Patient Response to Spinal Manipulation - Pilot Study

NCT01562756 | Completed Results

• 2 other identifiers: PRiSM PilotU19AT004663
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research will conduct a pilot study for the purposes of testing equipment, finalizing data collection protocol, and training study personnel before conducting the full-scale trial.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Number of Participants Who Were Recruited, Consented, Enrolled, and Completed the Study

  Feasibility was measured by the numbers of participants: recruited, consented, enrolled, and retained. This pilot study allowed for testing of equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial.

  Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits

• Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Study Duration.

  Feasibility was measured by the study duration from study launch to collection of final study outcomes. This pilot study allowed for testing of equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial.

  Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits

Study Arms (1)

HVLA-SM

EXPERIMENTAL

High velocity, low amplitude lumbo-pelvic manipulation

Other: HVLA-SM

Interventions

HVLA-SM OTHER

High velocity, low amplitude spinal manipulation

HVLA-SM

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-65
• Signed informed consent document
• Chronic (12+ weeks) low back pain (LBP)
• Average pain within past 24 hours ≥ 2/10 at phone screen, baseline visit 1, and baseline visit 2

You may not qualify if:

• Compliance concerns such as refusal to shave body hair
• No manipulable lesion in L3, L4, L5 or SI joints (The absence of typical palpatory characteristics as well as the absence of a global assessment that would indicate that spinal manipulation is likely to generate a positive therapeutic effect, even without the presence of standard palpatory findings)
• Comorbid Conditions:
• Serious Contaminant Illness
• Inflammatory or Destructive Spinal Tissue change
• Ankylosing Spondylitis
• Fibromyalgia
• Rheumatoid Arthritis
• Neuromuscular Disease (e.g. Parkinson's, Muscular Dystrophy, Cerebral Palsy, or Myasthenia gravis)
• Spinal Surgery \< 6 mo
• Suspicion of drug or alcohol abuse
• Uncontrolled hypertension
• Peripheral Arterial Disease
• Undetermined, infectious or visceral source of LBP
• Other comorbid conditions prohibiting treatment and/or testing

Sponsors & Collaborators

• Palmer College of Chiropractic: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• University of Iowa: collaborator

Study Sites (1)

Palmer College of Chiropractic

Davenport, Iowa, 52803, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ting Xia, PhD (Principal Investigator)
• Organization: Palmer College of Chiropractic

Ting.Xia@palmer.edu

563-884-5161

Study Officials

• Ting Xia, PhD

  Palmer College of Chiropractic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 26, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 31, 2017
• Results First Posted: July 31, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)