Clinical trial NCT02409797: measurINg forceS durInG cHiropractic Treatment
Official title: measurINg forceS durInG cHiropractic Treatment (INSIGHT): A Single-Arm Clinical Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Palmer College of Chiropractic
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Traction forces
timeFrame: Baseline and 2 weeks
Secondary outcomes:
measure: Pain Visual Analog Scale (VAS)
timeFrame: Baseline and 2 weeks
Other outcomes:
Locations:
city: Davenport
country: United States
facility: Palmer Center for Chiropractic Research
state: Iowa
Study officials:
affiliation: Palmer Center for Chiropractic Research (PCCR)
name: Robert D Vining, DC
role: PRINCIPAL_INVESTIGATOR
References: