Thoracic Spine Manipulation for Patients With Thoracic Spine Pain

August 16, 2017 updated by: Jtakatalo, University of Jyvaskyla

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland
        • Fysioteekki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Thoracic spine pain,
  • 18-55 years old

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Thoracic spine pain (Visual analogue scale)
Time Frame: up to 49 week follow-up
up to 49 week follow-up

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Work absent
Time Frame: Baseline, after treatment, 3, 8 and 49 week follow-up
Baseline, after treatment, 3, 8 and 49 week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jyvaskyla

Investigators

  • Principal Investigator: Jani Takatalo, MD, University of Jyväskylä

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 15, 2017

Study Registration Dates

First Submitted

February 25, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (Estimate)

June 24, 2013

Study Record Updates

Last Update Posted (Actual)

August 21, 2017

Last Update Submitted That Met QC Criteria

August 16, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Thoracic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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