Clinical trial NCT04694170: Visceral Somatization and Low Back Pain.
Official title: Physiotherapy of Patients With Low Back Pain of Viscerovertebral Etiology.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Strain
Keywords: Physiotherapy
low back pain
Chinese medicine
Yoga
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 12
Sex: ALL
Minimum age (years): 26
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: level of quality of life
timeFrame: 50 minutes
measure: intensity of pain
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Charles University, Faculty of physical education and sport
Study officials:
affiliation: Charles University, Faculty of physical education and sport
name: Jitka Malá, PhDr.Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: