Neck PainNCT06312696
Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy
A study testing SMT and Light Massage in people with Neck Pain, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- SMT and Light Massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stephany Nathe contact
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Stephany Nathe, nathe039@umn.edu
About this study
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.
- Conditions
- Neck Pain
- Being tested
- SMT, Light Massage
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMTOther
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 MassageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Light Massage |
| Experimental group | Experimental | Spinal Manipulative therapy group Receives: Other: SMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hr
Secondary outcomes (8)
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.
Measured: 1 hr
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 hr
Overall function assessment
The Short Form-36 (SF-36) will also be collected to assess overall function.
Measured: 1 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arin Ellingson, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312696
- Sponsor's protocol ID
- PT-2024-32814.
- Status last verified
- Apr 2026
- First submitted
- 8 Mar 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy
- ClinicalTrials.gov ID
- NCT06312696
- Acronym / sponsor ID
- PT-2024-32814.
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Light MassageLight massage group |
| Experimental group | Experimental | Other: SMTSpinal Manipulative therapy group |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMTSMT 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. | Other | Experimental group |
| Light MassageLight 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. | Other | Pseudo sham group |
Primary outcome
Intersegmental and Global Range of Motion
Time frame: 1 hr
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.
8 secondary outcomes
Neck pain intensity
Time frame: 1 hr
Neck disability
Time frame: 1 hr
physical function
Time frame: 1 hr
depression
Time frame: 1 hr
sleep disturbance
Time frame: 1 hr
Pain interference
Time frame: 1 hr
Fear of pain assessment
Time frame: 1 hr
Overall function assessment
Time frame: 1 hr
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephany Nathe contact
Arin Ellingson, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMT and Light Massage in people with Neck Pain, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephany Nathe (nathe039@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intersegmental and Global Range of Motion (time frame: 1 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.