measurINg forceS durInG cHiropractic Treatment (INSIGHT): A Single-Arm Clinical Case Series
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Traction forces
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Able to demonstrate the necessary abilities (English language, literacy) needed to provide informed consent without the assistance of another person (e.g., a proxy, spouse, family member or other support person)
- •Self-reported low back pain (acute, subacute or chronic) at the time of examination and enrollment
Exclusion Criteria
- •Weight > 300lbs
- •Spinal Pathology or conditions contraindicating study procedures or compromising participant safety
- •Inflammatory arthropathy involving the spine (e.g. Ankylosing spondylitis, Rheumatoid arthritis)
- •Spinal fracture in the past 6 months
- •Other conditions requiring referral (e.g. self-reporting alcohol/substance dependence or abuse, unstable spinal segments, and cauda equina syndrome)
- •Pregnant or planning to become pregnant within the next 5 weeks
- •Unable to tolerate study procedures safely
- •Altered Mental Capacity
- •Sensitivity to adhesives used in the study
- •Uncontrolled hypertension
- •Co-morbidity requiring simultaneous clinical management that compromises ability to deliver study procedures or assess the participant's heath status or poses as a scheduling burden
- •Retention of legal advice or seeking a health-related insurance claim
- •Compliance concerns (e.g. scheduling conflicts, moving from the quad city area, unwilling to undergo required study procedures or receive treatment from study doctor(s))
- •Quebec Task Force Classification of 10 or 11: (chronic pain syndrome, visceral/infectious source of LBP)
Outcomes
Primary Outcomes
Traction forces
Time Frame: Baseline and 2 weeks
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.
Secondary Outcomes
- Pain Visual Analog Scale (VAS)(Baseline and 2 weeks)