Chronic Neck PainSS-MECHNCT05940012
Specific and Shared Mechanisms Associated With Treatment for Chronic Neck Pain
A study testing Manual Therapy in people with Chronic Neck Pain, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 22 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Medical University of South Carolina
Charleston, South Carolina, 29424
About this study
Official title: Specific and Shared Mechanisms Associated With Physical Therapy Interventions
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).
Read the 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
- Being tested
- Manual Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyOther
Also called Force based manipulations
Hands on treatments including manipulation, mobilization and soft-tissue mobilization with therapeutic intent.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cervical Range of motion device (CROM) in flexion using a CROM
Measured: Baseline, 2 weeks, and 3 weeks
Changes in Cervical Range of motion device in extension using a CROM
Measured: Baseline, 2 weeks, and 3 weeks
Changes in Cervical Range of motion device rotation using a CROM
Measured: Baseline, 2 weeks, and 3 weeks
Changes in Cervical Range of motion device in side flexion using a CROM
Measured: Baseline, 2 weeks, and 3 weeks
Changes in Pain Pressure Threshold with Algometry
Measured: Baseline, 2 weeks, and 3 weeks
Changes in time held with the Deep Neck Flexor Endurance Test
Measured: Baseline, 2 weeks, and 3 weeks
Changes in in time held with the Cervical Extensor Endurance Test
Measured: Baseline, 2 weeks, and 3 weeks
Changes in in time held with the Lateral Neck Flexor Endurance Test for left side
Measured: Baseline, 2 weeks, and 3 weeks
Changes in in time held with the Lateral Neck Flexor Endurance Test for right side
Measured: Baseline, 2 weeks, and 3 weeks
Secondary outcomes (5)
Change in the Working Alliance Inventory (WAI).
The WAI evaluates the collaborative relationship between the helper and the client, but does not encompass all aspects of the therapy relationship (i.e. clinical outcomes, recidivism).The WAI is a 36 item scale with 3 domains (task, goal and bond). Each item is scored 1 to 7, with higher scores reflecting better alliance with the therapist. Total scores range from 36 (low alliance) to 252 (higher alliance). Higher scores are better.
Measured: Baseline, 2 weeks and 3 weeks
Change in the the OSPRO-YF-10
The OSPRO-YF is a 10 item Optimal Screening for Prediction of Referral and Outcome cohort yellow flag assessment tool. As OSPRO-YF summarizes 11 psychological questionnaires, it is not scored like a conventional screening tool. Quartile scores are used instead of cutoff scores for consistency and assessment of a wide range of outpatient orthopedic patients. Scores that are in the top quartile (top 25%) for negative psychological questionnaires (Negative Mood and Fear Avoidance questionnaires). Scores that are in the bottom quartile (bottom 25%) for positive psychological questionnaires (Positive Affect/Coping questionnaires).
Measured: Baseline, 2 weeks and 3 weeks
Change in the University of Washington Pain-Related Self Efficacy Scale short form
The UW Pain Related Self-Efficacy Scale is intended for measuring disability management self-efficacy in adults with chronic health conditions. The 6 items on the short form are summed using the values provided for each response available in the clinician/researcher version of the form. This will give a summary score that ranges from 6 to 30. Using the Summary Score to T-score Conversion Table, we will use the summary score to look up the IRT-based T-score in the column labeled "Tscore" in the conversion table (page 7 below). This T-score is the final score we will use for all analyses.
Measured: Baseline, 2 weeks and 3 weeks
Change in Patient Health Engagement Scale
The Patient Health Engagement Scale (PHE-s) is a patient self-administrable short psycho-metric questionnaire developed with the aim of diagnosing the level of patient engagement in their healthcare process that is function of his/her degree of emotional elaboration of the health condition. The scale has six items and each item is scored 1 to 7. A low score is poorer engagement whereas a higher score reflects higher engagement. Scores range from six to 42.
Measured: Baseline, 2 weeks and 3 weeks
Change in the PROMIS 29.2.
The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. Pain intensity is measured 0 to 10, with higher scores reflecting more pain. The other scales are measured as a t score, where 50% reflects the norm and value lower or higher reflect the current scoring by standard deviation to the general population.
Measured: Baseline, 4 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Jan 2024
- Primary completion30 Apr 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Saint-Joseph University, Medical University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Chad E Cook, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940012
- Sponsor's protocol ID
- PRO00113663
- Acronym
- SS-MECH
- Status last verified
- Nov 2024
- First submitted
- 26 May 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The proposal will follow the data sharing guidelines set forth for the NIH HEAL Initiative®. As with the HEAL initiative, we plan to create an infrastructure that addresses the need for researchers, clinicians, and patients to collaborate on sharing their collective data. Our Data Sharing Plan that (1) will make the two projected Publications Open Access and, to the extent possible, and (2) will make the Underlying Primary Data immediately and broadly available to the public. Underlying Primary Data should be made as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data.
Publications
Cook CE, O'Halloran B, Clewley D, Keefe F, McDevitt A. Specific and shared mechanisms associated with treatment for chronic neck pain: the SS-MECH mechanistic clinical trial. Pain Manag. 2026 Jun 8:1-9. doi: 10.1080/17581869.2026.2685609. Online ahead of print.
PubMed 42253014Cook CE, O'Halloran B, Clewley D, Keefe F, Green C, McDevitt A. Specific and shared mechanisms mediating pain intensity and functional outcomes in chronic neck pain. Pain Manag. 2026 Jul;16(7):799-808. doi: 10.1080/17581869.2026.2658063. Epub 2026 Apr 14.
PubMed 41979233
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific and Shared Mechanisms Associated With Physical Therapy Interventions
- ClinicalTrials.gov ID
- NCT05940012
- Acronym / sponsor ID
- SS-MECH / PRO00113663
- Conditions
- Chronic Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Saint-Joseph University, Medical University of South Carolina
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy treatment | Experimental | Other: Manual TherapyManual 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. |
| Resisted exercise treatment | Active comparator | Other: Manual TherapyIn-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual TherapyAlso: Force based manipulationsHands on treatments including manipulation, mobilization and soft-tissue mobilization with therapeutic intent. | Other | Manual therapy treatment, Resisted exercise treatment |
Primary outcome
Changes in Cervical Range of motion device (CROM) in flexion using a CROM
Time frame: Baseline, 2 weeks, and 3 weeks
Changes in Cervical Range of motion device in extension using a CROM
Time frame: Baseline, 2 weeks, and 3 weeks
Changes in Cervical Range of motion device rotation using a CROM
Time frame: Baseline, 2 weeks, and 3 weeks
Changes in Cervical Range of motion device in side flexion using a CROM
Time frame: Baseline, 2 weeks, and 3 weeks
Changes in Pain Pressure Threshold with Algometry
Time frame: Baseline, 2 weeks, and 3 weeks
Changes in time held with the Deep Neck Flexor Endurance Test
Time frame: Baseline, 2 weeks, and 3 weeks
Changes in in time held with the Cervical Extensor Endurance Test
Time frame: Baseline, 2 weeks, and 3 weeks
Changes in in time held with the Lateral Neck Flexor Endurance Test for left side
Time frame: Baseline, 2 weeks, and 3 weeks
Changes in in time held with the Lateral Neck Flexor Endurance Test for right side
Time frame: Baseline, 2 weeks, and 3 weeks
5 secondary outcomes
Change in the Working Alliance Inventory (WAI).
Time frame: Baseline, 2 weeks and 3 weeks
Change in the the OSPRO-YF-10
Time frame: Baseline, 2 weeks and 3 weeks
Change in the University of Washington Pain-Related Self Efficacy Scale short form
Time frame: Baseline, 2 weeks and 3 weeks
Change in Patient Health Engagement Scale
Time frame: Baseline, 2 weeks and 3 weeks
Change in the PROMIS 29.2.
Time frame: Baseline, 4 weeks, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Derived from this study: PubMed 42253014Cook CE, O'Halloran B, Clewley D, Keefe F, McDevitt A. Specific and shared mechanisms associated with treatment for chronic neck pain: the SS-MECH mechanistic clinical trial. Pain Manag. 2026 Jun 8:1-9. doi: 10.1080/17581869.2026.2685609. Online ahead of print.
- Derived from this study: PubMed 41979233Cook CE, O'Halloran B, Clewley D, Keefe F, Green C, McDevitt A. Specific and shared mechanisms mediating pain intensity and functional outcomes in chronic neck pain. Pain Manag. 2026 Jul;16(7):799-808. doi: 10.1080/17581869.2026.2658063. Epub 2026 Apr 14.
- Individual participant dataSharing planned: Yes. The proposal will follow the data sharing guidelines set forth for the NIH HEAL Initiative®. As with the HEAL initiative, we plan to create an infrastructure that addresses the need for researchers, clinicians, and patients to collaborate on sharing their collective data. Our Data Sharing Plan that (1) will make the two projected Publications Open Access and, to the extent possible, and (2) will make the Underlying Primary Data immediately and broadly available to the public. Underlying Primary Data should be made as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad E Cook principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy in people with Chronic Neck Pain, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Cervical Range of motion device (CROM) in flexion using a CROM (time frame: Baseline, 2 weeks, and 3 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05940012, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.