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

NCT07194603 | Completed

• 2 other identifiers: 25-141T42OH008422
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neck Pain Musculoskeletal; Chronic

Keywords

conditioned pain modulation; joint mobilization; spinal mobilization; chronic neck pain; pain pressure threshold; cold pressor test; numeric pain rating scale; neck disability index; global perceived recovery

Outcome Measures

Primary Outcomes (3)

• Numeric Pain Rating Scale (NPRS)

  The NPRS is a self-reported measure of the intensity of pain from 0 (no pain) to 10 (worst possible pain). It can be reported verbally (and has been validated for reporting by telephone), administered graphically on screen or on paper.

  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

  Measuring CPM involves three steps. In step one (test stimulus) a pressure algometer is applied randomly to 3 marked anatomical sites (i.e., symptomatic side of the neck at C3/4, infraspinatus of the shoulder and the anterior tibial muscle of the lower extremity to determine the pain pressure threshold or PPT). The pressure is applied to the patient until the pressure is first perceived as pain, and the pressure value is recorded. Step two (conditioning stimulus) is the cold pressor test or CPT, which involves placing the hand in a basin of cold water (12 degrees Centigrade) for 2 minutes. Step three (test stimulus) is a repeat of step one. CPM= \[PPT (step 3) minus PPT (step 1)\] divided by PPT (step 1) \* 100. The CPM is expressed as a %. CPM= (PPT (step 3)-PPT (step 1))/(PPT (step 1)) × 100 A positive number signifies a normal CPM. No change or a negative number indicates an abnormal CPM.

  Before spinal/joint mobilization of the neck or cervical spine

• Change in CPM (change in conditioned pain modulation)

  Change in CPM: is the difference between post-intervention (post-JM) CPM and baseline CPM. Post-JM CPM is assessed after spinal/joint mobilization of the neck or cervical spine using the same procedure as when the baseline CPM was assessed. Thus, Post-JM CPM minus baseline CPM= Change in CPM. How CPM is measured is described under "baseline CPM" above.

  Immediately after the intervention (spinal mobilization)

Secondary Outcomes (2)

• Global perceived recovery (GPR)

  GPR was taken at baseline- on the day of data collection and prior to receiving the intervention to determine patient expectation of recovery at 4-weeks. Follow-up GPR were collected at: 2 days, 2 weeks and 4 weeks after the date of the intervention.

• Neck Disability Index (NDI)

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

Study Arms (1)

Spinal/joint mobilization of the neck

EXPERIMENTAL

The principal investigator provided spinal mobilization (SM) of the neck consisting of grade III unilateral postero-anterior (PA) and antero-posterior (AP) oscillatory joint mobilization (JM) to the cervical spine \[5 minutes of PA and 5 minutes of AP in random order based on the random sequence for the CPM measurement\] for a total of 10 minutes to the patient's most painful cervical spine segment/s. Both SM and JM mean the same thing and are synonymous. Prior to SM, the PI explained why SM might work and advised participants to continue their usual activities of daily living.

Procedure: Spinal mobilization (SM) of the neck

Interventions

Spinal mobilization (SM) of the neck PROCEDURE

This cohort intervention study has only one arm and this arm has only one intervention, the one described above. Both SM and JM mean the same thing and are synonymous.

Spinal/joint mobilization of the neck

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Azusa Pacific University: lead
• Sacred Heart University: collaborator

Study Sites (1)

Azusa Pacific University

Azusa, California, 91702, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Emmanuel Yung, PT, DPT

  New York University (at the time of the study)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Everyone, including the outcome assessor, was blinded to what the conditioned pain modulation was for each participant throughout the data collection session. The researcher applying the algometer for the pain pressure threshold did not record the values, instead the outcomes assessor did this step. Although the outcome assessor recorded the pain pressure thresholds (PPTs) pre-/post-cold pressor test \[PPTs are used to calculate the conditioned pain modulation before AND after the intervention\], they did not calculate the conditioned pain modulation until the end of the data collection day when all the participants have left.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a cohort intervention study

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 26, 2025
• Study Start: June 21, 2021
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Start date: Upon publication of the original study in an indexed peer-reviewed journal once it is available in print. End date: one year from the start date
• Access Criteria: Anyone can access this data set.

Locations

US (1)