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

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Activator IV single impulse instrument
Multiple thrust Impulse adjusting instrument
Sponsored by
Anglo-European College of Chiropractic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, chiropractic, manipulation

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anglo-European College of Chiropractic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Multiple thrust Impulse instrument

Single impulse Activator IV instrument

Arm Description

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

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

Outcomes

Primary Outcome Measures

Correction of the spinal manipulable lesion
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.

Secondary Outcome Measures

Pressure pain threshold over the spinous process
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.
Surface EMG (electromyography) of the lumbar erector spinae flexion-relaxation response
Surface electromyography will be used pre-treatment and post-treatment to determine if a change in muscle activity occurs with flexing the lumbar spine.

Full Information

First Posted
July 30, 2010
Last Updated
August 11, 2010
Sponsor
Anglo-European College of Chiropractic
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1. Study Identification

Unique Protocol Identification Number
NCT01180686
Brief Title
Comparison of a Multiple Thrust Instrument to a Single Thrust Instrument in Treating the Low Back
Acronym
AECC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
March 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Anglo-European College of Chiropractic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, chiropractic, manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multiple thrust Impulse instrument
Arm Type
Active Comparator
Arm Description
This instrument automatically delivers 12 thrusts at the same intensity over the joint involved.
Arm Title
Single impulse Activator IV instrument
Arm Type
Active Comparator
Arm Description
This is a manual spring loaded device that delivers one thrust to the joint involved
Intervention Type
Device
Intervention Name(s)
Activator IV single impulse instrument
Other Intervention Name(s)
Activator IV instrument
Intervention Description
This is a manually operated device that delivers a single thrust into the joint involved.
Intervention Type
Device
Intervention Name(s)
Multiple thrust Impulse adjusting instrument
Other Intervention Name(s)
Impulse adjusting instrument
Intervention Description
A device used for delivering 12 thrusts to the involved joint of the lumbar spine.
Primary Outcome Measure Information:
Title
Correction of the spinal manipulable lesion
Description
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.
Time Frame
An average of 5 minutes from the the end of first treatment
Secondary Outcome Measure Information:
Title
Pressure pain threshold over the spinous process
Description
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.
Time Frame
An average of 5 minutes from the end of the first treatment
Title
Surface EMG (electromyography) of the lumbar erector spinae flexion-relaxation response
Description
Surface electromyography will be used pre-treatment and post-treatment to determine if a change in muscle activity occurs with flexing the lumbar spine.
Time Frame
An average of 5 minutes from the end of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hugh Gemmell, DC, EdD
Phone
44202436200
Ext
268
Email
hgemmell@aecc.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugh Gemmell, DC, EdD
Organizational Affiliation
Anglo-European College of Chiropractic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anglo-European College of Chiropractic
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH5 2DF
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugh Gemmell, DC, EdD
Email
hgemmell@aecc.ac.uk
First Name & Middle Initial & Last Name & Degree
Hugh Gemmell, DC, EdD

12. IPD Sharing Statement

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

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