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Trial record 1 of 1 for:    thoracic spine | Finland
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Thoracic Spine Manipulation for Patients With Thoracic Spine Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01884818
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : August 21, 2017
Information provided by (Responsible Party):
Jtakatalo, University of Jyvaskyla

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.

Condition or disease Intervention/treatment Phase
Pain Other: Manipulation vs. TNS thoracic pain Not Applicable

Detailed Description:
Outcome measures are intensity of pain (VAS, Roland-Morris questionnaire) thoracic mobility (measured with computer, tape measurements, inclinometer and manually).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Manipulation for Thoracic Spine Pain and Mobility, and Reliability of Used Mobility Measurements.
Study Start Date : August 2011
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : August 15, 2017

Arm Intervention/treatment
Experimental: Manipulation
Subjects will receive 6 manipulation treatments within 3 weeks period. The manipulated segments are determined individually in baseline assessment.
Other: Manipulation vs. TNS thoracic pain
Sham Comparator: TNS for thoracic spine
6 TNS treatments at home for 20min in limited power of devices in three weeks period.
Other: Manipulation vs. TNS thoracic pain

Primary Outcome Measures :
  1. Thoracic spine pain (Visual analogue scale) [ Time Frame: up to 49 week follow-up ]

Secondary Outcome Measures :
  1. Thoracic spine mobility (computer controllod spine PA measurement, tape measurements, inclinometer) [ Time Frame: Baseline, after treatment, 3, 8, and 49 week follow-up ]

Other Outcome Measures:
  1. Work absent [ Time Frame: Baseline, after treatment, 3, 8 and 49 week follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Thoracic spine pain,
  • 18-55 years old

Exclusion Criteria:

  • Inflammatory spine disease,
  • previous surgery on thoracic spine area,
  • osteoporosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01884818

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Oulu, Finland
Sponsors and Collaborators
University of Jyvaskyla
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Principal Investigator: Jani Takatalo, MD University of Jyvaskyla
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jtakatalo, Project expert, University of Jyvaskyla Identifier: NCT01884818    
Other Study ID Numbers: Thoracic
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Jtakatalo, University of Jyvaskyla:
Thoracic spine, pain, manipulation