Clinical trial NCT02245425: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Neck pain
Thoracic spine manipulation
Range of Motion
Disability
Lead sponsor: A.T. Still University of Health Sciences
Sponsor class: OTHER
First posted: 2014-09-19
Enrollment: 21
Sex: ALL
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

  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

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline (Week 0)
measure: NPRS
timeFrame: Change from Week 0 to Week 1
measure: NPRS
timeFrame: Change from Baseline (Week 0) and Follow-up (Week 3) and From Week 1 and Week 3
measure: Neck Disability Index (NDI)
timeFrame: Baseline (Week 0)
measure: NDI
timeFrame: Change from Baseline (Week 0) to Week 1
measure: NDI
timeFrame: Change from Baseline (Week 0) to Follow-up (Week 3) and from Week 1 to Week 3
measure: Shortened Version of Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH)
timeFrame: Baseline (Week 0)
measure: QuickDASH
timeFrame: Change from Week 0 to Week 1
measure: QuickDASH
timeFrame: Change from Baseline (Week 0) to Follow-up (Week 3) and from Week 1 to Week 3
measure: Neck Range of Motion (ROM)
timeFrame: Baseline (Week 0)
measure: Neck ROM
timeFrame: Change from Baseline (Week 0) to Week 1
measure: Neck ROM
timeFrame: Change from Baseline (Week 0) to Follow-up (Week 3) and between Week 1 and Week 3
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: A.T. Still University
state: Arizona
Study officials:
affiliation: A.T. Still University
name: John Heick, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References: