NCT00922220

Brief Summary

The purpose of this study was to determine the immediate effect of 3 common physical therapy interventions for people experiencing low back pain on the perception of thermal pain. Additionally, the investigators wished to determine the influence of psychological factors related to fear and anxiety on their findings and to determine whether the effects of the individual interventions were local (specific to the area of application) or global (influenced regions away from the area of application).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P75+ for phase_1 low-back-pain

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_1 low-back-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

October 1, 2004

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
Last Updated

December 22, 2011

Status Verified

June 1, 2009

Enrollment Period

4.1 years

First QC Date

June 15, 2009

Last Update Submit

December 21, 2011

Conditions

Low Back Pain

Keywords

low back painspinal manipulationcentral sensitizationmanual therapy

Outcome Measures

Primary Outcomes (1)

  • Numeric Rating Scale

    Prior to and immediately following assigned intervention

Study Arms (3)

stationary bike

ACTIVE COMPARATOR

Participants rode a stationary bike for five minutes

Other: stationary bike

lumbar extension exercises

ACTIVE COMPARATOR

Participants performed four sets of fifteen lumbar extension exercises over five minutes

Other: lumbar extension exercise

spinal manipulative therapy

EXPERIMENTAL

Participants received spinal manipulative therapy to the low back

Other: spinal manipulative therapy

Interventions

stationary bikeOTHER

Participants rode a stationary bike for five minutes

stationary bike
lumbar extension exerciseOTHER

Participants performed four sets of fifteen lumbar extension exercises over fifteen minutes

Also known as: press up
lumbar extension exercises
spinal manipulative therapyOTHER

participants received spinal manipulative therapy to the low back

Also known as: spinal manipulation, manual therapy
spinal manipulative therapy

Eligibility Criteria

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

You may qualify if:

  • ages eighteen to sixty
  • currently experiencing low back pain OR currently not experiencing low back pain and have not had an episode for the prior six months

You may not qualify if:

  • non-English speaking
  • systemic medical conditions (e.g. diabetes, hypertension)
  • current use of psychiatric medication
  • pregnancy
  • signs and symptoms indicative of nerve root compression (reflex change, myotomal weakness, or sensation change)
  • history of surgery to the low back

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (2)

  • George SZ, Bishop MD, Bialosky JE, Zeppieri G Jr, Robinson ME. Immediate effects of spinal manipulation on thermal pain sensitivity: an experimental study. BMC Musculoskelet Disord. 2006 Aug 15;7:68. doi: 10.1186/1471-2474-7-68.

    PMID: 16911795RESULT

  • Bialosky JE, Bishop MD, Robinson ME, Zeppieri G Jr, George SZ. Spinal manipulative therapy has an immediate effect on thermal pain sensitivity in people with low back pain: a randomized controlled trial. Phys Ther. 2009 Dec;89(12):1292-303. doi: 10.2522/ptj.20090058. Epub 2009 Oct 1.

    PMID: 19797305RESULT

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, SpinalMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitationComplementary Therapies

Study Officials

  • Steven Z George, Phd

    University of Florida Department of Physical Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 17, 2009

Study Start

October 1, 2004

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 22, 2011

Record last verified: 2009-06

Locations

US(1)