A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain

NCT ID: NCT02972710

Last Updated: 2018-03-13

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-11-30

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.

Detailed 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.

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 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)

Group Type: ACTIVE_COMPARATOR

Supine thoracic spine thrust manipulation

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Seated thoracic spine thrust manipulation

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern Arizona University

OTHER

Sponsor Role: lead

Responsible Party

Tarang Jain

Assistant Professor - Physical Therapy and Athletic Training

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Heick, PT, PhD, DPT

Role: PRINCIPAL_INVESTIGATOR

Northern Arizona University

Locations

Northern Arizona University

Flagstaff, Arizona, United States

Countries

United States

Other Identifiers

962801-1

Identifier Type: -

Identifier Source: org_study_id