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CompletedNCT04694170Updated Jan 5, 2021

Visceral Somatization and Low Back Pain.

An interventional study of additional therapy and conventional physiotherapy in Lumbar Strain, sponsored by Charles University, Czech Republic. Completed at 1 site in Czechia. Open to participants aged 26 Years to 54 Years. Per ClinicalTrials.gov, last updated 2021-01-05.

Sponsored by Charles University, Czech Republic · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Oct 2019, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
26 Years to 54 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lumbar Strain

Keywords

  • Physiotherapy
  • low back pain
  • Chinese medicine
  • Yoga
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 12 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Charles University, Czech Republic is the lead sponsor of 220 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
26 Years to 54 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Investigator)
Enrollment
12 participants (actual)

Study arms

  • 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 · Other: conventional physiotherapy

  • 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

Interventions

  • Otheradditional therapy

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

  • Otherconventional physiotherapy

    Using conventional physiotherapy only.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 50 minutes

  2. intensity of pain

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

    Time frame: 2 minutes

07

Study locations

1 site
  • Charles University, Faculty of physical education and sport
    Praha, Czechia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04694170
Lead sponsor
Charles University, Czech Republic
Responsible party
Malá Jitka (clinical researcher of physiotherapy department, Charles University, Czech Republic) — Principal investigator
First posted
Jan 5, 2021
Start date
Oct 18, 2019
Primary completion
Dec 15, 2019
Completion
Jan 10, 2020
Last update
Jan 5, 2021

Study contacts

Jitka Malá, PhDr.Ph.D.
principal investigator · Charles University, Faculty of physical education and sport

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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