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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02245425
Other study ID # 2014096
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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