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Clinical Trials/NCT02245425
NCT02245425
Completed
Not Applicable

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

A.T. Still University of Health Sciences1 site in 1 country21 target enrollmentSeptember 2014
ConditionsNeck Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neck Pain
Sponsor
A.T. Still University of Health Sciences
Enrollment
21
Locations
1
Primary Endpoint
Numeric Pain Rating Scale (NPRS)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
July 8, 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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
  • serious pathologies or conditions (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, history of prolonged steroid use)
  • hyperreflexia

Outcomes

Primary Outcomes

Numeric Pain Rating Scale (NPRS)

Time Frame: Baseline (Week 0)

Patient-rated assessment of pain on scale of 0-10

Neck ROM

Time Frame: 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.

NPRS

Time Frame: 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)

Time Frame: Baseline (Week 0)

10 Question patient-rated outcome measures specific to neck disability

Shortened Version of Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH)

Time Frame: Baseline (Week 0)

11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.

NDI

Time Frame: 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

QuickDASH

Time Frame: 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)

Time Frame: Baseline (Week 0)

Cervical rotation and lateral flexion measured with goniometer.

Study Sites (1)

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