NCT04694170

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

December 26, 2020

Last Update Submit

January 4, 2021

Conditions

Lumbar Strain

Keywords

Physiotherapylow back painChinese medicineYoga

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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 therapyOther: conventional physiotherapy

control group

ACTIVE COMPARATOR

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

Other: conventional physiotherapy

Interventions

additional therapyOTHER

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

Experimental group
conventional physiotherapyOTHER

Using conventional physiotherapy only.

Experimental groupcontrol group

Eligibility Criteria

Age26 Years - 54 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles University, Faculty of physical education and sport

Prague, Czechia

Location

MeSH Terms

Conditions

Sprains and StrainsLow Back Pain

Condition Hierarchy (Ancestors)

Wounds and InjuriesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jitka Malá, PhDr.Ph.D.

    Charles University, Faculty of physical education and sport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical researcher of physiotherapy department

Study Record Dates

First Submitted

December 26, 2020

First Posted

January 5, 2021

Study Start

October 18, 2019

Primary Completion

December 15, 2019

Study Completion

January 10, 2020

Last Updated

January 5, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)