Visceral Somatization and Low Back Pain.

Physiotherapy of Patients With Low Back Pain of Viscerovertebral Etiology.

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Strain
• Intervention / Treatment: Other: additional therapy; Other: conventional physiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Praha, Czechia
    • Charles University, Faculty of physical education and sport

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 54 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: additional therapy; Using conventional physiotherapy together with additional yoga exercising and regimen restriction acc to TCM.; Other: conventional physiotherapy; Using conventional physiotherapy only.
Active Comparator: control group; Patients with musculoskeletal pain in the lumbar region. Patients with kidney dysfunction symptoms treated by conventional physiotherapy only.	Other: conventional physiotherapy; Using conventional physiotherapy only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
intensity of pain	visual analog scale 0-10, 0=the best and without pain, 10=the worst pain.	2 minutes

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Investigators: Principal Investigator: Jitka Malá, PhDr.Ph.D., Charles University, Faculty of physical education and sport

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2019
• Primary Completion (Actual): December 15, 2019
• Study Completion (Actual): January 10, 2020

Study Registration Dates

• First Submitted: December 26, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Yoga; low back pain; Physiotherapy; Chinese medicine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Sklepnikova, Kidney

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No