Neck PainNCT06160648
The Comparative Effectiveness of Interventions in People With Neck Pain Who Exhibit Directional Preference
A study testing Management according to Mechanical Diagnosis and Therapy and Management according to the Cervical Spine Clinical Practice Guidelines in people with Neck Pain, run by Tufts University at 3 sites in United States.
Trial summary
The goal of this clinical trial is to compare physical therapy treatments in people with neck pain. The main aim is to compare the short-term effectiveness of physical therapy treatment for neck pain as delivered through Mechanical Diagnosis and Therapy (MDT) as compared to the Cervical Spine Clinical Practice… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Management according to Mechanical Diagnosis and Therapy and Management according to the Cervical Spine Clinical Practice Guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2024to 1 Jul 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are consecutively referred to physical therapy for the treatment of neck pain will be recruited from three hospital-based outpatient physical therapy clinics. Patients will be included if they demonstrate directional preference in the physical therapy initial examination.
- Patients aged 18-90 years
Who cannot join
- Patients will be excluded if they:
- Have a history of spinal surgery
- Have cervical instability, and/or vertebral basilar insufficiency
- Have a serious medical condition such as cancer, spondylolisthesis, rheumatoid arthritis, ankylosing spondylitis, or other related autoimmune diseases
- Are currently pregnant
- Are positive for upper motor neuron signs
- Are experiencing problems with dizziness, tinnitus, swallowing, or bowel and bladder dysfunction.
- Do not experience directional preference in the physical therapy initial examination.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Melissa Kolski, DPT, 312-238-7731, mkolski@sralab.org
Good Shepard Penn Partners
Radnor, Pennsylvania, 19087
Michael Post, DPT, 607-972-7026, Michael.Post@Pennmedicine.upenn.edu
WellSpan Health
York, Pennsylvania, 17403-3676
Brian McClenahan, MS PT, 908-601-2025, bmcclen@gmail.com
About this study
Official title: The Comparative Effectiveness of Mechanical Diagnosis and Therapy and Management According to the Cervical Spine Clinical Practice Guidelines in People With Neck Pain Who Exhibit Directional Preference: A Randomized Clinical Trial
The goal of this clinical trial is to compare physical therapy treatments in people with neck pain. The main aim is to compare the short-term effectiveness of physical therapy treatment for neck pain as delivered through Mechanical Diagnosis and Therapy (MDT) as compared to the Cervical Spine Clinical Practice Guidelines (CPGs) in patients with neck pain.
Participants will be randomly allocated to receive treatment according to MDT or CPG guidelines. Researchers will compare outcomes between the two groups over 1 year.
Read the detailed description
Neck pain is one of the leading musculoskeletal causes of disability, second only to low back pain. A growing number of individuals with spine pathologies are seeking medical care; however, the overall increase in costs for spinal conditions is largely due to the growing cost per individual. The age-standardized rates of incidence, prevalence, and years lived with neck pain in North America are higher when compared globally. Due to these high rates and increases in medical care for individuals with spinal pathologies, further research is essential in developing the most efficacious treatment approach. Current evidence-based interventions to address musculoskeletal conditions of the neck are summarized in the 2017 revision of the Neck Pain Clinical Practice Guidelines (CPGs). The most recent revision includes 4 categories of neck pain: neck pain with mobility deficits, neck pain with headaches, neck pain with radiating pain, and neck pain with movement coordination impairment. These categories differ from the McKenzie Method of Mechanical Diagnosis and Therapy (known clinically as MDT) classifications of Derangement Syndrome, Dysfunction Syndrome, Postural Syndrome, and Spinal other Subgroups. Neck pain is one of the leading musculoskeletal causes of disability, second only to low back pain. A growing number of individuals with spine pathologies are seeking medical care; however, the overall increase in costs for spinal conditions is largely due to the growing cost per individual. The age-standardized rates of incidence, prevalence, and years lived with neck pain in North America are higher when compared globally. Due to these high rates and increases in medical care for individuals with spinal pathologies, further research is essential in developing the most efficacious treatment approach. Current evidence-based interventions to address musculoskeletal conditions of the neck are summarized in the 2017 revision of the Neck Pain Clinical Practice Guidelines (CPGs). The most recent revision includes 4 categories of neck pain: neck pain with mobility deficits, neck pain with headaches, neck pain with radiating pain, and neck pain with movement coordination impairment. These categories differ from the McKenzie Method of Mechanical Diagnosis and Therapy (known clinically as MDT) classifications of Derangement Syndrome, Dysfunction Syndrome, Postural Syndrome, and Spinal other Subgroups. The primary aim of this study is to compare outcomes in people treated according to MDT or the CPGs.
- Conditions
- Neck Pain
- Being tested
- Management according to Mechanical Diagnosis and Therapy, Management according to the Cervical Spine Clinical Practice Guidelines
- Keywords
- Neck pain, Mechanical Diagnosis and Therapy, Clinical Practice Guidelines
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management according to Mechanical Diagnosis and TherapyOther
MDT management is based on the patient response to repeated end range movements.
Management according to the Cervical Spine Clinical Practice GuidelinesOther
CPG management is based on clinical research regarding management of people with neck pain.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Diagnosis and Therapy (MDT) | Experimental | MDT is a system of examination and intervention based on the patient's response to repeated end range neck movements. Receives: Other: Management according to Mechanical Diagnosis and Therapy |
| Cervical Spine Clinical Practice Guidelines (CPGs) | Active comparator | The CPGs are guidelines for examination and intervention based on a summary of research conducted on people with neck pain. Receives: Other: Management according to the Cervical Spine Clinical Practice Guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index (NDI)
The NDI is an outcome tool used to measure patient's perceived level of function in relation to their neck pain.
Measured: 1 year
Secondary outcomes (4)
Fear Avoidance Belief Questionnaire (FABQ)
The FABQ is an outcome tool used to measure a patient's fear in relation to their neck pain.
Measured: 1 year
Numerical Pain Rating Scale (NPRS)
The NPRS is a tool used to measure the patient's perception of the neck pain on a scale ranging from 0-10 with 10 representing the worst pain possible.
Measured: 1 year
Patient Specific Functional Scale (PSFS)
The PSFS is an outcome tool used to assess which particular functional activities are most impacted by their pain.
Measured: 1 year
Global Rating of Change Scale (GROC)
The GROC is an outcome tool used independently to measure improvements in a patient's condition or as an anchor for other outcome measures.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- 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
- Model description
- Participants are randomly allocated to one of two treatment groups.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Schenk, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160648
- Sponsor's protocol ID
- STUDY00002750
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Effectiveness of Mechanical Diagnosis and Therapy and Management According to the Cervical Spine Clinical Practice Guidelines in People With Neck Pain Who Exhibit Directional Preference: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06160648
- Acronym / sponsor ID
- STUDY00002750
- Conditions
- Neck Pain
- Keywords
- Neck pain, Mechanical Diagnosis and Therapy, Clinical Practice Guidelines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 7 Dec 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.
The goal of this clinical trial is to compare physical therapy treatments in people with neck pain. The main aim is to compare the short-term effectiveness of physical therapy treatment for neck pain as delivered through Mechanical Diagnosis and Therapy (MDT) as compared to the Cervical Spine Clinical Practice Guidelines (CPGs) in patients with neck pain.
Participants will be randomly allocated to receive treatment according to MDT or CPG guidelines. Researchers will compare outcomes between the two groups over 1 year.
Detailed description
Neck pain is one of the leading musculoskeletal causes of disability, second only to low back pain. A growing number of individuals with spine pathologies are seeking medical care; however, the overall increase in costs for spinal conditions is largely due to the growing cost per individual. The age-standardized rates of incidence, prevalence, and years lived with neck pain in North America are higher when compared globally. Due to these high rates and increases in medical care for individuals with spinal pathologies, further research is essential in developing the most efficacious treatment approach. Current evidence-based interventions to address musculoskeletal conditions of the neck are summarized in the 2017 revision of the Neck Pain Clinical Practice Guidelines (CPGs). The most recent revision includes 4 categories of neck pain: neck pain with mobility deficits, neck pain with headaches, neck pain with radiating pain, and neck pain with movement coordination impairment. These categories differ from the McKenzie Method of Mechanical Diagnosis and Therapy (known clinically as MDT) classifications of Derangement Syndrome, Dysfunction Syndrome, Postural Syndrome, and Spinal other Subgroups. Neck pain is one of the leading musculoskeletal causes of disability, second only to low back pain. A growing number of individuals with spine pathologies are seeking medical care; however, the overall increase in costs for spinal conditions is largely due to the growing cost per individual. The age-standardized rates of incidence, prevalence, and years lived with neck pain in North America are higher when compared globally. Due to these high rates and increases in medical care for individuals with spinal pathologies, further research is essential in developing the most efficacious treatment approach. Current evidence-based interventions to address musculoskeletal conditions of the neck are summarized in the 2017 revision of the Neck Pain Clinical Practice Guidelines (CPGs). The most recent revision includes 4 categories of neck pain: neck pain with mobility deficits, neck pain with headaches, neck pain with radiating pain, and neck pain with movement coordination impairment. These categories differ from the McKenzie Method of Mechanical Diagnosis and Therapy (known clinically as MDT) classifications of Derangement Syndrome, Dysfunction Syndrome, Postural Syndrome, and Spinal other Subgroups. The primary aim of this study is to compare outcomes in people treated according to MDT or the CPGs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly allocated to one of two treatment groups.
| Arm | Type | Receives |
|---|---|---|
| Mechanical Diagnosis and Therapy (MDT) | Experimental | Other: Management according to Mechanical Diagnosis and TherapyMDT is a system of examination and intervention based on the patient's response to repeated end range neck movements. |
| Cervical Spine Clinical Practice Guidelines (CPGs) | Active comparator | Other: Management according to the Cervical Spine Clinical Practice GuidelinesThe CPGs are guidelines for examination and intervention based on a summary of research conducted on people with neck pain. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are consecutively referred to physical therapy for the treatment of neck pain will be recruited from three hospital-based outpatient physical therapy clinics. Patients will be included if they demonstrate directional preference in the physical therapy initial examination.
- Patients aged 18-90 years
Key exclusion criteria (8 listed)
- Have a history of spinal surgery
- Have cervical instability, and/or vertebral basilar insufficiency
- Have a serious medical condition such as cancer, spondylolisthesis, rheumatoid arthritis, ankylosing spondylitis, or other related autoimmune diseases
- Are currently pregnant
- Are positive for upper motor neuron signs
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 |
|---|---|---|
| Management according to Mechanical Diagnosis and TherapyMDT management is based on the patient response to repeated end range movements. | Other | Mechanical Diagnosis and Therapy (MDT) |
| Management according to the Cervical Spine Clinical Practice GuidelinesCPG management is based on clinical research regarding management of people with neck pain. | Other | Cervical Spine Clinical Practice Guidelines (CPGs) |
Primary outcome
Neck Disability Index (NDI)
Time frame: 1 year
The NDI is an outcome tool used to measure patient's perceived level of function in relation to their neck pain.
4 secondary outcomes
Fear Avoidance Belief Questionnaire (FABQ)
Time frame: 1 year
Numerical Pain Rating Scale (NPRS)
Time frame: 1 year
Patient Specific Functional Scale (PSFS)
Time frame: 1 year
Global Rating of Change Scale (GROC)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Management according to Mechanical Diagnosis and Therapy and Management according to the Cervical Spine Clinical Practice Guidelines in people with Neck Pain, run by Tufts University at 3 sites 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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronald Schenk, PhD (716-566-8756, ronald.schenk@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (NDI) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.