A 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 Control Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02972710
• Other study ID #: 962801-1
• Status: Suspended
• Phase: N/A
• First received: November 17, 2016
• Last updated: March 9, 2018
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: March 2018
• Source: Northern Arizona University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study will be conducted at the Musculoskeletal clinical facility in the Dept. of Physical Therapy and Athletic Training, Northern Arizona University, Flagstaff AZ. The investigators aim to test a maximum of 76 participants in this study. A phone screening will determine initial eligibility. If the participant meets the inclusion criteria and is not excluded after the phone screen, an appointment will be scheduled. Final eligibility will be determined in the initial session after the participant completes the outcome measures and is evaluated by a licensed physical therapist.

Participants 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.

After completion of the baseline assessment, qualified participants will be randomly assigned to either a supine or prone thoracic spine thrust manipulation intervention.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 76
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

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 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

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 thrust manipulation
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 thrust manipulation
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.

Locations

Country	Name	City	State
United States	Northern Arizona University	Flagstaff	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Northern Arizona University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)