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Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supine Thoracic Spine Manipulation
Prone Thoracic Spine Manipulation
Sponsored by
A.T. Still University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Neck pain, Thoracic spine manipulation, Range of Motion, Disability

Eligibility Criteria

22 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

    1. serious pathologies or conditions (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, history of prolonged steroid use)
    2. hyperreflexia
    3. unsteadiness during gait
    4. Nystagmus
    5. Loss of visual acuity
    6. Impaired sensation of the face
    7. Altered taste
    8. The presence of pathological reflexes
    9. pregnancy or considering pregnancy

Sites / Locations

  • A.T. Still University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Supine Thoracic Spine Manipulation

Prone Thoracic Spine Manipulation

Arm Description

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)

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).

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale (NPRS)
Patient-rated assessment of pain on scale of 0-10
NPRS
Patient-rating of pain on a scale of 0-10
NPRS
Patient-rating of pain on a scale of 0-10
Neck Disability Index (NDI)
10 Question patient-rated outcome measures specific to neck disability
NDI
10 Question patient-rated outcome measures specific to neck disability
NDI
10 Question patient-rated outcome measures specific to neck disability
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.
QuickDASH
11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.
QuickDASH
11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.
Neck Range of Motion (ROM)
Cervical rotation and lateral flexion measured with goniometer.
Neck ROM
Cervical rotation and lateral flexion measured with goniometer.
Neck ROM
Cervical rotation and lateral flexion measured with goniometer.

Secondary Outcome Measures

Full Information

First Posted
September 17, 2014
Last Updated
November 7, 2018
Sponsor
A.T. Still University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02245425
Brief Title
Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain
Official Title
A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 30, 2015 (Actual)
Study Completion Date
July 8, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
A.T. Still University of Health Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients will be involved in the study over a 4 week period. Each participant will be asked to attend 4 sessions, with one week in between each session as follows: Week 0 = baseline assessment and treatment 1; Week 1= treatment 2; Week 2 = treatment 3; and week 4 = follow-up assessment. Patients who meet the inclusion/exclusion criteria will be randomized to either a supine or prone thoracic spine thrust manipulation intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck pain, Thoracic spine manipulation, Range of Motion, Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supine Thoracic Spine Manipulation
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Prone Thoracic Spine Manipulation
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Supine Thoracic Spine Manipulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Prone Thoracic Spine Manipulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
Patient-rated assessment of pain on scale of 0-10
Time Frame
Baseline (Week 0)
Title
NPRS
Description
Patient-rating of pain on a scale of 0-10
Time Frame
Change from Week 0 to Week 1
Title
NPRS
Description
Patient-rating of pain on a scale of 0-10
Time Frame
Change from Baseline (Week 0) and Follow-up (Week 3) and From Week 1 and Week 3
Title
Neck Disability Index (NDI)
Description
10 Question patient-rated outcome measures specific to neck disability
Time Frame
Baseline (Week 0)
Title
NDI
Description
10 Question patient-rated outcome measures specific to neck disability
Time Frame
Change from Baseline (Week 0) to Week 1
Title
NDI
Description
10 Question patient-rated outcome measures specific to neck disability
Time Frame
Change from Baseline (Week 0) to Follow-up (Week 3) and from Week 1 to Week 3
Title
Shortened Version of Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH)
Description
11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.
Time Frame
Baseline (Week 0)
Title
QuickDASH
Description
11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.
Time Frame
Change from Week 0 to Week 1
Title
QuickDASH
Description
11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.
Time Frame
Change from Baseline (Week 0) to Follow-up (Week 3) and from Week 1 to Week 3
Title
Neck Range of Motion (ROM)
Description
Cervical rotation and lateral flexion measured with goniometer.
Time Frame
Baseline (Week 0)
Title
Neck ROM
Description
Cervical rotation and lateral flexion measured with goniometer.
Time Frame
Change from Baseline (Week 0) to Week 1
Title
Neck ROM
Description
Cervical rotation and lateral flexion measured with goniometer.
Time Frame
Change from Baseline (Week 0) to Follow-up (Week 3) and between Week 1 and Week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 The presence of pathological reflexes pregnancy or considering pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Heick, PT, DPT
Organizational Affiliation
A.T. Still University
Official's Role
Principal Investigator
Facility Information:
Facility Name
A.T. Still University
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain

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