Duration of Spinal Manipulation Effects as Influenced by Orthotics
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Quadruple Visual Analog Pain Scale
Study Overview
Brief Summary
Purpose of study: To assess the effects of wearing custom orthotics as opposed to placebo foot inserts on the duration of chiropractic correction of spinal fixations and muscle imbalances using applied kinesiology techniques.
Detailed Description
Participants with chronic lower back pain of greater than one month duration will be randomized to receive custom foot orthotics or placebo flat inserts. Both groups will receive chiropractic treatment 5 times over the course of 4 weeks following receipt of orthotics. Subjects and treating doctor will be blind to the insert type. Patients will report present, average, best and worst pain at each visit, and complete a Roland-Morris questionnaire. Secondary outcome measures will be number of fixated vertebral levels identified by motion palpation and challenge and number of muscles testing grade 4 and below from a list of 5 muscles to be tested bilaterally before and after each treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Current low back pain episode present for one month or more
- •No change in the past month in prescription medications affecting musculoskeletal pain
- •Able to speak and understand English adequately to complete study forms
- •Score on Roland-Morris questionnaire of 7.5 or higher or
- •Average score on Chiropractic pain Index (Now, Average, and Worst scales from the Quadruple VAS pain scale) of 4 or higher.
Exclusion Criteria
- •Use of foot orthotics within the past 12 months
- •Previous lumbar spine surgery
- •Ongoing treatment for lower back pain by other health care providers other than stable prescription medications affecting musculoskeletal pain.
- •Clinically significant chronic inflammatory spinal arthritis
- •Severe osteoporosis for which spinal manipulation is contraindicated
- •Spinal pathology or fracture
- •Progressive neurologic deficits due to nerve root or spinal cord compression, including symptoms/signs of cauda equina syndrome
- •History of bleeding disorder
- •Known arterial aneurysm
- •Pending/current litigation pertaining to back pain, including workers compensation claims
- •Current pregnancy
- •Lack of means of contacting which might preclude successful completion of study requirements
- •Does not speak , read or understand English to an extent which would affect the subject's capacity to participate in informed consent
Arms & Interventions
Intervention, Custom Orthotics
Wearing custom foot orthotics
Intervention: foot orthotics (Device)
Sham Foot Orthotic
Wearing sham or flat shoe insoles
Intervention: Sham foot orthotic (Device)
Outcomes
Primary Outcomes
Quadruple Visual Analog Pain Scale
Time Frame: Six weeks
Pain present, best worst and average on a scale of 0 to 10, with 10 being the worst imaginable.
Roland-Morris Questionnaire
Time Frame: Six weeks
Questionnaire listing activities of daily living, impacted by low back pain.
Secondary Outcomes
- Number of fixated vertebral levels(Six weeks)
- Number of tested muscles grade 4 and below(Six weeks)