Neck PainNCT02619500
Thrust Manipulation vs. Non-thrust Mobilizations for Mechanical Neck Pain
A study testing Home Exercise Program, Patient advice, encouragement, and education and Thrust Manipulation in people with Neck Pain, run by Youngstown State University at 1 site in United States.
Trial summary
The purpose of this clinical trial is to compare the use of thrust manipulation to non-thrust mobilizations for mechanical neck pain when they are applied to both the cervical and thoracic spine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain
- What is being tested?
- Home Exercise Program, Patient advice, encouragement, and education and Thrust Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Nov 2017
- 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
- Chief complaint of neck pain. (Non-specific neck pain with a primary location between the superior nuchal line and the first thoracic spinous process)
- Age >18
- A minimum Neck Disability Index (NDI) score ≥ 20%
Who cannot join
- Contraindications to OMT including; malignancy, myelopathy, fracture, metabolic disease, rheumatoid arthritis, long-term corticosteroid use.
- Nerve root compression diagnosed as having at least 2 of the following:
- Upper extremity muscle weakness within a specific cervical/thoracic myotome
- Diminished deep tendon reflexes of the biceps brachii, brachioradialis, or triceps muscle.
- Diminished sensation to light touch or pinprick in a specific upper extremity dermatome.
- History of neck or thoracic spine surgery
Show all 10Show fewer
- Neck pain of <2 on the NPRS
- Currently receiving other forms of conservative care and unwilling to stop for the duration of their participation in the study.
- Any pending litigation related to their neck pain
- Therapist is unable to elicit the chief complaint with passive accessory intervertebral movements (PAIVM).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Youngstown state university
Youngstown, Ohio, 44406
David W Griswold, DPT, 330-701-5353, Dwgriswold@ysu.edu
Ken L Learman, PhD, 3302617376, Klearman@ysu.edu
About this study
Official title: A Pragmatically Applied Cervical and Thoracic Non-thrust Mobilizations Versus Thrust Manipulation for Patients With Mechanical Neck Pain: A Multicenter Randomized Clinical Trial
The purpose of this clinical trial is to compare the use of thrust manipulation to non-thrust mobilizations for mechanical neck pain when they are applied to both the cervical and thoracic spine. Both of these techniques have been compared in previous trials but a pragmatic approach will be employed as well as controlling for clinical equipoise.
Read the detailed description
A total sample size of 136 subjects with mechanical neck pain will be recruited to participant in this trial from multiple clinic and university sites around the country. Each subject will be evaluated by a licensed physical therapist that specializes in orthopedic manual therapy (OMT). Each treating therapist will be blinded be the data collection and each data collection therapist will be blinded to the treatment allocation. Subjects data will be collected at the initial visit, second visit, and at discharge. The maximum number of weeks that a subject may be enrolled is 8 weeks (2 months). At that point, they are discharged from the study. The treating therapist will allocate the subject through the already completed randomization procedures. Once the subject is randomized, the treating therapist will perform the OMT based on their clinical reasoning and in a manner they feel would benefit the patient the most. In addition to the OMT, each subject will receive a home exercise program, advice, encouragement, and education. A number of outcome variables will be collected regarded pain and disability as well as one physical performance measure.
- Conditions
- Neck Pain
- Being tested
- Home Exercise Program, Patient advice, encouragement, and education, Thrust Manipulation, Non-thrust Mobilizations
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Exercise ProgramOther
A standardized home exercise program will be given to subjects that will include active range of motion of the cervical and thoracic spine and deep cervical flexion endurance exercises.
Patient advice, encouragement, and educationOther
Therapists will provide each subject with advice and education pertaining to their condition as well as encouragement towards reducing pain and disability.
Thrust ManipulationOther
High velocity low amplitude (HVLA) thrust performed at or near the end range of a targeted segment in both the cervical and thoracic spine
Non-thrust MobilizationsOther
Repetitive and rhythmic accessory passive movements applied with either small or large amplitude at a targeted segment to both the cervical and thoracic spine
| Study group | Role | What they receive |
|---|---|---|
| Thrust Manipulation | Experimental | Subjects in this arm will receive spinal thrust manipulation to both the cervical and thoracic spines. Receives: Other: Home Exercise Program; Other: Patient advice, encouragement, and education; Other: Thrust Manipulation |
| Non-thrust Mobilizations | Active comparator | Subjects in this arm will receive spinal non-thrust mobilizations to both the cervical and thoracic spines Receives: Other: Home Exercise Program; Other: Patient advice, encouragement, and education; Other: Non-thrust Mobilizations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on the Neck Disability Index (NDI)
The NDI is a self-report measure of perceived disability and it is comprised of ten questions using an ordinal scale from 0 to 5 for a maximum of 50 points. The score is doubled to achieve a % score. The higher an individual scores on the NDI, the greater their perceived level of disability.
Measured: 3 days and 8 weeks
Secondary outcomes (4)
Change from baseline on The Patient Specific Functional Scale (PSFS)
The PSFS is a patient identified self-report questionnaire that measures general activity limitations. The scale ranges from 0 (unable to perform) to 10 (able to perform the activity at the level prior to injury). The patient reports three activities that are limited due to the current injury and an average rating for all three activities is calculated.
Measured: 3 days and 8 weeks
Change from baseline on The Numerical Pain Rating Scale (NPRS)
The NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Two separate pain ratings will be collected (current and average over a 24 hour period) experienced over 24 hours and then averaged for a composite score.
Measured: 3 days and 8 weeks
Change from baseline on The Global Rating Of Change Scale (GROC)
The GROC is a 15-point scale used to quantify a patient's improvement with treatment or to record the clinical course of a condition over time. Patients are asked to describe their overall condition since the start of treatment until the present time with options ranging from -7 ("a very great deal worse") to +7 ("a very great deal better") and 0 being described as "about the same."
Measured: 3 days and 8 weeks
Change from baseline on the Deep Cervical Flexion Endurance (DCF)
Patients are positioned in supine and will be instructed to maximally tuck his/her chin isometrically. Patients will then be instructed to lift their head 2.5 cm off the plinth and to maintain upper cervical flexion simultaneously for as long as they were able. A skin fold along the antero-lateral neck will be monitored and the investigator's hand will remain under the occiput of the patient for tactile cueing. The timing of the position began once the patient is in the correct position and stopped if; the patient's head drops into the fingers of the clinician, is elevated greater than one inch, the patient loses the skin fold on the antero-lateral neck, or the patient is unable to continue.
Measured: 3 days and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Youngstown State University
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Southeastern University
- Responsible party
- Principal investigator, David W. Griswold, Youngstown State University
- Investigators
- Josh Cleland, PhD, Study chair, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619500
- Sponsor's protocol ID
- 033-16
- Status last verified
- Feb 2016
- First submitted
- 24 Nov 2015
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Griswold D, Learman K, O'Halloran B, Cleland J. A preliminary study comparing the use of cervical/upper thoracic mobilization and manipulation for individuals with mechanical neck pain. J Man Manip Ther. 2015 May;23(2):75-83. doi: 10.1179/2042618614Y.0000000095.
PubMed 26109828Young JL, Walker D, Snyder S, Daly K. Thoracic manipulation versus mobilization in patients with mechanical neck pain: a systematic review. J Man Manip Ther. 2014 Aug;22(3):141-53. doi: 10.1179/2042618613Y.0000000043.
PubMed 25125936Dunning JR, Cleland JA, Waldrop MA, Arnot CF, Young IA, Turner M, Sigurdsson G. Upper cervical and upper thoracic thrust manipulation versus nonthrust mobilization in patients with mechanical neck pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):5-18. doi: 10.2519/jospt.2012.3894. Epub 2011 Sep 30.
PubMed 21979312Cook C, Learman K, Showalter C, Kabbaz V, O'Halloran B. Early use of thrust manipulation versus non-thrust manipulation: a randomized clinical trial. Man Ther. 2013 Jun;18(3):191-8. doi: 10.1016/j.math.2012.08.005. Epub 2012 Oct 2.
PubMed 23040656Griswold D, Learman K, Kolber MJ, O'Halloran B, Cleland JA. Pragmatically Applied Cervical and Thoracic Nonthrust Manipulation Versus Thrust Manipulation for Patients With Mechanical Neck Pain: A Multicenter Randomized Clinical Trial. J Orthop Sports Phys Ther. 2018 Mar;48(3):137-145. doi: 10.2519/jospt.2018.7738. Epub 2018 Feb 6.
PubMed 29406835
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatically Applied Cervical and Thoracic Non-thrust Mobilizations Versus Thrust Manipulation for Patients With Mechanical Neck Pain: A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02619500
- Acronym / sponsor ID
- 033-16
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Youngstown State UniversityUniversity, hospital or other
- Collaborators
- Nova Southeastern University
- Study start
- Feb 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 2 Dec 2015 (estimated)
- 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 purpose of this clinical trial is to compare the use of thrust manipulation to non-thrust mobilizations for mechanical neck pain when they are applied to both the cervical and thoracic spine. Both of these techniques have been compared in previous trials but a pragmatic approach will be employed as well as controlling for clinical equipoise.
Detailed description
A total sample size of 136 subjects with mechanical neck pain will be recruited to participant in this trial from multiple clinic and university sites around the country. Each subject will be evaluated by a licensed physical therapist that specializes in orthopedic manual therapy (OMT). Each treating therapist will be blinded be the data collection and each data collection therapist will be blinded to the treatment allocation. Subjects data will be collected at the initial visit, second visit, and at discharge. The maximum number of weeks that a subject may be enrolled is 8 weeks (2 months). At that point, they are discharged from the study. The treating therapist will allocate the subject through the already completed randomization procedures. Once the subject is randomized, the treating therapist will perform the OMT based on their clinical reasoning and in a manner they feel would benefit the patient the most. In addition to the OMT, each subject will receive a home exercise program, advice, encouragement, and education. A number of outcome variables will be collected regarded pain and disability as well as one physical performance measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrust Manipulation | Experimental | Other: Home Exercise Program, Other: Patient advice, encouragement, and education, Other: Thrust ManipulationSubjects in this arm will receive spinal thrust manipulation to both the cervical and thoracic spines. |
| Non-thrust Mobilizations | Active comparator | Other: Home Exercise Program, Other: Patient advice, encouragement, and education, Other: Non-thrust MobilizationsSubjects in this arm will receive spinal non-thrust mobilizations to both the cervical and thoracic spines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chief complaint of neck pain. (Non-specific neck pain with a primary location between the superior nuchal line and the first thoracic spinous process)
- Age >18
- A minimum Neck Disability Index (NDI) score ≥ 20%
Key exclusion criteria (10 listed)
- Contraindications to OMT including; malignancy, myelopathy, fracture, metabolic disease, rheumatoid arthritis, long-term corticosteroid use.
- Nerve root compression diagnosed as having at least 2 of the following:
- History of neck or thoracic spine surgery
- Neck pain of <2 on the NPRS
- Currently receiving other forms of conservative care and unwilling to stop for the duration of their participation in the study.
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 |
|---|---|---|
| Home Exercise ProgramA standardized home exercise program will be given to subjects that will include active range of motion of the cervical and thoracic spine and deep cervical flexion endurance exercises. | Other | Non-thrust Mobilizations, Thrust Manipulation |
| Patient advice, encouragement, and educationTherapists will provide each subject with advice and education pertaining to their condition as well as encouragement towards reducing pain and disability. | Other | Non-thrust Mobilizations, Thrust Manipulation |
| Thrust ManipulationHigh velocity low amplitude (HVLA) thrust performed at or near the end range of a targeted segment in both the cervical and thoracic spine | Other | Thrust Manipulation |
| Non-thrust MobilizationsRepetitive and rhythmic accessory passive movements applied with either small or large amplitude at a targeted segment to both the cervical and thoracic spine | Other | Non-thrust Mobilizations |
Primary outcome
Change from baseline on the Neck Disability Index (NDI)
Time frame: 3 days and 8 weeks
The NDI is a self-report measure of perceived disability and it is comprised of ten questions using an ordinal scale from 0 to 5 for a maximum of 50 points. The score is doubled to achieve a % score. The higher an individual scores on the NDI, the greater their perceived level of disability.
4 secondary outcomes
Change from baseline on The Patient Specific Functional Scale (PSFS)
Time frame: 3 days and 8 weeks
Change from baseline on The Numerical Pain Rating Scale (NPRS)
Time frame: 3 days and 8 weeks
Change from baseline on The Global Rating Of Change Scale (GROC)
Time frame: 3 days and 8 weeks
Change from baseline on the Deep Cervical Flexion Endurance (DCF)
Time frame: 3 days and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
- Background: PubMed 26109828Griswold D, Learman K, O'Halloran B, Cleland J. A preliminary study comparing the use of cervical/upper thoracic mobilization and manipulation for individuals with mechanical neck pain. J Man Manip Ther. 2015 May;23(2):75-83. doi: 10.1179/2042618614Y.0000000095.
- Background: PubMed 25125936Young JL, Walker D, Snyder S, Daly K. Thoracic manipulation versus mobilization in patients with mechanical neck pain: a systematic review. J Man Manip Ther. 2014 Aug;22(3):141-53. doi: 10.1179/2042618613Y.0000000043.
- Background: PubMed 21979312Dunning JR, Cleland JA, Waldrop MA, Arnot CF, Young IA, Turner M, Sigurdsson G. Upper cervical and upper thoracic thrust manipulation versus nonthrust mobilization in patients with mechanical neck pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):5-18. doi: 10.2519/jospt.2012.3894. Epub 2011 Sep 30.
- Background: PubMed 23040656Cook C, Learman K, Showalter C, Kabbaz V, O'Halloran B. Early use of thrust manipulation versus non-thrust manipulation: a randomized clinical trial. Man Ther. 2013 Jun;18(3):191-8. doi: 10.1016/j.math.2012.08.005. Epub 2012 Oct 2.
- Derived from this study: PubMed 29406835Griswold D, Learman K, Kolber MJ, O'Halloran B, Cleland JA. Pragmatically Applied Cervical and Thoracic Nonthrust Manipulation Versus Thrust Manipulation for Patients With Mechanical Neck Pain: A Multicenter Randomized Clinical Trial. J Orthop Sports Phys Ther. 2018 Mar;48(3):137-145. doi: 10.2519/jospt.2018.7738. Epub 2018 Feb 6.
Related trials for Neck Pain
Not yet recruiting
Comparison of the Effectiveness of Motor Imagery Exercises and Suboccipital Myofascial Release Techniques in Nonspecific Chronic Neck Pain
Non-specific Chronic Neck Pain
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Not yet recruiting
Comparative Effects of Dynamic Cupping and Facilitated Positional Release in Cervicogenic Headache
Cervicogenic Headache
Not yet recruiting
Effects of Cervical SNAGs With and Without Thoracic Manipulation on Neck Pain and Disability in Smartphone Users
Non Specific Neck Pain
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
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.
Josh Cleland, PhD study chair
Nova Southeastern 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 Home Exercise Program, Patient advice, encouragement, and education and Thrust Manipulation in people with Neck Pain, run by Youngstown State 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 10 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 12 Feb 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David W Griswold, DPT (330-941-2419, dwgriswold@ysu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on the Neck Disability Index (NDI) (time frame: 3 days and 8 weeks). 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 NCT02619500, which also lists 5 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 12 Feb 2016.