CompletedNot Applicable

Association Between Conditioned Pain Modulation and the 4-week Response to Spinal Mobilization in Adults With Chronic Neck Pain

United States31 participantsStarted 2021-06-21

Plain-language summary

The goal of this observational study is to learn if there is a relationship between conditioned pain modulation or CPM (a test of your brain's ability to inhibit pain) and longitudinal clinical outcomes following one spinal/joint mobilization (commonly used to treat neck pain) session in individuals with chronic mild neck pain between the age of 18-55 years old. The main questions it aims to answer are: * Is baseline CPM significantly associated with baseline outcomes: (a) pain (NPRS), (b) perceived disability (NDI), and (c) perceived recovery (GPR)? * Is baseline CPM associated with longitudinal trend in outcomes: pain (NPRS), perceived disability (NDI), and perceived recovery (GPR)? * Is the change in CPM post-joint mobilization (post-JM) associated with longitudinal trend in outcomes: pain (NPRS), perceived disability (NDI), and perceived recovery (GPR)? Participants will receive CPM protocol before and after the joint mobilization. The CPM protocol includes a handheld pressure meter applied to 3 main sites (neck, shoulder blade and leg bone) to measure when light touch first becomes a mild experience of pain as well as placing your hand in cold water. They will receive joint/spinal mobilization of the neck (cervical spine), explanation of why it might work and advise to continue their usual activities of daily living and to avoid receiving any physical therapy treatments/interventions (such as exercise or joint mobilization; they may continue taking their medication/s, however) the entire 4-weeks while they are in the study.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * neck pain classified as Neck Pain and Associated Disorder I (NAD) I with a duration of 3-60 months * a 3 or higher pain scale rating out of 10 on the Numeric Pain Rating Scale * modified STarTBack tool (modified for neck pain) classified as low risk (\< 3 out of 9) * a Neck Disability Index scored at 10% or higher Exclusion Criteria: * prior spinal surgery, those with serious underlying pathology including neurologic, cardiovascular, hypertension, diabetes mellitus, inflammatory arthritis, osteoporosis, hemophilia, cancer, contra-indications to cervical spine joint mobilization (or spinal mobilization of the neck) \[e.g., a history of fainting spells or loss of consciousness, presently on blood thinners\] * those who received spinal mobilization of the neck (or cervical spine joint mobilization) or physical therapy prescribed exercise in the past 3 months, current smokers, those with chronic widespread pain, those actively pursuing compensation, unable to work or with litigation pending or unable to communicate in English, persons who cannot tolerate 2 minutes of the cold pressor test (12 degrees Centigrade).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Numeric Pain Rating Scale (NPRS)

Timeframe: NPRS was taken at baseline- on the day of the data collection and prior to receiving the intervention. Follow-up NPRS were collected at: 2 days, 2 weeks and 4 weeks after baseline (baseline= is the date receiving the intervention)

Baseline Conditioned Pain Modulation

Timeframe: Before spinal/joint mobilization of the neck or cervical spine

Change in CPM (change in conditioned pain modulation)

Timeframe: Immediately after the intervention (spinal mobilization)

Trial details

NCT IDNCT07194603

SponsorAzusa Pacific University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-11

View on ClinicalTrials.gov More Neck Pain Musculoskeletal trials