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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.
Outcome measures are intensity of pain (VAS, Roland-Morris questionnaire) thoracic mobility (measured with computer, tape measurements, inclinometer and manually).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manipulation | Experimental | Subjects will receive 6 manipulation treatments within 3 weeks period. The manipulated segments are determined individually in baseline assessment. |
|
| TNS for thoracic spine | Sham Comparator | 6 TNS treatments at home for 20min in limited power of devices in three weeks period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manipulation vs. TNS thoracic pain | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thoracic spine pain (Visual analogue scale) | up to 49 week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Thoracic spine mobility (computer controllod spine PA measurement, tape measurements, inclinometer) | Baseline, after treatment, 3, 8, and 49 week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Work absent | Baseline, after treatment, 3, 8 and 49 week follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jani Takatalo, MD | University of Jyvaskyla | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fysioteekki | Oulu | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35257630 | Derived | 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. | |
| 32778081 | Derived | Takatalo 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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