Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The broad long-term objective is to develop an objective biomarker for spinal health based on aberrant or abnormal movement patterns during functional activities to better target spinal manipulation therapy (SMT) and other conservative treatments. The central hypotheses are a) that aberrant spinal motions and their location (area and level) are indicative of underlying spinal dysfunction, and b) that quantified 3D cervical spine intersegmental and global motion patterns during functional tasks can be used as a biomarker for subsequent clinical studies aimed at normalizing cervical kinematics.
Specific Aim: Determine the extent to which SMT can modulate, or normalize, intersegmental motion in patients with neck pain. Rationale: SMT is a force-based biomechanical event whose hypothesized mechanism of action relies on moving the segment into the para-physiological zone, resulting in normalization of spinal kinematic function. Hypothesis: Severity of abnormal or aberrant motion, identified in those with NP, will improve following SMT. Approach: Participants with chronic mechanical neck pain will be recruited and randomized into one of three groups: 1) No Treatment, 2) Light Massage (pseudo- sham), and 3) Spinal Manipulative Therapy. Using a repeated measures study design, metrics of quality of spinal motion will be compared before and after the prescribed intervention.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No treatment group | No Intervention | No Treatment: participants will be placed in a similar position to the other groups for the same duration, but no treatment or touch will be administered. | |
| Pseudo sham group | Sham Comparator | Light massage group |
|
| Experimental group | Experimental | Spinal Manipulative therapy group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMT | Other | SMT will be provided by a licensed chiropractor with at least 5 years' experience. Treatment will last 15 to 20 minutes each and include a brief history and examination of the cervical spine. SMT will consist of low velocity, variable amplitude spinal mobilization to the cervical spine - Maitland grades 3 or 4. Spinal segments will be determined by the chiropractor using manual palpation and the patients' response to care. Drop-table or instrument-assisted SMT will not be allowed. |
| Measure | Description | Time Frame |
|---|---|---|
| Intersegmental and Global Range of Motion | analysis will consist of calculating the percent contribution of each functional spinal unit to the overall global motion. To do that, cervical spine ROM (global and intersegmental), angular change between the beginning and end of motion, will be quantified for all planar bending directions. | 1 hr |
| Measure | Description | Time Frame |
|---|---|---|
| Neck pain intensity | will be measured using the 11-box numerical rating scale (NRS). The NRS is a reliable and valid outcome measure for individuals with pain and is recommended by both the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) group and the NIH task force on research standards for back pain. | 1 hr |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephany Nathe | Contact | nathe039@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Arin Ellingson, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55414 | United States |
Not provided
| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Participants with chronic mechanical neck pain will be recruited and randomized into one of three groups: 1) No Treatment, 2) Light Massage (pseudo- sham), and 3) Spinal Manipulative Therapy. Using a repeated measures study design, metrics of quality of spinal motion will be compared before and after the prescribed intervention.
Not provided
Not provided
Not provided
|
| Light Massage | Other | Light Massage will be provided as a pseudo-sham intervention to control for time, attention, and touch by a licensed chiropractor with at least 5 years' experience to control for touch and is intended to be delivered gentler and shorter than recommended for therapeutic massage. |
|
| Neck disability | will be measured using the Neck Disability Index (NDI), an instrument previously shown to be reliable and valid for adults with neck pain. | 1 hr |
| physical function | will also be measured using the relevant domains of the PROMIS-29 Profile v2.0 Instrument - recommended by an NIH task force on research standards for back pain. | 1 hr |
| depression | will also be measured using the relevant domains of the PROMIS-29 Profile v2.0 Instrument - recommended by an NIH task force on research standards for back pain. | 1 hr |
| sleep disturbance | will also be measured using the relevant domains of the PROMIS-29 Profile v2.0 Instrument - recommended by an NIH task force on research standards for back pain. | 1 hr |
| Pain interference | will also be measured using the relevant domains of the PROMIS-29 Profile v2.0 Instrument - recommended by an NIH task force on research standards for back pain. | 1 hr |
| Fear of pain assessment | Fear-Avoidance Beliefs Questionnaire (FABQ) 68 will also be collected to assess fear of pain and aversion to physical activity/movement. | 1 hr |
| Overall function assessment | The Short Form-36 (SF-36) will also be collected to assess overall function. | 1 hr |