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Visceral Somatization and Low Back Pain.

Primary Purpose

Lumbar Strain

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
additional therapy
conventional physiotherapy
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lumbar Strain focused on measuring Physiotherapy, low back pain, Chinese medicine, Yoga

Eligibility Criteria

26 Years - 54 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charles University, Faculty of physical education and sport

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 26, 2020
Last Updated
January 4, 2021
Sponsor
Charles University, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT04694170
Brief Title
Visceral Somatization and Low Back Pain.
Official Title
Physiotherapy of Patients With Low Back Pain of Viscerovertebral Etiology.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 18, 2019 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
January 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Strain
Keywords
Physiotherapy, low back pain, Chinese medicine, Yoga

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Patients with musculoskeletal pain in the lumbar region. Patients with kidney dysfunction symptoms treated by conventional physiotherapy only.
Intervention Type
Other
Intervention Name(s)
additional therapy
Intervention Description
Using conventional physiotherapy together with additional yoga exercising and regimen restriction acc to TCM.
Intervention Type
Other
Intervention Name(s)
conventional physiotherapy
Intervention Description
Using conventional physiotherapy only.
Primary Outcome Measure Information:
Title
level of quality of life
Description
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
Time Frame
50 minutes
Title
intensity of pain
Description
visual analog scale 0-10, 0=the best and without pain, 10=the worst pain.
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jitka Malá, PhDr.Ph.D.
Organizational Affiliation
Charles University, Faculty of physical education and sport
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charles University, Faculty of physical education and sport
City
Praha
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Visceral Somatization and Low Back Pain.

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