Duration of Spinal Manipulation Effects as Influenced by Orthotics

Logan College of Chiropractic

Status and phase: Completed; Phase 2; Phase 1

Conditions: Low Back Pain

Treatments: Device: Sham foot orthotic; Device: foot orthotics

Study type: Interventional

Funder types: Other

Identifiers

NCT01704807

LCC-12-RD0519110317

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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41 participants in 2 patient groups

Intervention, Custom Orthotics

Active Comparator group

Description:

Wearing custom foot orthotics

Treatment:

Device: foot orthotics

Sham Foot Orthotic

Sham Comparator group

Description:

Wearing sham or flat shoe insoles

Treatment:

Device: Sham foot orthotic