Skip to main content
OpenTrials
Completed

NCT Number: NCT04694170

Visceral Somatization and Low Back Pain.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lumbar Strain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sprains and Strains Wounds and Injuries

Age range

26 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charles University, Faculty of physical education and sport

Prague, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

additional therapy

Other

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

Conventional Physiotherapy

Other

Using conventional physiotherapy only.

Primary outcomes

  1. level of quality of life

    Time frame: 50 minutes

    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

  2. intensity of pain

    Time frame: 2 minutes

    visual analog scale 0-10, 0=the best and without pain, 10=the worst pain.

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

Physiotherapy of Patients With Low Back Pain of Viscerovertebral Etiology.

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jan 5, 2021
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.