NCT02245425

Brief Summary

This study is designed to compare the short-term effects of two different thoracic spine thrust manipulation techniques on neck range-of-motion, pain, and self-reported disability in people with neck pain. The null hypothesis is that there will be no differences between the two manipulation techniques for short-term effects on neck range-of-motion, pain, and self-reported disability in people with neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

September 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2015

Completed
Last Updated

November 9, 2018

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

September 17, 2014

Last Update Submit

November 7, 2018

Conditions

Neck Pain

Keywords

Neck painThoracic spine manipulationRange of MotionDisability

Outcome Measures

Primary Outcomes (12)

  • Numeric Pain Rating Scale (NPRS)

    Patient-rated assessment of pain on scale of 0-10

    Baseline (Week 0)

  • NPRS

    Patient-rating of pain on a scale of 0-10

    Change from Week 0 to Week 1

  • NPRS

    Patient-rating of pain on a scale of 0-10

    Change from Baseline (Week 0) and Follow-up (Week 3) and From Week 1 and Week 3

  • Neck Disability Index (NDI)

    10 Question patient-rated outcome measures specific to neck disability

    Baseline (Week 0)

  • NDI

    10 Question patient-rated outcome measures specific to neck disability

    Change from Baseline (Week 0) to Week 1

  • NDI

    10 Question patient-rated outcome measures specific to neck disability

    Change from Baseline (Week 0) to Follow-up (Week 3) and from Week 1 to Week 3

  • Shortened Version of Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH)

    11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.

    Baseline (Week 0)

  • QuickDASH

    11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.

    Change from Week 0 to Week 1

  • QuickDASH

    11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.

    Change from Baseline (Week 0) to Follow-up (Week 3) and from Week 1 to Week 3

  • Neck Range of Motion (ROM)

    Cervical rotation and lateral flexion measured with goniometer.

    Baseline (Week 0)

  • Neck ROM

    Cervical rotation and lateral flexion measured with goniometer.

    Change from Baseline (Week 0) to Week 1

  • Neck ROM

    Cervical rotation and lateral flexion measured with goniometer.

    Change from Baseline (Week 0) to Follow-up (Week 3) and between Week 1 and Week 3

Study Arms (2)

Supine Thoracic Spine Manipulation

ACTIVE COMPARATOR

Supine (lying face-up on the treatment table) thoracic spine thrust manipulation will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2)

Other: Supine Thoracic Spine Manipulation

Prone Thoracic Spine Manipulation

ACTIVE COMPARATOR

Prone (lying face down on the treatment table) thoracic spine thrust manipulation will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2).

Other: Prone Thoracic Spine Manipulation

Interventions

Supine Thoracic Spine ManipulationOTHER

Position patient so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing. The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician.

Supine Thoracic Spine Manipulation
Prone Thoracic Spine ManipulationOTHER

Position patient so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing. The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician.

Prone Thoracic Spine Manipulation

Eligibility Criteria

Age22 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between 22 and 50 years of age
  • Primary complaint of neck pain with or without symptoms that spread down into one arm
  • Overall rating of neck pain intensity is at least 3/10; the overall rating is the overall average of the participant's rating of current, least, and worst pain experienced over the previous 24 hours on separate numeric pain rating scales where 0 corresponds to "no pain" and 10 corresponds to "worst pain possible".
  • Neck Disability Index (NDI) score \> 10 points (measure of self-reported disability with a 0 to 50 point scale where higher scores indicate higher levels of disability).
  • Proficient in speaking and reading English to complete outcome questionnaires

You may not qualify if:

  • Neck pain related to a motor vehicle accident or other trauma within the previous 6 weeks
  • Neck pain that spreads down into both arms
  • Low back pain or thoracic origin of pain
  • Nerve root involvement; defined as the presence of two or more neurological findings (e.g. decreased strength, diminished deep tendon reflex, or decreased sensation) at the same nerve root level
  • Diagnosis of cervical spine stenosis (narrowing of the central canal that contains the spinal cord)
  • History of spinal tumors, spinal infection, cervical spine fracture, or previous neck surgery
  • Pending legal action related to current episode of neck pain
  • Contraindications to thoracic spine thrust manipulation
  • serious pathologies or conditions (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, history of prolonged steroid use)
  • hyperreflexia
  • unsteadiness during gait
  • Nystagmus
  • Loss of visual acuity
  • Impaired sensation of the face
  • Altered taste
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A.T. Still University

Mesa, Arizona, 85206, United States

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John Heick, PT, DPT

    A.T. Still University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2014

First Posted

September 19, 2014

Study Start

September 1, 2014

Primary Completion

April 30, 2015

Study Completion

July 8, 2015

Last Updated

November 9, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)