Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain

NCT ID: NCT02245425

Last Updated: 2018-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-07-08

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.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Supine Thoracic Spine Manipulation

Intervention Type: 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

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).

Group Type: ACTIVE_COMPARATOR

Prone Thoracic Spine Manipulation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

A.T. Still University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Heick, PT, DPT

Role: PRINCIPAL_INVESTIGATOR

A.T. Still University

Locations

A.T. Still University

Mesa, Arizona, United States

Countries

United States

Other Identifiers

2014096

Identifier Type: -

Identifier Source: org_study_id