Thoracic Spine Manipulation for Patients With Thoracic Spine Pain

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: Manipulation vs. TNS thoracic pain

• Registration Number: NCT01884818
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-02-25
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-24
• Status Verified: 2017-08
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-15
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Thoracic spine pain,
• 18-55 years old

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manipulation	Manipulation vs. TNS thoracic pain	Subjects will receive 6 manipulation treatments within 3 weeks period. The manipulated segments are determined individually in baseline assessment.
TNS for thoracic spine	Manipulation vs. TNS thoracic pain	6 TNS treatments at home for 20min in limited power of devices in three weeks period.

Primary Outcome Measures

Name	Time	Method
Thoracic spine pain (Visual analogue scale)	up to 49 week follow-up

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fysioteekki; 🇫🇮 Oulu, Finland