Central Mechanisms of Intervention for Low Back Pain

Low Back Pain Clinical Trial

Official title:

Central Mechanisms of Body Based Intervention for Musculoskeletal Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406847
• Other study ID #: IRB201602462-N
• Secondary ID: 1R01AT006334-014
• Status: Completed
• Phase: N/A
• First received: July 26, 2011
• Last updated: April 4, 2018
• Start date: August 2012
• Est. completion date: May 1, 2017

Study information

• Verified date: April 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Body-based interventions have consistently shown clinical effectiveness in patients with back pain. The primary objective for this study is to compare the effect of body-based interventions commonly used in the management of low back pain on behavioral and cortical measures of pain sensitivity and central sensitization of pain. Participants will be randomly assigned to receive one of the interventions or be in a control group. The central hypothesis for this proposal is that spinal manipulation, a specific form of body-based intervention, inhibits central sensitization of pain normalizing pain sensitivity more rapidly than other interventions. The completion of the proposed study will elucidate underpinning mechanisms of body-based interventions. Identification of these mechanisms will improve the clinical application and utilization of these interventions in the management of musculoskeletal pain conditions, especially back pain.

Description:

170 participants will be randomly assigned to receive one of the interventions or be in a control group. The investigators will use of a model of experimentally induced low back pain to investigate the effects of manipulative and body-based interventions in acute onset low back pain without some of the clinical confounds. The investigators will collect fMRI and psychophysical data about pain sensitivity before and after the induction of pain, and before and after interventions for that pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• aged 18 to 40 years

• able to read and understand spoken English

Exclusion Criteria:

• Previous participation in a conditioning program specific to trunk extensors in the past 6 months

• Any report of back or leg pain in the past 3 months

• Any chronic medical conditions that may affect pain perception (e.g., diabetes, high blood pressure, fibromyalgia, headaches), kidney dysfunction, muscle damage, or major psychiatric disorder

• History of previous injury including surgery to the lumbar spine, renal malfunction, cardiac condition, high blood pressure, osteoporosis, or liver dysfunction

• Consumption of any drugs (e.g., caffeine, alcohol, theophyline, tranquilizers, antidepressants) that may affect pain perception or hydration status from 24 hr. before participation until completion of the investigation

• Performance of any intervention for symptoms induced by exercise and before the termination of their participation or the protocol

• Recent illness

• Any contraindication to MRI e.g.: pacemakers, metal implants which are not MRI compatible (e.g. aneurysm clip), pregnancy and severe claustrophobia.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Spinal Manipulation
High velocity low amplitude joint-biased intervention
• Spinal Mobilization
Low velocity, large amplitude oscillating joint biased technique
• Static Touch
The investigators maintains hand contact with both hands over the lumbar area of the participant

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate change in temporal sensory summation	We will use both behavioral (ratings) and cortical (using fMRI) measures of temporal sensory summation.	10 minutes post-intervention
Primary	Change in temporal sensory summation	The change temporal sensory summation (determined using quantitative sensory testing and fMRI) will be calculated from pre-intervention to 48 hours post-intervention	48 hours post-intervention
Secondary	Change in Physical Impairment Index	Physical Impairment Index is a group of tests including trunk and limb range of motion, muscle tenderness and abdominal muscle performance	48 hours post-intervention