measurINg forceS durInG cHiropractic Treatment

Low Back Pain Clinical Trial

— INSIGHT  

Official title:

measurINg forceS durInG cHiropractic Treatment (INSIGHT): A Single-Arm Clinical Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409797
• Other study ID #: INSIGHT-2015V164
• Status: Completed
• Phase: N/A
• First received: March 12, 2015
• Last updated: March 28, 2017
• Start date: March 2015
• Est. completion date: July 2015

Study information

• Verified date: March 2017
• Source: Palmer College of Chiropractic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Flexion-Distraction (non-thrust) spinal manipulation
Enrolled participants will receive chiropractic care over a 2-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach and treatment frequency based upon a participant's clinical presentation. If provided, treatments will include low-velocity (non-thrust) spinal manipulation using the Flexion-Distraction procedure. Recommendations for exercise, lifestyle modifications, or other therapies may also be provided.

Locations

Country	Name	City	State
United States	Palmer Center for Chiropractic Research	Davenport	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Palmer College of Chiropractic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Traction forces	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.	Baseline and 2 weeks
Secondary	Pain Visual Analog Scale (VAS)	The Visual Analog Scale (VAS) will be used to assess the participant's current back pain level and their average back pain levels over the past 24hrs and week. Participants will be asked to rate their level of pain on a 100 millimeter continuum horizontal scale with no pain and worst imaginable pain anchors.	Baseline and 2 weeks