Specific and Shared Mechanisms Associated With Treatment for Chronic Neck Pain

NCT05940012 | Completed

• 1 other identifier: PRO00113663
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Neck Pain

Outcome Measures

Primary Outcomes (9)

• Changes in Cervical Range of motion device (CROM) in flexion using a CROM

  Baseline, 2 weeks, and 3 weeks

• Changes in Cervical Range of motion device in extension using a CROM

  Baseline, 2 weeks, and 3 weeks

• Changes in Cervical Range of motion device rotation using a CROM

  Baseline, 2 weeks, and 3 weeks

• Changes in Cervical Range of motion device in side flexion using a CROM

  Baseline, 2 weeks, and 3 weeks

• Changes in Pain Pressure Threshold with Algometry

  Baseline, 2 weeks, and 3 weeks

• Changes in time held with the Deep Neck Flexor Endurance Test

  Baseline, 2 weeks, and 3 weeks

• Changes in in time held with the Cervical Extensor Endurance Test

  Baseline, 2 weeks, and 3 weeks

• Changes in in time held with the Lateral Neck Flexor Endurance Test for left side

  Baseline, 2 weeks, and 3 weeks

• Changes in in time held with the Lateral Neck Flexor Endurance Test for right side

  Baseline, 2 weeks, and 3 weeks

Secondary Outcomes (5)

• Change in the Working Alliance Inventory (WAI).

  Baseline, 2 weeks and 3 weeks

• Change in the the OSPRO-YF-10

  Baseline, 2 weeks and 3 weeks

• Change in the University of Washington Pain-Related Self Efficacy Scale short form

  Baseline, 2 weeks and 3 weeks

• Change in Patient Health Engagement Scale

  Baseline, 2 weeks and 3 weeks

• Change in the PROMIS 29.2.

  Baseline, 4 weeks, and 6 months

Study Arms (2)

Manual therapy treatment

EXPERIMENTAL

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.

Other: Manual Therapy

Resisted exercise treatment

ACTIVE COMPARATOR

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.

Other: Manual Therapy

Interventions

Manual Therapy OTHER

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

Also known as: Force based manipulations

Manual therapy treatment; Resisted exercise treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)
• years of age and older
• experience ongoing neck pain of ≥3 on a 10-point scale for most days of the previous 3-months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Saint-Joseph University: collaborator
• Medical University of South Carolina: collaborator

Study Sites (1)

The Medical University of South Carolina

Charleston, South Carolina, 29424, United States

Location

MeSH Terms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Chad E Cook

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects are told they will be randomized into two forms of treatment for chronic neck pain and that the study team is interested in learning the mechanisms associated with that treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: July 11, 2023
• Study Start: January 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: October 22, 2025
• Last Updated: November 18, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Protocol when published. SAP within the protocol when published. Informed consent once approval of IRB.

Locations

US (1)