A Study of a Potential Mechanisms of Spinal Manipulation in the Treatment of Low Back Pain

Low Back Pain Clinical Trial

Official title:

Immediate Effect of Physical Interventions for Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922220
• Other study ID #: 343-2004
• Status: Completed
• Phase: Phase 1
• First received: June 15, 2009
• Last updated: December 21, 2011
• Start date: October 2004
• Est. completion date: November 2008

Study information

• Verified date: June 2009
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• stationary bike
Participants rode a stationary bike for five minutes
• lumbar extension exercise
Participants performed four sets of fifteen lumbar extension exercises over fifteen minutes
• spinal manipulative therapy
participants received spinal manipulative therapy to the low back

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (2)

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/p — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale		Prior to and immediately following assigned intervention	No