NCT01469533

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
Last Updated

November 10, 2011

Status Verified

November 1, 2011

Enrollment Period

3 months

First QC Date

November 3, 2011

Last Update Submit

November 8, 2011

Conditions

Pain

Keywords

SpineManipulationPain ThresholdElectromyography.

Outcome Measures

Primary Outcomes (1)

  • Pressure pain threshold assessment

    A mechanical pressure algometer (Wagner, Greenwich, CT) is used to measure PPT levels. Participants report to stop the pressure stimulation immediately when the sensation turnes from pressure to pain. The L5-S1 zygapophyseal is chosen as a landmark local to the manipulation. The L5 dermatome is chosen to measure the extent of any hypoalgesic response. The first dorsal interossei in the hand is selected to evaluate if there was a systemic response to the manipulation.

    within 10 minutes immediately after manipulation

Secondary Outcomes (1)

  • Basal electromyographic activity

    within 10 minutes immediately after manipulation

Study Arms (2)

experimental group

EXPERIMENTAL

The experimental group receives the real spinal mechanical manipulation.

Other: Spinal mechanical manipulation intervention

control group

SHAM COMPARATOR

The control group receives the sham-manipulation procedure.

Other: Sham manipulation intervention

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.

Also known as: Activator methods maximal setting
experimental group
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.

Also known as: Activator methods zero setting
control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • asymptomatic volunteers
  • age from 18 to 60 years

You may not qualify if:

  • aversion to manual contact
  • symptoms in the low back or lower extremities
  • previous history of spine surgery
  • receiving any manual therapy within the past 1 month before the study
  • any contraindication to manipulation
  • regular use of analgesic or anti-inflammatory drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (9)

  • Giles LG, Muller R. Chronic spinal pain: a randomized clinical trial comparing medication, acupuncture, and spinal manipulation. Spine (Phila Pa 1976). 2003 Jul 15;28(14):1490-502; discussion 1502-3. doi: 10.1097/00007632-200307150-00003.

    PMID: 12865832BACKGROUND

  • Lawrence DJ, Meeker W, Branson R, Bronfort G, Cates JR, Haas M, Haneline M, Micozzi M, Updyke W, Mootz R, Triano JJ, Hawk C. Chiropractic management of low back pain and low back-related leg complaints: a literature synthesis. J Manipulative Physiol Ther. 2008 Nov-Dec;31(9):659-74. doi: 10.1016/j.jmpt.2008.10.007.

    PMID: 19028250BACKGROUND

  • Boal RW, Gillette RG. Central neuronal plasticity, low back pain and spinal manipulative therapy. J Manipulative Physiol Ther. 2004 Jun;27(5):314-26. doi: 10.1016/j.jmpt.2004.04.005.

    PMID: 15195039BACKGROUND

  • Cramer G, Budgell B, Henderson C, Khalsa P, Pickar J. Basic science research related to chiropractic spinal adjusting: the state of the art and recommendations revisited. J Manipulative Physiol Ther. 2006 Nov-Dec;29(9):726-61. doi: 10.1016/j.jmpt.2006.09.003.

    PMID: 17142166BACKGROUND

  • Vernon H. Qualitative review of studies of manipulation-induced hypoalgesia. J Manipulative Physiol Ther. 2000 Feb;23(2):134-8. doi: 10.1016/s0161-4754(00)90084-8.

    PMID: 10714544BACKGROUND

  • de Camargo VM, Alburquerque-Sendin F, Berzin F, Stefanelli VC, de Souza DP, Fernandez-de-las-Penas C. Immediate effects on electromyographic activity and pressure pain thresholds after a cervical manipulation in mechanical neck pain: a randomized controlled trial. J Manipulative Physiol Ther. 2011 May;34(4):211-20. doi: 10.1016/j.jmpt.2011.02.002. Epub 2011 Mar 21.

    PMID: 21621722BACKGROUND

  • Fernandez-Carnero J, Fernandez-de-las-Penas C, Cleland JA. Immediate hypoalgesic and motor effects after a single cervical spine manipulation in subjects with lateral epicondylalgia. J Manipulative Physiol Ther. 2008 Nov-Dec;31(9):675-81. doi: 10.1016/j.jmpt.2008.10.005.

    PMID: 19028251BACKGROUND

  • DeVocht JW, Pickar JG, Wilder DG. Spinal manipulation alters electromyographic activity of paraspinal muscles: a descriptive study. J Manipulative Physiol Ther. 2005 Sep;28(7):465-71. doi: 10.1016/j.jmpt.2005.07.002.

    PMID: 16182019BACKGROUND

  • Fernandez-de-Las-Penas C, Alonso-Blanco C, Cleland JA, Rodriguez-Blanco C, Alburquerque-Sendin F. Changes in pressure pain thresholds over C5-C6 zygapophyseal joint after a cervicothoracic junction manipulation in healthy subjects. J Manipulative Physiol Ther. 2008 Jun;31(5):332-7. doi: 10.1016/j.jmpt.2008.04.006.

    PMID: 18558274BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Xiangrui Wang

    RenJi Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2011

First Posted

November 10, 2011

Study Start

July 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 10, 2011

Record last verified: 2011-11

Locations

CN(1)