Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02245425
• Other study ID #: 2014096
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: July 8, 2015

Study information

• Verified date: November 2018
• Source: A.T. Still University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 8, 2015
• Est. primary completion date: April 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	A.T. Still University	Mesa	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
A.T. Still University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale (NPRS)	Patient-rated assessment of pain on scale of 0-10	Baseline (Week 0)
Primary	NPRS	Patient-rating of pain on a scale of 0-10	Change from Week 0 to Week 1
Primary	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
Primary	Neck Disability Index (NDI)	10 Question patient-rated outcome measures specific to neck disability	Baseline (Week 0)
Primary	NDI	10 Question patient-rated outcome measures specific to neck disability	Change from Baseline (Week 0) to Week 1
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	Neck Range of Motion (ROM)	Cervical rotation and lateral flexion measured with goniometer.	Baseline (Week 0)
Primary	Neck ROM	Cervical rotation and lateral flexion measured with goniometer.	Change from Baseline (Week 0) to Week 1
Primary	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