Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy

Neck Pain Clinical Trial

Official title:

Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06312696
• Other study ID #: PT-2024-32814.
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 1, 2027

Study information

• Verified date: May 2024
• Source: University of Minnesota
• Contact: Stephany Nathe
• Email: nathe039[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Nonspecific, mechanical neck pain equivalent to grades I or II (Bone and Joint Task Force on Neck Pain and Its Associated Disorders classification2 for >12 weeks
• Ages 18 to 39
• Pain intensity >3 (0-10 scale)

Exclusion Criteria:

• American Society of Anesthesiology Class III conditions and/or serious mental health conditions
• Botox injections (which resulted in clinical relief) in the past 3 months
• Chronic opioid use
• Contraindications to spinal manipulation (e.g. cervical instability; complicating neurological conditions) Spinal manipulation or mobilization of cervical spine in prior 6 months
• Ongoing non-pharmacological treatment for neck pain
• History of cervical spine surgery
• Pregnancy, currently trying to get pregnant, lactation
• Contraindications to radiation exposure

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• SMT
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.
• Light Massage
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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall function assessment	The Short Form-36 (SF-36) will also be collected to assess overall function.	1 hr