NCT03078114

Brief Summary

The purpose of this study is to examine the change of nervous system activity before and after spinal manipulation treatment program in people with low back pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

4 years

First QC Date

March 1, 2017

Last Update Submit

March 10, 2017

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Threshold measured using Pain Pressure Threshold (PPT) testing

    Outcome will be measured using Pain Pressure Threshold (PPT) testing. Pressure will be applied to subjects using a digital algometer. Three trials for PPT will be done and the mean value will be calculated.

    Change from Pre-treatment to Post-treatment, 2 Weeks

Secondary Outcomes (3)

  • Change in function measured using the Oswestry Disability Index (ODI)

    Change from Baseline to Week 2

  • Change in Low Back Pain measured using the Numerical Pain Rating Scale (NPRS)

    Change from Baseline to Week 2

  • Change in Fear Avoidance Beliefs Questionnaire (FABQ)

    Change from Baseline to Week 2

Study Arms (2)

Spinal Manipulation

EXPERIMENTAL

Subjects with subacute low back pain. Subjects will receive 6 treatments of Spinal Manipulation (SM) over 2 consecutive weeks

Other: Spinal Manipulation

Placebo Spinal Manipulation

PLACEBO COMPARATOR

Subjects with subacute low back pain. Subjects will be asked to visit the clinic for 6 times. The clinician will go through SM motions but the spine will not actually be manipulated.

Other: Placebo Spinal Manipulation

Interventions

Spinal ManipulationOTHER

The subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to manipulate the spine.

Spinal Manipulation
Placebo Spinal ManipulationOTHER

The subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to simulate manipulating the spine.

Placebo Spinal Manipulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of subacute low back pain
  • Ability to read and understand English

You may not qualify if:

  • Previous low back surgery
  • Severe structural spinal deformity
  • Neurological compromise resulting in current nerve root entrapment
  • Spinal cord compression
  • Tumor
  • Severe spinal instability
  • Severe osteoporosis
  • Psychiatric disease
  • Head trauma
  • Spinal infection
  • Known cardiovascular or metabolic disease
  • Known neurological, neuromuscular or orthopedic problems that might prevent them from participating in manual therapy interventions
  • Pregnancy
  • Mini-Mental State Examination score \< 25
  • Body Mass Index (BMI) \< 18 or \> 30
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Saint Mary

Leavenworth, Kansas, 66048, United States

Location

Related Publications (1)

  • Bond BM, Kinslow CD, Yoder AW, Liu W. Effect of spinal manipulative therapy on mechanical pain sensitivity in patients with chronic nonspecific low back pain: a pilot randomized, controlled trial. J Man Manip Ther. 2020 Feb;28(1):15-27. doi: 10.1080/10669817.2019.1572986. Epub 2019 Mar 5.

    PMID: 30935324DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Wen Liu, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2017

First Posted

March 13, 2017

Study Start

May 1, 2012

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

March 13, 2017

Record last verified: 2017-03

Locations

US(2)