Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain

A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Other: Supine Thoracic Spine Manipulation; Other: Prone Thoracic Spine Manipulation

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • A.T. Still University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Other: Supine Thoracic Spine Manipulation; 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.
Active Comparator: 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).	Other: Prone Thoracic Spine Manipulation; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: A.T. Still University of Health Sciences
• Investigators: Principal Investigator: John Heick, PT, DPT, A.T. Still University

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): April 30, 2015
• Study Completion (Actual): July 8, 2015

Study Registration Dates

• First Submitted: September 17, 2014
• First Submitted That Met QC Criteria: September 17, 2014
• First Posted (Estimate): September 19, 2014

Study Record Updates

• Last Update Posted (Actual): November 9, 2018
• Last Update Submitted That Met QC Criteria: November 7, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Range of Motion; Disability; Neck pain; Thoracic spine manipulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 2014096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO