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Completed

NCT Number: NCT02409797

measurINg forceS durInG cHiropractic Treatment

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palmer Center for Chiropractic Research

Davenport, Iowa, 52803, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Flexion-Distraction (non-thrust) spinal manipulation

Other

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.

Primary outcomes

  1. 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

  1. Pain Visual Analog Scale (VAS)

    Time frame: Baseline and 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

Palmer College of Chiropractic

Other

Registry information

Official study title

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

Acronym: INSIGHT

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 7, 2015
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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