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Completed

NCT Number: NCT02245425

Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain

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.

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

A.T. Still University

Mesa, Arizona, 85206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • unsteadiness during gait
  • Nystagmus
  • Loss of visual acuity
  • Impaired sensation of the face
  • Altered taste
  • The presence of pathological reflexes
  • pregnancy or considering pregnancy

Treatment and study plan

Supine Thoracic Spine Manipulation

Other

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.

Prone Thoracic Spine Manipulation

Other

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.

Primary outcomes

  1. Numeric Pain Rating Scale (NPRS)

    Time frame: Baseline (Week 0)

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

  2. NPRS

    Time frame: Change from Week 0 to Week 1

    Patient-rating of pain on a scale of 0-10

  3. 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

  4. Neck Disability Index (NDI)

    Time frame: Baseline (Week 0)

    10 Question patient-rated outcome measures specific to neck disability

  5. NDI

    Time frame: Change from Baseline (Week 0) to Week 1

    10 Question patient-rated outcome measures specific to neck disability

  6. 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

  7. 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.

  8. QuickDASH

    Time frame: Change from Week 0 to Week 1

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

  9. 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.

  10. Neck Range of Motion (ROM)

    Time frame: Baseline (Week 0)

    Cervical rotation and lateral flexion measured with goniometer.

  11. Neck ROM

    Time frame: Change from Baseline (Week 0) to Week 1

    Cervical rotation and lateral flexion measured with goniometer.

  12. 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.

Sponsors and collaborators

Lead sponsor

A.T. Still University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 19, 2014
Registry last updated
Nov 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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