Thoracic Spine Manipulation for Patients With Thoracic Spine Pain
The Effect of Manipulation for Thoracic Spine Pain and Mobility, and Reliability of Used Mobility Measurements.
1 other identifier
interventional
78
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Aug 2011
Longer than P75 for not_applicable pain
1 active site
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
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 25, 2013
CompletedFirst Posted
Study publicly available on registry
June 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2017
CompletedAugust 21, 2017
August 1, 2017
6 years
February 25, 2013
August 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Thoracic spine pain (Visual analogue scale)
up to 49 week follow-up
Secondary Outcomes (1)
Thoracic spine mobility (computer controllod spine PA measurement, tape measurements, inclinometer)
Baseline, after treatment, 3, 8, and 49 week follow-up
Other Outcomes (1)
Work absent
Baseline, after treatment, 3, 8 and 49 week follow-up
Study Arms (2)
Manipulation
EXPERIMENTALSubjects will receive 6 manipulation treatments within 3 weeks period. The manipulated segments are determined individually in baseline assessment.
TNS for thoracic spine
SHAM COMPARATOR6 TNS treatments at home for 20min in limited power of devices in three weeks period.
Interventions
Eligibility Criteria
You may qualify if:
- Thoracic spine pain,
- years old
You may not qualify if:
- Inflammatory spine disease,
- previous surgery on thoracic spine area,
- osteoporosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fysioteekki
Oulu, Finland
Related Publications (1)
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.
PMID: 32778081DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jani Takatalo, MD
University of Jyvaskyla
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Project expert
Study Record Dates
First Submitted
February 25, 2013
First Posted
June 24, 2013
Study Start
August 1, 2011
Primary Completion
August 1, 2017
Study Completion
August 15, 2017
Last Updated
August 21, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will share