Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain

Not Applicable

Completed

• Conditions: Neck Pain
• Interventions: Other: Supine Thoracic Spine Manipulation; Other: Prone Thoracic Spine Manipulation

• Registration Number: NCT02245425
• Lead Sponsor: A.T. Still University of Health Sciences

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-17
• Study First Posted: 2014-09-19
• Primary Completion: 2015-04-30
• Study Completion: 2015-07-08
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-07
• Last Update Posted: 2018-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supine Thoracic Spine Manipulation	Supine Thoracic Spine Manipulation	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 Thoracic Spine Manipulation	Prone Thoracic Spine Manipulation	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).

Primary Outcome Measures

Name	Time	Method
QuickDASH	Change from Baseline (Week 0) to Follow-up (Week 3) and from Week 1 to Week 3	11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.
Neck Range of Motion (ROM)	Baseline (Week 0)	Cervical rotation and lateral flexion measured with goniometer.
Numeric Pain Rating Scale (NPRS)	Baseline (Week 0)	Patient-rated assessment of pain on scale of 0-10
Neck ROM	Change from Baseline (Week 0) to Follow-up (Week 3) and between Week 1 and Week 3	Cervical rotation and lateral flexion measured with goniometer.
Shortened Version of Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH)	Baseline (Week 0)	11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.
NPRS	Change from Baseline (Week 0) and Follow-up (Week 3) and From Week 1 and Week 3	Patient-rating of pain on a scale of 0-10
Neck Disability Index (NDI)	Baseline (Week 0)	10 Question patient-rated outcome measures specific to neck disability
NDI	Change from Baseline (Week 0) to Follow-up (Week 3) and from Week 1 to Week 3	10 Question patient-rated outcome measures specific to neck disability

Trial Locations

Locations (1)

A.T. Still University; 🇺🇸 Mesa, Arizona, United States