Skip to content

Central Mechanisms of Intervention for Low Back Pain

Central Mechanisms of Body Based Intervention for Musculoskeletal Low Back Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01406847
Enrollment
159
Registered
2011-08-01
Start date
2012-08-31
Completion date
2017-05-01
Last updated
2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Spinal Manipulation, Body-based intervention, Experimental pain

Brief 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.

Detailed 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.

Interventions

OTHERSpinal Manipulation

High velocity low amplitude joint-biased intervention

Low velocity, large amplitude oscillating joint biased technique

OTHERStatic Touch

The investigators maintains hand contact with both hands over the lumbar area of the participant

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Immediate change in temporal sensory summation10 minutes post-interventionWe will use both behavioral (ratings) and cortical (using fMRI) measures of temporal sensory summation.
Change in temporal sensory summation48 hours post-interventionThe change temporal sensory summation (determined using quantitative sensory testing and fMRI) will be calculated from pre-intervention to 48 hours post-intervention

Secondary

MeasureTime frameDescription
Change in Physical Impairment Index48 hours post-interventionPhysical Impairment Index is a group of tests including trunk and limb range of motion, muscle tenderness and abdominal muscle performance

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026