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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01180686

Acronym

AECC

Enrollment

Registered

2010-08-12

Start date

2010-09-30

Completion date

2011-03-31

Last updated

2010-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

low back pain, chiropractic, manipulation

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.

Interventions

DEVICEActivator IV single impulse instrument

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

DEVICEMultiple thrust Impulse adjusting instrument

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Correction of the spinal manipulable lesion	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.

Secondary

Measure	Time frame	Description
Pressure pain threshold over the spinous process	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.
Surface EMG (electromyography) of the lumbar erector spinae flexion-relaxation response	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.

Countries

United Kingdom

Contacts

Primary ContactHugh Gemmell, DC, EdD

hgemmell@aecc.ac.uk44202436200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026