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OpenTrials
Completed

NCT Number: NCT01884818

Thoracic Spine Manipulation for Patients With Thoracic Spine Pain

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fysioteekki

Oulu, Finland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Thoracic spine pain,
  • 18-55 years old

Exclusion criteria

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

Treatment and study plan

Manipulation vs. TNS thoracic pain

Other

Primary outcomes

  1. Thoracic spine pain (Visual analogue scale)

    Time frame: up to 49 week follow-up

Secondary outcomes

  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 outcomes

  1. Work absent

    Time frame: Baseline, after treatment, 3, 8 and 49 week follow-up

Sponsors and collaborators

Lead sponsor

University of Jyvaskyla

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jun 24, 2013
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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