CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Spinal mechanical manipulation intervention +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01469533
NCT01469533N/ACompleted

Changes in Pressure Pain Thresholds and Basal Electromyographic Activities Following Spinal Mechanical Manipulation in Asymptomatic Subjects

RenJi Hospital·interventional·Posted Nov 10, 2011·Updated Nov 10, 2011

In Brief

A clinical study evaluating Spinal mechanical manipulation intervention and Sham manipulation intervention for Pain. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this study is to investigate if the application of spinal mechanical manipulation on low back region resulted in changes in pressure pain thresholds (PPT) in asymptomatic subjects and the extent of the hypoalgesia; whether it is local, regional or systemic. Simultaneously, the investigators are to further explore the phenomenon of reduced sEMG activity after spinal mechanical manipulation to better understand the immediate effects of mechanical manipulation on low back region.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2011
Enrollment StartJul 1, 2011
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.6 years ago

Interventions

Spinal mechanical manipulation interventionother

Subjects in experimental group are assessed through use of the Activator Methods (AM) assessment protocol. Spinal adjustment of the indicated pelvis, sacrum and lumbar spine is performed through the use of spinal mechanical manipulation. In this study leg length analysis only uses Position #1 and Position #2. Mechanical manipulation is delivered with the Activator Ⅳ Adjusting Instrument (AAI Ⅳ; Activator Methods International, Ltd, Phoenix, AZ) set in the maximal force setting 4, as it is used in routine clinical practice. The Activator Ⅳ delivers a very short duration (\<5 ms) force-time impulse with a peak force magnitude of approximately 176N.

Sham manipulation interventionother

Subjects in the control group receive a protocol identical to that described above, with the following exception: a sham mechanical thrust is delivered during the AM protocol. The sham procedure is accomplished by setting the expansion control knob on the Activator Ⅱ to the zero (off) position. The expansion control is used to adjust the spring compression and thus the amount of excursion of the instruments' stylus. In the zero position, no excursion of the stylus occurs, although the same clicking sound that the instrument produces during normal use is heard after manual activation of the mechanical trigger.