Thoracic Spine Manipulation for Patients With Thoracic Spine Pain

NCT ID: NCT01884818

Last Updated: 2017-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2017-08-15

Brief Summary

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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

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

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Manipulation

Subjects will receive 6 manipulation treatments within 3 weeks period. The manipulated segments are determined individually in baseline assessment.

Group Type EXPERIMENTAL

Manipulation vs. TNS thoracic pain

Intervention Type OTHER

TNS for thoracic spine

6 TNS treatments at home for 20min in limited power of devices in three weeks period.

Group Type SHAM_COMPARATOR

Manipulation vs. TNS thoracic pain

Intervention Type OTHER

Interventions

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Manipulation vs. TNS thoracic pain

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Thoracic spine pain,
* 18-55 years old

Exclusion Criteria

* Inflammatory spine disease,
* previous surgery on thoracic spine area,
* osteoporosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Jyvaskyla

OTHER

Sponsor Role lead

Responsible Party

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Jtakatalo

Project expert

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jani Takatalo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Jyvaskyla

Locations

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Fysioteekki

Oulu, , Finland

Site Status

Countries

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Finland

References

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Takatalo J, Ylinen J, Pienimaki T, Hakkinen A. Intra- and inter-rater reliability of thoracic spine mobility and posture assessments in subjects with thoracic spine pain. BMC Musculoskelet Disord. 2020 Aug 10;21(1):529. doi: 10.1186/s12891-020-03551-4.

Reference Type DERIVED
PMID: 32778081 (View on PubMed)

Other Identifiers

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Thoracic

Identifier Type: -

Identifier Source: org_study_id

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