Visceral Somatization and Low Back Pain.

NCT ID: NCT04694170

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-18
• Study Completion Date: 2020-01-10

Brief 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.

Detailed 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.

Conditions

Lumbar Strain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

Patients with musculoskeletal pain in the lumbar region. Patients with typical symptoms of functional dysfunction of kidney undergo conventional physiotherapy and an alternative approach by yoga set exercising and regimen restriction according to traditional Chinese medicine.

Group Type: EXPERIMENTAL

additional therapy

Intervention Type: OTHER

Using conventional physiotherapy together with additional yoga exercising and regimen restriction acc to TCM.

conventional physiotherapy

Intervention Type: OTHER

Using conventional physiotherapy only.

control group

Patients with musculoskeletal pain in the lumbar region. Patients with kidney dysfunction symptoms treated by conventional physiotherapy only.

Group Type: ACTIVE_COMPARATOR

conventional physiotherapy

Intervention Type: OTHER

Using conventional physiotherapy only.

Interventions

additional therapy

Using conventional physiotherapy together with additional yoga exercising and regimen restriction acc to TCM.

Intervention Type: OTHER

conventional physiotherapy

Using conventional physiotherapy only.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 26 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Malá Jitka

clinical researcher of physiotherapy department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jitka Malá, PhDr.Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Charles University, Faculty of physical education and sport

Locations

Charles University, Faculty of physical education and sport

Prague, , Czechia

Countries

Czechia

Other Identifiers

Sklepnikova, Kidney

Identifier Type: -

Identifier Source: org_study_id