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

August 11, 2010 updated by: Anglo-European College of Chiropractic

Comparative Effectiveness of the Multiple Thrust Impulse Instrument and the Activator IV Single Thrust Instrument in Correcting a Lumbar Spinal Manipulable Lesion and Improving Lumbar Erector Spinae Flexion-relaxation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

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

  • United Kingdom
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH5 2DF
        • Anglo-European College of Chiropractic

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 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Multiple thrust Impulse instrument
This instrument automatically delivers 12 thrusts at the same intensity over the joint involved.
Device: Multiple thrust Impulse adjusting instrument
A device used for delivering 12 thrusts to the involved joint of the lumbar spine.
Other Names:
  • Impulse adjusting instrument
ACTIVE_COMPARATOR: Single impulse Activator IV instrument
This is a manual spring loaded device that delivers one thrust to the joint involved
Device: Activator IV single impulse instrument
This is a manually operated device that delivers a single thrust into the joint involved.
Other Names:
  • Activator IV instrument

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correction of the spinal manipulable lesion
Time Frame: An average of 5 minutes from the the end of first treatment
Tests used to determine the presence of a spinal manipulable lesion (a lesion in the spine requiring manipulation) will be used post-treatment to determine of correction has been achieved.
An average of 5 minutes from the the end of first treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure pain threshold over the spinous process
Time Frame: An average of 5 minutes from the end of the first treatment
An instrument used to measure pressure in kilograms is placed over the spinous process of the vertebra involved and the level of pressure is recorded when the sensation of pressure changes to pain.
An average of 5 minutes from the end of the first treatment
Surface EMG (electromyography) of the lumbar erector spinae flexion-relaxation response
Time Frame: An average of 5 minutes from the end of treatment.
Surface electromyography will be used pre-treatment and post-treatment to determine if a change in muscle activity occurs with flexing the lumbar spine.
An average of 5 minutes from the end of treatment.

Collaborators and Investigators

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

Sponsor

Anglo-European College of Chiropractic

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

September 1, 2010

Primary Completion (ANTICIPATED)

March 1, 2011

Study Completion (ANTICIPATED)

March 1, 2011

Study Registration Dates

First Submitted

July 30, 2010

First Submitted That Met QC Criteria

August 11, 2010

First Posted (ESTIMATE)

August 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 12, 2010

Last Update Submitted That Met QC Criteria

August 11, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AECC 30610
  • AECC30610 (OTHER: Anglo-European College of Chiropractic)

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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