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The INSIGHT pilot study will measure forces applied by a doctor of chiropractic (DC) during the delivery of a specific, manually based chiropractic treatment for participants with low back pain.
Low back pain (LBP) is a well-recognized health problem. One common manual therapy available for the treatment of LBP is spinal manipulation (SM), which can be separated into 2 categories: High-Velocity Low-Amplitude (thrust) and Low-Velocity (non-thrust) SM according to their force-delivery profiles. One commonly utilized non-thrust SM technique is the Flexion-Distraction procedure. Several studies have reported manually applied forces during thrust SM; however, the forces used during non-thrust SM, specifically those used with Flexion-Distraction treatment are still unknown. The results of this pilot study will provide preliminary information on treatment forces and sample size justification for future full-scale trials, while also ascertaining the feasibility of the study protocol and patient recruitment methods for such trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flexion-Distraction spinal manipulation | Experimental | Participants will receive Flexion-Distraction treatment from a licensed doctor of chiropractic. During the procedure the participant lies prone on a specially designed treatment table. The table is equipped with a movable lower body section, which can be directed by the study doctor to lower the participants legs, move them from side to side, or in a traction motion. Table movements can occur in combination with other motions, depending on the diagnosis and characteristics specific to the participant's condition. During this procedure, the doctor will also touch the lower or upper part of the participants back or neck with their hands to direct treatment toward specific spinal regions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexion-Distraction (non-thrust) spinal manipulation | Other | Enrolled participants will receive chiropractic care over a 2-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach and treatment frequency based upon a participant's clinical presentation. If provided, treatments will include low-velocity (non-thrust) spinal manipulation using the Flexion-Distraction procedure. Recommendations for exercise, lifestyle modifications, or other therapies may also be provided. |
| Measure | Description | Time Frame |
|---|---|---|
| Traction forces | We will measure traction forces delivered to the participant by the clinician during all study visits over a 2-week time period. Traction forces will be summarized descriptively with means and standard deviations. Primary outcomes will compare changes in traction forces between the baseline and final treatment visit at 2 weeks. | Baseline and 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Visual Analog Scale (VAS) | The Visual Analog Scale (VAS) will be used to assess the participant's current back pain level and their average back pain levels over the past 24hrs and week. Participants will be asked to rate their level of pain on a 100 millimeter continuum horizontal scale with no pain and worst imaginable pain anchors. | Baseline and 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert D Vining, DC | Palmer Center for Chiropractic Research (PCCR) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palmer Center for Chiropractic Research | Davenport | Iowa | 52803 | United States |
Feasibility/pilot study
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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 |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |