Clinical trial NCT05940012: Specific and Shared Mechanisms Associated With Treatment for Chronic Neck Pain
Official title: Specific and Shared Mechanisms Associated With Physical Therapy Interventions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Neck Pain
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Saint-Joseph University
name: The Medical University of South Carolina
name: University of Colorado, Denver
First posted: 2023-07-11
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is expected that different physical therapy treatments influence outcomes in many different ways. Each treatment is assumed to have a "specific" treatment mechanism, which explains how that specific treatment works. Different treatments also have "shared" mechanisms, which are similar across many different types of interventions (e.g., exercise, cognitive treatments or manual therapy). In this study, the study team will investigate the several types of specific treatment mechanisms of a manual therapy-based approach and an exercise-based approach and the study team will compare these to see if they are different. The patient population will include individuals with chronic neck pain, which is a condition that leads to notable disability and pain. The study team will also evaluate several shared treatment mechanisms to see if these are similar across the two treatments (e.g., manual therapy versus exercise). The study team expects to find that there are some specific treatment mechanisms with each approach (manual therapy versus exercise) but also several "shared" mechanisms that are similar across the two seemingly different approaches. These will likely influence the outcomes and may help explain why clinicians see similar outcomes across both treatment groups for chronic neck pain. This study is important because no one has investigated whether the outcomes that occur with chronic neck pain are mostly influenced by specific or shared treatment mechanisms. Interestingly, in the psychological literature, shared treatment mechanisms demonstrate the strongest influence (more than specific treatment mechanisms).

Detailed description: Treatment mechanisms involve the steps or processes through which an intervention unfolds and produces the change in an outcome variable. In other words, a treatment mechanism is "how a treatment works". Treatment mechanisms can be specific to the intervention provided (i.e., fiber size increase and neuro adaptation occur with resistance exercise) or shared with other treatments (i.e., theoretically, increased therapeutic alliance and reduced fear of movement occur with almost all forms of interventions). In this proposal, the study team plans to investigate specific and shared treatment mechanisms of a manual therapy approach and a resistance exercise approach for treatment of chronic neck pain. The study team is targeting chronic neck pain because it is a common problem that is second only to low back pain for years lived with disability. Routinely, chronic neck pain management includes manual therapy and resistance exercise, as both approaches are included in clinical practice guidelines. The study plans to answer two research questions: 1) what are the specific mechanisms associated with manual therapy and resistance exercise interventions (and are these different), and 2) what are the shared mechanisms associated with these interventions, and do both mechanisms mediate clinical outcomes? The study team hypothesized that manual therapy and resistance exercise approaches will exhibit different specific treatment mechanisms. Further, the team hypothesizes that both approaches will lead to shared treatment mechanisms, which will notably influence outcomes at both 4 weeks and 6-month follow-up. This study is important because it will help identify how different treatment mechanisms influence clinical outcomes. There are several studies in the psychological literature that demonstrate the role of both specific and shared treatment mechanisms but this form of investigation is mostly absent for general musculoskeletal rehabilitation interventions. It will be the first study involving manual therapy in which specific and shared mechanisms are evaluated and explored against clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* Individuals with chronic neck pain (chronic pain is defined using the International Association of the Study of Pain (IASP) pragmatic criteria of pain lasting for 3 months or more that cannot be attributed to another diagnosis or condition.)
* 18 years of age and older
* experience ongoing neck pain of ≥3 on a 10-point scale for most days of the previous 3-months.

Exclusion Criteria:

* Individuals with cervical pain and suspected radicular symptoms
* a history of neck surgery within 1 year
* current or suspected red flags
* unable to speak or write in English.

Primary outcomes:
measure: Changes in Cervical Range of motion device (CROM) in flexion using a CROM
timeFrame: Baseline, 2 weeks, and 3 weeks
measure: Changes in Cervical Range of motion device in extension using a CROM
timeFrame: Baseline, 2 weeks, and 3 weeks
measure: Changes in Cervical Range of motion device rotation using a CROM
timeFrame: Baseline, 2 weeks, and 3 weeks
measure: Changes in Cervical Range of motion device in side flexion using a CROM
timeFrame: Baseline, 2 weeks, and 3 weeks
measure: Changes in Pain Pressure Threshold with Algometry
timeFrame: Baseline, 2 weeks, and 3 weeks
measure: Changes in time held with the Deep Neck Flexor Endurance Test
timeFrame: Baseline, 2 weeks, and 3 weeks
measure: Changes in in time held with the Cervical Extensor Endurance Test
timeFrame: Baseline, 2 weeks, and 3 weeks
measure: Changes in in time held with the Lateral Neck Flexor Endurance Test for left side
timeFrame: Baseline, 2 weeks, and 3 weeks
measure: Changes in in time held with the Lateral Neck Flexor Endurance Test for right side
timeFrame: Baseline, 2 weeks, and 3 weeks
Secondary outcomes:
measure: Change in the Working Alliance Inventory (WAI).
timeFrame: Baseline, 2 weeks and 3 weeks
measure: Change in the the OSPRO-YF-10
timeFrame: Baseline, 2 weeks and 3 weeks
measure: Change in the University of Washington Pain-Related Self Efficacy Scale short form
timeFrame: Baseline, 2 weeks and 3 weeks
measure: Change in Patient Health Engagement Scale
timeFrame: Baseline, 2 weeks and 3 weeks
measure: Change in the PROMIS 29.2.
timeFrame: Baseline, 4 weeks, and 6 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: The Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Duke University
name: Chad E Cook
role: PRINCIPAL_INVESTIGATOR
References: