measurINg forceS durInG cHiropractic Treatment

NCT02409797 | Completed DMC

• 1 other identifier: INSIGHT-2015V164
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain Visual Analog Scale (VAS)

  Baseline and 2 weeks

Study Arms (1)

Flexion-Distraction spinal manipulation

EXPERIMENTAL

Participants will receive Flexion-Distraction treatment from a licensed doctor of chiropractic. During the procedure the participant lies prone on a specially designed treatment table. The table is equipped with a movable lower body section, which can be directed by the study doctor to lower the participants legs, move them from side to side, or in a traction motion. Table movements can occur in combination with other motions, depending on the diagnosis and characteristics specific to the participant's condition. During this procedure, the doctor will also touch the lower or upper part of the participants back or neck with their hands to direct treatment toward specific spinal regions.

Other: Flexion-Distraction (non-thrust) spinal manipulation

Interventions

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.

Flexion-Distraction spinal manipulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Palmer College of Chiropractic: lead

Study Sites (1)

Palmer Center for Chiropractic Research

Davenport, Iowa, 52803, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Robert D Vining, DC

  Palmer Center for Chiropractic Research (PCCR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: April 7, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 30, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)