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
About this trial
This is an interventional treatment trial for Neck Pain
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
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
NCT ID
NCT02972710
First Posted
November 17, 2016
Last Updated
March 9, 2018
Sponsor
Northern Arizona University
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
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A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain
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