Clinical trial NCT01704807: Duration of Spinal Manipulation Effects as Influenced by Orthotics
Official title: Duration of Spinal Manipulation Effects as Influenced by Orthotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Low Back Pain
Keywords: Low Back Pain
Chronic
Orthotic Device
Applied Kinesiology
Manual Muscle Testing
Chiropractic
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quadruple Visual Analog Pain Scale
timeFrame: Six weeks
measure: Roland-Morris Questionnaire
timeFrame: Six weeks
Secondary outcomes:
measure: Number of fixated vertebral levels
timeFrame: Six weeks
measure: Number of tested muscles grade 4 and below
timeFrame: Six weeks
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan College of Chiropractic/University Programs
state: Missouri
Study officials:
affiliation: Logan College of Chiropractic/University Programs
name: Katharine Conable, DC
role: PRINCIPAL_INVESTIGATOR
affiliation: International College of Applied Kinesiology
name: Anthony Rosner, PhD
role: PRINCIPAL_INVESTIGATOR
References: