search
Back to results

A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain

Primary Purpose

Neck Pain

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supine thoracic spine thrust manipulation
Seated thoracic spine thrust manipulation
Sponsored by
Northern Arizona University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

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

Inclusion Criteria:

  • Between 20 and 50 years of age (inclusive)
  • 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 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 possible pain"
  • 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 spinal 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

  • Northern Arizona University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Supine thoracic spine manipulation

Seated thoracic spine manipulation

Arm Description

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

Seated thoracic spine thrust manipulation will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2).

Outcomes

Primary Outcome Measures

Numerical Pain Rating Scale (NPRS)
Each participant's neck pain intensity will be assessed by use of the Numeric Pain Rating Scale (NPRS of 0-10)
Neck Range of Motion
Cervical range of motion measured with the Goniometer
Neck Disability Index (NDI)
The Neck Disability Index (NDI) is a self-reported measure of disability consisting of a 0-50 point scale where higher scores indicate higher levels of disability
Shortened version of the Disabilities of the Arm, Shoulder, and Hand questionnaire (Quick DASH)
The shortened version of the Disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire is a self-report measure of function that can assess how neck pain may be impacting daily activities that require use of the upper limb

Secondary Outcome Measures

Full Information

First Posted
November 17, 2016
Last Updated
March 9, 2018
Sponsor
Northern Arizona University
search

1. Study Identification

Unique Protocol Identification Number
NCT02972710
Brief Title
A 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 Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Suspended
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern Arizona University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is 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 individuals experiencing neck pain.
Detailed Description
The study will be conducted at the Musculoskeletal clinical facility in the Dept. of Physical Therapy and Athletic Training, Northern Arizona University, Flagstaff AZ. The investigators aim to test a maximum of 76 participants in this study. A phone screening will determine initial eligibility. If the participant meets the inclusion criteria and is not excluded after the phone screen, an appointment will be scheduled. Final eligibility will be determined in the initial session after the participant completes the outcome measures and is evaluated by a licensed physical therapist. Participants 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. After completion of the baseline assessment, qualified participants will be randomly assigned 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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Supine thoracic spine manipulation
Arm Type
Active Comparator
Arm Description
Supine thoracic spine thrust manipulation (lying face-up on the treatment table) will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2)
Arm Title
Seated thoracic spine manipulation
Arm Type
Active Comparator
Arm Description
Seated 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 thrust manipulation
Intervention Description
The participant will be positioned 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)
Seated thoracic spine thrust manipulation
Intervention Description
The participant will be positioned 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
Numerical Pain Rating Scale (NPRS)
Description
Each participant's neck pain intensity will be assessed by use of the Numeric Pain Rating Scale (NPRS of 0-10)
Time Frame
Change in NPRS scores at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
Title
Neck Range of Motion
Description
Cervical range of motion measured with the Goniometer
Time Frame
Change in Neck ROM at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
Title
Neck Disability Index (NDI)
Description
The Neck Disability Index (NDI) is a self-reported measure of disability consisting of a 0-50 point scale where higher scores indicate higher levels of disability
Time Frame
Change in NDI at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
Title
Shortened version of the Disabilities of the Arm, Shoulder, and Hand questionnaire (Quick DASH)
Description
The shortened version of the Disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire is a self-report measure of function that can assess how neck pain may be impacting daily activities that require use of the upper limb
Time Frame
Change in QuickDASH scores at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 20 and 50 years of age (inclusive) 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 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 possible pain" 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 spinal 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, PhD, DPT
Organizational Affiliation
Northern Arizona University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Arizona University
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86011
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain

We'll reach out to this number within 24 hrs