The Spirometry;NCT01250860
Short-term Effects of the Simultaneous Use of Two Physiotherapeutic Methods in the Treatment of Adolescent Idiopathic Scoliosis - Pilot Study
A study testing Derotational manual therapy techniques in selected segments in spine in people with The Spirometry; and The Strength of Respiratory Muscles - MIP, MEP;, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The assessment of influence joint physiotherapy (DoboMed and OMT Kaltenborn - Evjenth) on the function of the respiratory system and the morphology of the ribcage in short-term intensive physiotherapy. Read more about this study
- Who is it for?
- Ages 10 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- The Spirometry;, The Strength of Respiratory Muscles - MIP, MEP;, Kyphosis (Plurimeter-V)
- What is being tested?
- Derotational manual therapy techniques in selected segments in spine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 sitePoland
- Study dates
- May 2009to Apr 2010
- 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 10 to 16 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- girls aged 10 to 16
- one arc right side curve
- Cobb range 12 - 40 degrees
Who cannot join
- bigger Cobb range
- double arc curve
- no parent approval
- lack of cooperation
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Silesia
Katowice, Silesian Voivodeship, 40-055
About this study
The assessment of influence joint physiotherapy (DoboMed and OMT Kaltenborn - Evjenth) on the function of the respiratory system and the morphology of the ribcage in short-term intensive physiotherapy.
- Conditions
- The Spirometry;, The Strength of Respiratory Muscles - MIP, MEP;, Kyphosis (Plurimeter-V), The Angle of Trunk Rotation in Thoracic Part
- Being tested
- Derotational manual therapy techniques in selected segments in spine, Sham therapy
- Keywords
- Manual therapy, DoboMed exercise, Spirometric test
- Medical subject headings
- Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Derotational manual therapy techniques in selected segments in spineOther
Derotational manual therapy techniques in selected segments of spine in preparation for the exercises according to the DoboMed method.
Sham therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Sham comparator | Control DoboMed group - only specific active exercises: symmetrical positions for exercising; asymmetrical active movements; thoracic spine kyphotization; transverse plane derotation; apical area involvement; concave ribs mobilization; exteroceptive facilitation; respiration-directed movements of the thorax and spine; three-dimensional displacement of vertebra; active autocorrection. Receives: Behavioral: Sham therapy |
| Experimental group | Experimental | Experimental DoboMed and Kaltenborn manual therapy. Suitable techniques were chosen according to manual examination: cervical spine; thoracic spine; lumbar spine; costovertebral articles; pelvis position. During the 15 sessions in group "DK" we used:derotational manual terapy techniques in selected segments of spine in preparation for the exercises according to the DoboMed method; the manual techniques used in continuation study were different from techniques in pilot study. Receives: Other: Derotational manual therapy techniques in selected segments in spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simultaneous use of two physiotherapeutic methods in the treatment of Adolescent Idiopathic Scoliosis
Forty-two girls with thoracic AIS; mean age - 14.5y. Cobb - (range 12-40) The group was divided into two randomized subgroups. DoboMed was applied in group "D" only. DoboMed and manual therapy (Kaltenborn) were applied in group "DK". The spirometry, the strength of respiratory muscles (maximal inspiratory and expiratory pressures- MIP, MEP), kyphosis (plurimeter-V) and the angle of trunk rotation (ATR) in thoracic part (Bunnell scoliometer) were estimated twice - before and after therapy.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startMay 2009
- Primary completionOct 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Spirometry;Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250860
- Sponsor's protocol ID
- BW-08-AM
- Status last verified
- Nov 2010
- First submitted
- 30 Nov 2010
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of the Simultaneous Use of Two Physiotherapeutic Methods in the Treatment of Adolescent Idiopathic Scoliosis - Pilot Study
- ClinicalTrials.gov ID
- NCT01250860
- Acronym / sponsor ID
- BW-08-AM
- Conditions
- The Spirometry;, The Strength of Respiratory Muscles - MIP, MEP;, Kyphosis (Plurimeter-V), The Angle of Trunk Rotation in Thoracic Part
- Keywords
- Manual therapy, DoboMed exercise, Spirometric test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 1 Dec 2010 (estimated)
- 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.
The assessment of influence joint physiotherapy (DoboMed and OMT Kaltenborn - Evjenth) on the function of the respiratory system and the morphology of the ribcage in short-term intensive physiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Sham comparator | Behavioral: Sham therapyControl DoboMed group - only specific active exercises: symmetrical positions for exercising; asymmetrical active movements; thoracic spine kyphotization; transverse plane derotation; apical area involvement; concave ribs mobilization; exteroceptive facilitation; respiration-directed movements of the thorax and spine; three-dimensional displacement of vertebra; active autocorrection. |
| Experimental group | Experimental | Other: Derotational manual therapy techniques in selected segments in spineExperimental DoboMed and Kaltenborn manual therapy. Suitable techniques were chosen according to manual examination: cervical spine; thoracic spine; lumbar spine; costovertebral articles; pelvis position. During the 15 sessions in group "DK" we used:derotational manual terapy techniques in selected segments of spine in preparation for the exercises according to the DoboMed method; the manual techniques used in continuation study were different from techniques in pilot study. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- girls aged 10 to 16
- one arc right side curve
- Cobb range 12 - 40 degrees
Key exclusion criteria (4 listed)
- bigger Cobb range
- double arc curve
- no parent approval
- lack of cooperation
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 |
|---|---|---|
| Derotational manual therapy techniques in selected segments in spineDerotational manual therapy techniques in selected segments of spine in preparation for the exercises according to the DoboMed method. | Other | Experimental group |
| Sham therapy | Behavioural | Control Group |
Primary outcome
Simultaneous use of two physiotherapeutic methods in the treatment of Adolescent Idiopathic Scoliosis
Time frame: 3 weeks
Forty-two girls with thoracic AIS; mean age - 14.5y. Cobb - (range 12-40) The group was divided into two randomized subgroups. DoboMed was applied in group "D" only. DoboMed and manual therapy (Kaltenborn) were applied in group "DK". The spirometry, the strength of respiratory muscles (maximal inspiratory and expiratory pressures- MIP, MEP), kyphosis (plurimeter-V) and the angle of trunk rotation (ATR) in thoracic part (Bunnell scoliometer) were estimated twice - before and after therapy.
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 1 Dec 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Derotational manual therapy techniques in selected segments in spine in people with The Spirometry; and The Strength of Respiratory Muscles - MIP, MEP;, run by Medical University of Silesia at 1 site in Poland.
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 3 inclusion and 4 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 1 Dec 2010. 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 Poland. 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. Some participants in this study may receive a placebo. 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?
Simultaneous use of two physiotherapeutic methods in the treatment of Adolescent Idiopathic Scoliosis (time frame: 3 weeks). 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 1 Dec 2010.