A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain

NCT02972710 | Suspended

• 1 other identifier: 962801-1
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is 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 individuals experiencing neck pain.

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (4)

• Numerical Pain Rating Scale (NPRS)

  Each participant's neck pain intensity will be assessed by use of the Numeric Pain Rating Scale (NPRS of 0-10)

  Change in NPRS scores at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)

• Neck Range of Motion

  Cervical range of motion measured with the Goniometer

  Change in Neck ROM at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)

• Neck Disability Index (NDI)

  The Neck Disability Index (NDI) is a self-reported measure of disability consisting of a 0-50 point scale where higher scores indicate higher levels of disability

  Change in NDI at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)

• Shortened version of the Disabilities of the Arm, Shoulder, and Hand questionnaire (Quick DASH)

  The shortened version of the Disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire is a self-report measure of function that can assess how neck pain may be impacting daily activities that require use of the upper limb

  Change in QuickDASH scores at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)

Study Arms (2)

Supine thoracic spine manipulation

ACTIVE COMPARATOR

Supine thoracic spine thrust manipulation (lying face-up on the treatment table) will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2)

Other: Supine thoracic spine thrust manipulation

Seated thoracic spine manipulation

ACTIVE COMPARATOR

Seated thoracic spine thrust manipulation will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2).

Other: Seated thoracic spine thrust manipulation

Interventions

Supine thoracic spine thrust manipulation OTHER

The participant will be positioned 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.

Supine thoracic spine manipulation

Seated thoracic spine thrust manipulation OTHER

The participant will be positioned 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.

Seated thoracic spine manipulation

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between 20 and 50 years of age (inclusive)
• 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 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 possible pain"
• 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

You may not qualify if:

• 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 spinal 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

Sponsors & Collaborators

• Northern Arizona University: lead

Study Sites (1)

Northern Arizona University

Flagstaff, Arizona, 86011, United States

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• John Heick, PT, PhD, DPT

  Northern Arizona University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Physical Therapy and Athletic Training

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 23, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)