Comparison of a Multiple Thrust Instrument to a Single Thrust Instrument in Treating the Low Back

NCT ID: NCT01180686

Last Updated: 2010-08-12

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

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-03-31

Brief Summary

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The purposes of this study are to determine if there is a difference between two treatment methods of spine joints that are not moving as they should as determined by tenderness over the spine and activity of the muscles along side the spine with movement.

The hypothesis is that there will be no difference between the two types of treatment.

Detailed Description

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Two specialised instruments used for treating manipulable lesions of the spine will be compared using muscle relaxation response of the erector spinae muscles and correction of the spinal manipulable lesion.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Multiple thrust Impulse instrument

This instrument automatically delivers 12 thrusts at the same intensity over the joint involved.

Group Type ACTIVE_COMPARATOR

Multiple thrust Impulse adjusting instrument

Intervention Type DEVICE

A device used for delivering 12 thrusts to the involved joint of the lumbar spine.

Single impulse Activator IV instrument

This is a manual spring loaded device that delivers one thrust to the joint involved

Group Type ACTIVE_COMPARATOR

Activator IV single impulse instrument

Intervention Type DEVICE

This is a manually operated device that delivers a single thrust into the joint involved.

Interventions

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Activator IV single impulse instrument

This is a manually operated device that delivers a single thrust into the joint involved.

Intervention Type DEVICE

Multiple thrust Impulse adjusting instrument

A device used for delivering 12 thrusts to the involved joint of the lumbar spine.

Intervention Type DEVICE

Other Intervention Names

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Activator IV instrument Impulse adjusting instrument

Eligibility Criteria

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Inclusion Criteria

* Between 18-64 years of age
* Fluent in English
* With non-specific low back pain
* No lumbar manipulation within the prior 24 hours
* Not involved in strenuous back exercise on the day preceding the study
* Have not taken pain medication for two days prior to the study

Exclusion Criteria

* Absolute contraindications to manipulation
* Specific causes for the low back pain
* Involved in or pending litigation for low back pain
* Lumbar related leg pain
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anglo-European College of Chiropractic

OTHER

Sponsor Role lead

Responsible Party

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Anglo-European College of Chiropractic

Principal Investigators

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Hugh Gemmell, DC, EdD

Role: PRINCIPAL_INVESTIGATOR

Anglo-European College of Chiropractic

Locations

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Anglo-European College of Chiropractic

Bournemouth, Dorset, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Hugh Gemmell, DC, EdD

Role: CONTACT

44202436200 ext. 268

Facility Contacts

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Hugh Gemmell, DC, EdD

Role: primary

Other Identifiers

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AECC30610

Identifier Type: OTHER

Identifier Source: secondary_id

AECC 30610

Identifier Type: -

Identifier Source: org_study_id

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