PainNCT01884818
Thoracic Spine Manipulation for Patients With Thoracic Spine Pain
A study testing Manipulation vs. TNS thoracic pain in people with Pain, run by University of Jyvaskyla at 1 site in Finland.
Trial summary
The study includes two phases. In phase one the reliability of thoracic spine mobility measurements are studied in subjects with thoracic spine pain. In phase two the reliable measurements are used to measure the effects of thoracic spine manipulation in subjects with thoracic spine pain. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Pain
- What is being tested?
- Manipulation vs. TNS thoracic pain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2011to 15 Aug 2017
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Thoracic spine pain,
- 18-55 years old
Who cannot join
- Inflammatory spine disease,
- previous surgery on thoracic spine area,
- osteoporosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Manipulation for Thoracic Spine Pain and Mobility, and Reliability of Used Mobility Measurements.
The study includes two phases. In phase one the reliability of thoracic spine mobility measurements are studied in subjects with thoracic spine pain. In phase two the reliable measurements are used to measure the effects of thoracic spine manipulation in subjects with thoracic spine pain. The changes in pain is measured as well.
In second phase the control group receives TNS treatment six times at home as a placebo so that the power of TNS is limited to very low level. The number of treatments are controlled as well as the time of treatment. The treatment group receives six manipulation treatments within 3 week period. The effects are measured immediately after the treatment weeks, and 3 and 8 week follow-up. Moreover the one year follow-up will be performed by mail questionnaire.
Read the detailed description
Outcome measures are intensity of pain (VAS, Roland-Morris questionnaire) thoracic mobility (measured with computer, tape measurements, inclinometer and manually).
- Conditions
- Pain
- Being tested
- Manipulation vs. TNS thoracic pain
- Keywords
- Thoracic spine, pain, manipulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manipulation vs. TNS thoracic painOther
| Study group | Role | What they receive |
|---|---|---|
| Manipulation | Experimental | Subjects will receive 6 manipulation treatments within 3 weeks period. The manipulated segments are determined individually in baseline assessment. Receives: Other: Manipulation vs. TNS thoracic pain |
| TNS for thoracic spine | Sham comparator | 6 TNS treatments at home for 20min in limited power of devices in three weeks period. Receives: Other: Manipulation vs. TNS thoracic pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracic spine pain (Visual analogue scale)
Measured: up to 49 week follow-up
Secondary outcomes (1)
Thoracic spine mobility (computer controllod spine PA measurement, tape measurements, inclinometer)
Measured: Baseline, after treatment, 3, 8, and 49 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startAug 2011
- Primary completion1 Aug 2017
- Study completion15 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jyvaskyla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jtakatalo, University of Jyvaskyla
- Investigators
- Jani Takatalo, MD, Principal investigator, University of Jyvaskyla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884818
- Sponsor's protocol ID
- Thoracic
- Status last verified
- Aug 2017
- First submitted
- 25 Feb 2013
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Maatta J, Takatalo J, Leinonen T, Pienimaki T, Ylinen J, Hakkinen A. Lower thoracic spine extension mobility is associated with higher intensity of thoracic spine pain. J Man Manip Ther. 2022 Oct;30(5):300-308. doi: 10.1080/10669817.2022.2047270. Epub 2022 Mar 8.
PubMed 35257630Takatalo J, Ylinen J, Pienimaki T, Hakkinen A. Intra- and inter-rater reliability of thoracic spine mobility and posture assessments in subjects with thoracic spine pain. BMC Musculoskelet Disord. 2020 Aug 10;21(1):529. doi: 10.1186/s12891-020-03551-4.
PubMed 32778081
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Manipulation for Thoracic Spine Pain and Mobility, and Reliability of Used Mobility Measurements.
- ClinicalTrials.gov ID
- NCT01884818
- Acronym / sponsor ID
- Thoracic
- Conditions
- Pain
- Keywords
- Thoracic spine, pain, manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of JyvaskylaUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 24 Jun 2013 (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 study includes two phases. In phase one the reliability of thoracic spine mobility measurements are studied in subjects with thoracic spine pain. In phase two the reliable measurements are used to measure the effects of thoracic spine manipulation in subjects with thoracic spine pain. The changes in pain is measured as well.
In second phase the control group receives TNS treatment six times at home as a placebo so that the power of TNS is limited to very low level. The number of treatments are controlled as well as the time of treatment. The treatment group receives six manipulation treatments within 3 week period. The effects are measured immediately after the treatment weeks, and 3 and 8 week follow-up. Moreover the one year follow-up will be performed by mail questionnaire.
Detailed description
Outcome measures are intensity of pain (VAS, Roland-Morris questionnaire) thoracic mobility (measured with computer, tape measurements, inclinometer and manually).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manipulation | Experimental | Other: Manipulation vs. TNS thoracic painSubjects will receive 6 manipulation treatments within 3 weeks period. The manipulated segments are determined individually in baseline assessment. |
| TNS for thoracic spine | Sham comparator | Other: Manipulation vs. TNS thoracic pain6 TNS treatments at home for 20min in limited power of devices in three weeks period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Thoracic spine pain,
- 18-55 years old
Key exclusion criteria (3 listed)
- Inflammatory spine disease,
- previous surgery on thoracic spine area,
- osteoporosis
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 |
|---|---|---|
| Manipulation vs. TNS thoracic pain | Other | Manipulation, TNS for thoracic spine |
Primary outcome
Thoracic spine pain (Visual analogue scale)
Time frame: up to 49 week follow-up
1 secondary outcome
Thoracic spine mobility (computer controllod spine PA measurement, tape measurements, inclinometer)
Time frame: Baseline, after treatment, 3, 8, and 49 week follow-up
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 21 Aug 2017.
- Derived from this study: PubMed 35257630Maatta J, Takatalo J, Leinonen T, Pienimaki T, Ylinen J, Hakkinen A. Lower thoracic spine extension mobility is associated with higher intensity of thoracic spine pain. J Man Manip Ther. 2022 Oct;30(5):300-308. doi: 10.1080/10669817.2022.2047270. Epub 2022 Mar 8.
- Derived from this study: PubMed 32778081Takatalo J, Ylinen J, Pienimaki T, Hakkinen A. Intra- and inter-rater reliability of thoracic spine mobility and posture assessments in subjects with thoracic spine pain. BMC Musculoskelet Disord. 2020 Aug 10;21(1):529. doi: 10.1186/s12891-020-03551-4.
- Individual participant dataSharing planned: Yes
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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.
Jani Takatalo, MD principal investigator
University of Jyvaskyla
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manipulation vs. TNS thoracic pain in people with Pain, run by University of Jyvaskyla at 1 site in Finland.
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 2 inclusion and 3 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 21 Aug 2017. 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 Finland. 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?
Thoracic spine pain (Visual analogue scale) (time frame: up to 49 week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01884818, which also lists 2 linked publications.
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 21 Aug 2017.