two groups of probands were used - an experimental and control group. There were 6 probands in each group. The four-week therapy effect, which took place twice a week for 60 minutes, was compared. The control group received physiotherapy, as indicated by the physician. According to TCM and Ayurveda, the experimental group underwent physiotherapy as indicated by a doctor enriched with yoga exercises and regime measures. It was asked to perform yoga exercises daily at home. The therapy's effect was evaluated using the Short-form-36 Health-related Quality of Life Questionnaire (HRQoL), the VAS scale of pain intensity, the number of responses in the anamnestic questionnaire the author compiled the kinesiological analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 10, 2020
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Years to 54 Years

Eligibility

Inclusion Criteria:

• More than half of the answers in the anamnestic questionnaire (n = 14)

• More than half of the answers in the kinesiological analysis (n = 7)

• Lower back pain lasting longer than 12 weeks

• Degree of pain = 3 on a visual analog scale

Exclusion Criteria:

• Neurological or other structural cause of lower back or other pain key symptoms

• Serious systemic diseases (DM, heart or cancer)

• Contraindications to movements of the spine and other root joints of the body in full scope

• Pregnancy

• Simultaneous completion of another physiotherapeutic intervention, yoga exercise or treatment according to TCM

• Use of analgesics, antiphlogistics or muscle relaxants during therapy

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lumbar Strain

Intervention

Other:
• additional therapy
Using conventional physiotherapy together with additional yoga exercising and regimen restriction acc to TCM.
• conventional physiotherapy
Using conventional physiotherapy only.

Locations

Country	Name	City	State
Czechia	Charles University, Faculty of physical education and sport	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of quality of life	using Short Form 36 questionnaire, minimum 100 points, less score is the sign of better quality of life, maximum = 900 points = the worst quality of life	50 minutes
Primary	intensity of pain	visual analog scale 0-10, 0=the best and without pain, 10=the worst pain.	2 minutes