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NCT01884818 Clinical Trial

Thoracic Spine Manipulation for Patients With Thoracic Spine Pain

Pain Clinical Trial

Official title:
The Effect of Manipulation for Thoracic Spine Pain and Mobility, and Reliability of Used Mobility Measurements.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01884818
Other study ID # Thoracic
Secondary ID
Status Completed
Phase N/A
First received February 25, 2013
Last updated August 16, 2017
Start date August 2011
Est. completion date August 15, 2017

Study information
Verified date August 2017
Source University of Jyvaskyla
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date August 15, 2017
Est. primary completion date August 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Thoracic spine pain,

- 18-55 years old

Exclusion Criteria:

- Inflammatory spine disease,

- previous surgery on thoracic spine area,

- osteoporosis

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Manipulation vs. TNS thoracic pain

Locations
Country Name City State
Finland Fysioteekki Oulu

Sponsors (1)
Lead Sponsor Collaborator
University of Jyvaskyla

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Other Work absent Baseline, after treatment, 3, 8 and 49 week follow-up
Primary Thoracic spine pain (Visual analogue scale) up to 49 week follow-up
Secondary Thoracic spine mobility (computer controllod spine PA measurement, tape measurements, inclinometer) Baseline, after treatment, 3, 8, and 49 week follow-up
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