Lumbar StrainNCT04694170
Visceral Somatization and Low Back Pain.
A study testing additional therapy and conventional physiotherapy in people with Lumbar Strain, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 54 years
- Conditions the study is for
- Lumbar Strain
- What is being tested?
- additional therapy and conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCzechia
- Study dates
- 18 Oct 2019to 10 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Charles University, Faculty of physical education and sport
Prague
About this study
Official title: Physiotherapy of Patients With Low Back Pain of Viscerovertebral Etiology.
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.
- Conditions
- Lumbar Strain
- Being tested
- additional therapy, conventional physiotherapy
- Keywords
- Physiotherapy, low back pain, Chinese medicine, Yoga
- Medical subject headings
- Sprains and Strains, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional therapyOther
Using conventional physiotherapy together with additional yoga exercising and regimen restriction acc to TCM.
conventional physiotherapyOther
Using conventional physiotherapy only.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: additional therapy; Other: conventional physiotherapy |
| control group | Active comparator | Patients with musculoskeletal pain in the lumbar region. Patients with kidney dysfunction symptoms treated by conventional physiotherapy only. Receives: Other: conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 50 minutes
intensity of pain
visual analog scale 0-10, 0=the best and without pain, 10=the worst pain.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start18 Oct 2019
- Primary completion15 Dec 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar StrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malá Jitka, Charles University, Czech Republic
- Investigators
- Jitka Malá, PhDr.Ph.D., Principal investigator, Charles University, Faculty of physical education and sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694170
- Sponsor's protocol ID
- Sklepnikova, Kidney
- Status last verified
- Jan 2021
- First submitted
- 26 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy of Patients With Low Back Pain of Viscerovertebral Etiology.
- ClinicalTrials.gov ID
- NCT04694170
- Acronym / sponsor ID
- Sklepnikova, Kidney
- Conditions
- Lumbar Strain
- Keywords
- Physiotherapy, low back pain, Chinese medicine, Yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: additional therapy, Other: conventional physiotherapyPatients 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. |
| control group | Active comparator | Other: conventional physiotherapyPatients with musculoskeletal pain in the lumbar region. Patients with kidney dysfunction symptoms treated by conventional physiotherapy only. |
Who may qualify
- Ages
- 26 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| additional therapyUsing conventional physiotherapy together with additional yoga exercising and regimen restriction acc to TCM. | Other | Experimental group |
| conventional physiotherapyUsing conventional physiotherapy only. | Other | Experimental group, control group |
Primary outcome
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
intensity of pain
Time frame: 2 minutes
visual analog scale 0-10, 0=the best and without pain, 10=the worst pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jitka Malá, PhDr.Ph.D. principal investigator
Charles University, Faculty of physical education and sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing additional therapy and conventional physiotherapy in people with Lumbar Strain, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of quality of life (time frame: 50 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.