Specific and Shared Mechanisms Associated With Treatment for Chronic Neck Pain

NCT ID: NCT05940012

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-10-22

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.

Conditions

Chronic Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manual therapy treatment

Manual therapy treatments will consist of global soft tissue stretching of the upper trapezius, occipital muscles, levator scapula, and scalene muscles as the patient lies in supine. Non-thrust manipulation will consist of unilateral or central posterior-anterior accessory movements (PAIVMs) to the cervical and upper thoracic segments (in prone) at the most symptomatic levels. Passive physiological intervertebral movements of rotation will be performed in supine, as a mechanism to reduce pain and increase range of motion. Individuals with chronic neck pain randomized to the manual therapy arm, will be assigned a HEP twice daily that will consist of cervical rotations with belt or equivalent, side flexion with belt or equivalent, self-stretching exercises that are designed to target the upper thoracic musculature, and corner wall stretches.

Group Type: EXPERIMENTAL

Manual Therapy

Intervention Type: OTHER

Hands on treatments including manipulation, mobilization and soft-tissue mobilization with therapeutic intent.

Resisted exercise treatment

In-clinic exercises will consist of chin retractions in sitting, supine clock isometric resistance, supine anterior neck flexion exercises that target the deep neck flexors, prone neck extensor exercises (with concurrent chin retraction), and lateral neck raises (bilaterally). The study team will also target the mid and upper thoracic region by performing upright rows, supine chest raises that target the mid-scapular muscles and the paraspinal muscles, prone "I, T, and Y" exercises, and proprioceptive neuromuscular facilitation exercises using a bar or a cane. Individuals randomized to the resistance exercise arm will be assigned a HEP twice daily that will consist of chin retractions in sitting, supine anterior neck flexion exercises, and elastic band rows that replicate the upright rows performed in the clinic.

Group Type: ACTIVE_COMPARATOR

Manual Therapy

Intervention Type: OTHER

Hands on treatments including manipulation, mobilization and soft-tissue mobilization with therapeutic intent.

Interventions

Manual Therapy

Hands on treatments including manipulation, mobilization and soft-tissue mobilization with therapeutic intent.

Intervention Type: OTHER

Other Intervention Names

Force based manipulations

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint-Joseph University

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chad E Cook

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

The Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

PRO00113663

Identifier Type: -

Identifier Source: org_study_id