NCT02287337

Brief Summary

The purpose of this study is to see if a recently developed clinical prediction rule (CPR) will successfully identify which patients with neck pain will respond rapidly and favorably to manipulation of their cervical spine.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

November 3, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2017

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

November 3, 2014

Last Update Submit

October 18, 2019

Conditions

Cervicalgia

Keywords

Neck pain

Outcome Measures

Primary Outcomes (1)

  • Neck Disability Index

    10-item patient self-report measure of perceived disability

    6 months

Secondary Outcomes (3)

  • Medication Use

    6 months

  • Global Rating of Change Scale

    6 months

  • Numeric Pain Rating Scale

    6 months

Study Arms (2)

Manipulation

EXPERIMENTAL

Patients will receive cervical manipulation on 2 visits and then a further 3 visits of therapeutic exercises

Procedure: ManipulationProcedure: Exercise

Exercise

OTHER

Patients will receive 5 visits of therapeutic exercises

Procedure: Exercise

Interventions

ManipulationPROCEDURE

High velocity low amplitude thrust joint manipulation to cervical spine facet joints

Manipulation
ExercisePROCEDURE

Therapeutic exercises to the cervical, thoracic and scapular musculature

ExerciseManipulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary complaint of mechanical neck pain with or without unilateral upper extremity symptoms (mechanical neck pain is defined as neck pain/ symptoms that are altered/ affected by activity, movement and posture)
  • NDI score at least 10 points out of 50.

You may not qualify if:

  • Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, prolonged history of steroid use, etc.)
  • History of whiplash injury within the past six weeks
  • Diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms
  • Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
  • Two or more positive neurologic signs consistent with nerve root compression, including any two of the following: a. Muscle weakness involving a major muscle group of the upper extremity b. Diminished upper extremity muscle stretch reflex (biceps brachii, Brachioradialis, or triceps reflex) c. Diminished or absent sensation to pinprick in any upper extremity dermatome
  • Prior surgery to the neck or thoracic spine
  • Pending legal action regarding their neck pain
  • Insufficient English language skills to complete all questionnaires
  • Inability to comply with treatment and follow-up schedule

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada Las Vegas

Las Vegas, Nevada, 89178, United States

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 3, 2014

First Posted

November 10, 2014

Study Start

September 1, 2015

Primary Completion

August 26, 2017

Study Completion

August 26, 2017

Last Updated

October 22, 2019

Record last verified: 2019-10

Locations

US(1)