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| ID | Type | Description | Link |
|---|---|---|---|
| 3R01AT006334-02S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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This is study testing the feasibility of collecting neurophysiological measures of outcome related to body-based interventions for low back pain. The investigators will collect fMRI and psychophysical data about pain sensitivity before and after the interventions. Participants will be randomly assigned to either spinal manipulation or therapeutic touch groups. Participants will attend two practice sessions prior to the first data collection. There will be two follow-up assessments.
Participants will be enrolled from VA pain clinical at the North Florida/South George VA Medical Center.
The investigators will collect functional magnetic resonance imaging data of resting state and pain-related events (i.i. during thermal pain sensitivity testing, as well as psychophysical data to determine pain sensitivity. Pain sensitivity will be measured using thermal and mechanical stimuli. These data will be collected before and after the interventions, in addition to two follow-up sessions after intervention.
In addition, clinical measures of pain intensity in the low back, as well as trunk range of motion and strength will also be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal manipulation | Experimental | Participants will receive a lumbar SMT technique previously described in the literature and commonly utilized for the treatment of low back pain . The SMT will be performed four times (two times on each side) in a 5-minute period. In addition, the following will be performed: Functional MRI (fMRI), Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment. |
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| Therapeutic touch | Sham Comparator | Participants in this group will lie prone. The therapist will place both hands in contact with the participants' pelvis across the top of the posterior aspect of the sacrum and ilia and apply a downward force to keep the pelvis in contact with the table. This group accounts for effects of time and personal contact. The amount of "hands-on" contact will be equivalent between groups. Both groups will be given the same verbal instructions regarding the techniques performed. In addition, the following will be performed: Functional MRI (fMRI), Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal manipulation | Procedure | Participants will receive a lumbar SMT technique previously described in the literature and commonly utilized for the treatment of low back pain . The SMT will be performed four times (two times on each side) in a 5-minute period. In addition, the following will be performed: Functional MRI, Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment. |
| Measure | Description | Time Frame |
|---|---|---|
| fMRI during testing of pain changes from approximately Day 3 and Day 5 | Change from approximately Day 3 and Day 5 | |
| fMRI during quite rest changes from approximately Day 3 and Day 5 | Change from approximately Day 3 and Day 5 | |
| Pain Sensitivity Testing changes from Day 3, Day 4 and Day 5 | This measure thermal threshold and tolerance using continuous heat stimulus delivered to the participants' dominant arm. The stimulus will start at 35°C and will be increased at a rate of 0.5°C with participants terminating the stimulus when the temperature reached pain threshold ("when the sensation first transitions from heat to pain") and tolerance ("when the sensation becomes so strong you want to remove it from your skin"). Threshold and tolerance measures will also be collected using mechanical pressure applied using a Fischer Dolorimeter. During Dolorimeter testing, force is slowly increased until the subject indicates that the sensation changes from pressure to pain. | Change from Day 3, Day 4 and Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Pain visual analog scale is a 10cm long line. The line is anchored at one end with 'none' or 'not bad at all' and at the other with 'worst imaginable.' Participants are asked to rate their pain at rest by placing a mark along the 10cm line. Participants will also rate pain during active trunk range of motion using the same scale. | Change from Day 3, Day 4 and Day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark D Bishop, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610-0154 | United States |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D020393 | Manipulation, Spinal |
| D019124 | Therapeutic Touch |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Therapeutic touch | Procedure | Participants in this group will lie prone. The therapist will place both hands in contact with the participants' pelvis across the top of the posterior aspect of the sacrum and ilia and apply a downward force to keep the pelvis in contact with the table. This group accounts for effects of time and personal contact. The amount of "hands-on" contact will be equivalent between groups. Both groups will be given the same verbal instructions regarding the techniques performed. In addition, the following will be performed: Functional MRI, Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment. |
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| fMRI | Procedure | Both groups will receive an fMRI. |
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| Pain Sensitivity Testing | Behavioral | Both groups will receive an Pain Sensitivity Testing |
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| Questionnaires | Other | Both groups will receive Questionnaires |
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| Physical Impairment | Behavioral | Both groups will receive testing on physical impairment. |
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| McGill Pain Questionnaire-2 | This is 22-item questionnaire that asks participants to describe the intensity of varies qualities of the pain that he or she is experiencing; for example, throbbing or itching. | Change from Day 3, Day 4 and Day 5 |
| Physical Impairment | A physical impairment scale consists of 7 different examination procedures that assess lumbar and hip range of motion, muscle performance of trunk musculature, and response to palpation. Scores is 0 - 8, Range is 0 is no impairment and 8 is completely impaired. | Change from Day 3, Day 4 and Day 5 |
| Oswestry Disability Questionnaire (ODQ) | The ODQ has a range of 0 (no disability due to back pain) to 100 (completely disabled due to back pain), so higher scores indicate higher disability from LBP. | Change from Day 3, Day 4 and Day 5 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D026441 |
| Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D026443 | Spiritual Therapies |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |