Central Mechanisms of Intervention for Low Back Pain

University of Florida

Status: Completed

Conditions: Low Back Pain

Treatments: Other: Static Touch; Other: Spinal Manipulation; Other: Spinal Mobilization

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01406847

IRB201602462-N

439-2010 (Other Identifier)

1R01AT006334-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 159 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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159 participants in 3 patient groups

Spinal Manipulation

Experimental group

Description:

High-velocity manual technique applied to the pelvis with the participant in supine

Treatment:

Other: Spinal Manipulation

Static Touch

Sham Comparator group

Description:

Practitioner hands are placed on the lumbar spine with the participant in prone.

Treatment:

Other: Static Touch

Spinal Mobilization

Active Comparator group

Description:

Oscillation of the third lumbar level performed with the participant in prone

Treatment:

Other: Spinal Mobilization