Neck PainPhase 1NCT00504686
Patients With Neck Pain Likely to Benefit From Thoracic Spine Thrust Mobilization
A Phase 1 study testing manual therapy and exercise in people with Neck Pain, run by Franklin Pierce University at 1 site in United States.
Trial summary
Recently a clinical prediction rule (CPR) has been developed that identifies patients with neck pain who are likely to respond rapidly and dramatically to thoracic spine thrust manipulation and an active range of motion exercise. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- manual therapy and exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2008
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The following inclusion criteria will be used to determine eligibility for this study:
- Primary complaint of neck pain with or without unilateral upper extremity symptoms
- Age between 18-60 years old
- NDI score greater than 10 points
Who cannot join
- The following exclusion criteria will be used to determine ineligibility for this study:
- Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
- History of whiplash injury within the past six weeks
- Diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms
- Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
- Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
Show all 9Show fewer
- Muscle weakness involving a major muscle group of the upper extremity
- Diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps reflex)
- Diminished or absent sensation to pinprick in any upper extremity dermatome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Thoracic Spine Thrust Mobilization: A Randomized Clinical Trial
Recently a clinical prediction rule (CPR) has been developed that identifies patients with neck pain who are likely to respond rapidly and dramatically to thoracic spine thrust manipulation and an active range of motion exercise. Although the initial predictor variables identified during the development of a thoracic spine manipulation CPR seem to have adequate face validity, there is no guarantee that these factors will persist in a different group of patients, even ones with similar characteristics as those used in the initial exploratory study. The purpose of this follow-up study in which patients will be randomly assigned to receive thoracic spine thrust manipulation followed by therapeutic exercises or therapeutic exercise alone will be to investigate the validity of the previously developed CPR. If the CPR is indeed meaningful, patients who are positive on the CPR and receive thoracic spine thrust manipulation should experience improved outcomes compared to patients who are negative on the CPR and receive thoracic spine manipulation, and compared to patients who are positive on the CPR but receive the intervention believed to be effective for another subgroup of patients with neck pain.
Read the detailed description
Background: Recently a clinical prediction rule (CPR) has been developed that identifies patients with neck pain who are likely to respond rapidly and dramatically to thoracic spine thrust manipulation and an active range of motion exercise. Although the initial predictor variables identified during the development of a thoracic spine manipulation CPR seem to have adequate face validity, there is no guarantee that these factors will persist in a different group of patients, even ones with similar characteristics as those used in the initial exploratory study.
Purpose: The purpose of this follow-up study in which patients will be randomly assigned to receive thoracic spine thrust manipulation followed by therapeutic exercises or therapeutic exercise alone will be to investigate the validity of the previously developed CPR. If the CPR is indeed meaningful, patients who are positive on the CPR and receive thoracic spine thrust manipulation should experience improved outcomes compared to patients who are negative on the CPR and receive thoracic spine manipulation, and compared to patients who are positive on the CPR but receive the intervention believed to be effective for another subgroup of patients with neck pain.
Design: We will conduct a multi-center randomized clinical trial to assess the effectiveness of a previously-developed CPR for identifying patients with neck pain likely to respond to a thoracic spine thrust manipulation. Subjects between the ages of 18 and 60 with a primary report of neck pain will be randomized to receive manipulation plus an exercise program or to receive an exercise program only.
Methods: One hundred and forty patients with a primary complaint of neck pain who meet the inclusion/exclusion criteria and consent to participate will be enrolled in the study. We based sample size calculations on detecting a statistically significant difference between any of the 4 cells of the study which include the patients status on the rule (patients that meet the CPR and patients that do not meet the CPR) and treatment group (manipulation and exercise) by using the 1-week Neck Disability Index (NDI) score at an alpha-level of 0.05. To detect a 10 point change in NDI, with an expected standard deviation of 12 points at the 1 week follow up (effect size 0.80) with 90% power using a two-tailed hypothesis and assuming a 50% distribution of patients who do and do not meet the rule, 31 patients per cell are required. We will recruit 140 subjects into the study to control for drop-outs prior to the 1 and 4 week follow-up and possible distribution discrepancies between the classifications. The primary outcome point is four-weeks after randomization, with change in disability as measured by the NDI, serving as the primary outcome measure.
Data Analysis: We will examine the primary aim with a 3-way repeated-measures analysis of variance (ANOVA) with treatment group (manipulation vs. exercise) and status on the rule (positive or negative) as the between subjects independent variables and time (baseline, 1 week and 4 weeks) as the within-subjects independent variable. The dependent variable will be disability (NDI score). The hypothesis of interest is the 3-way group * CPR status * time interaction. We will perform planned pairwise comparisons at each follow-up period by using the Bonferroni inequality.
Significance: The results of this study should improve clinical decision-making and outcomes from physical therapy intervention by assisting clinicians in their ability to select appropriate manual physical therapy techniques for patients with neck pain. Validation of the CPR would enhance the certainty in which therapists will be able to identify patients with neck pain who are likely to exhibit a dramatic response to thoracic spine thrust manipulation as measured by reduced levels of disability) and therapeutic exercises. Results of the study will impact future patients with neck pain as it will provide a method of classification in which based on their clinical presentation therapists can determine the likelihood that they will or will not respond to thoracic spine thrust manipulation.
- Conditions
- Neck Pain
- Being tested
- manual therapy, exercise
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual therapyOther
manual therapy - thoracic spine thrust manipulation
exerciseOther
therapeutic exercise
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | manual therapy - thoracic spine thrust manipulation Receives: Other: manual therapy; Other: exercise |
| 2 | Active comparator | therapeutic exercise Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Measured: 4 weeks, 6 months
Secondary outcomes (1)
Pain
Measured: 4 week, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startJan 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Franklin Pierce University
- Sponsor type
- University, hospital or other
- Collaborators
- Newton-Wellesley Hospital
- Investigators
- Joshua A Cleland, PT, PhD, Principal investigator, Franklin Pierce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504686
- Sponsor's protocol ID
- HIC 06-14
- Status last verified
- Feb 2009
- First submitted
- 18 Jul 2007
- Last updated
- 3 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Cleland JA, Mintken PE, Carpenter K, Fritz JM, Glynn P, Whitman J, Childs JD. Examination of a clinical prediction rule to identify patients with neck pain likely to benefit from thoracic spine thrust manipulation and a general cervical range of motion exercise: multi-center randomized clinical trial. Phys Ther. 2010 Sep;90(9):1239-50. doi: 10.2522/ptj.20100123. Epub 2010 Jul 15.
PubMed 20634268
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Thoracic Spine Thrust Mobilization: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00504686
- Acronym / sponsor ID
- HIC 06-14
- Conditions
- Neck Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Franklin Pierce UniversityUniversity, hospital or other
- Collaborators
- Newton-Wellesley Hospital
- Study start
- Jan 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Jul 2007 (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.
Recently a clinical prediction rule (CPR) has been developed that identifies patients with neck pain who are likely to respond rapidly and dramatically to thoracic spine thrust manipulation and an active range of motion exercise. Although the initial predictor variables identified during the development of a thoracic spine manipulation CPR seem to have adequate face validity, there is no guarantee that these factors will persist in a different group of patients, even ones with similar characteristics as those used in the initial exploratory study. The purpose of this follow-up study in which patients will be randomly assigned to receive thoracic spine thrust manipulation followed by therapeutic exercises or therapeutic exercise alone will be to investigate the validity of the previously developed CPR. If the CPR is indeed meaningful, patients who are positive on the CPR and receive thoracic spine thrust manipulation should experience improved outcomes compared to patients who are negative on the CPR and receive thoracic spine manipulation, and compared to patients who are positive on the CPR but receive the intervention believed to be effective for another subgroup of patients with neck pain.
Detailed description
Background: Recently a clinical prediction rule (CPR) has been developed that identifies patients with neck pain who are likely to respond rapidly and dramatically to thoracic spine thrust manipulation and an active range of motion exercise. Although the initial predictor variables identified during the development of a thoracic spine manipulation CPR seem to have adequate face validity, there is no guarantee that these factors will persist in a different group of patients, even ones with similar characteristics as those used in the initial exploratory study.
Purpose: The purpose of this follow-up study in which patients will be randomly assigned to receive thoracic spine thrust manipulation followed by therapeutic exercises or therapeutic exercise alone will be to investigate the validity of the previously developed CPR. If the CPR is indeed meaningful, patients who are positive on the CPR and receive thoracic spine thrust manipulation should experience improved outcomes compared to patients who are negative on the CPR and receive thoracic spine manipulation, and compared to patients who are positive on the CPR but receive the intervention believed to be effective for another subgroup of patients with neck pain.
Design: We will conduct a multi-center randomized clinical trial to assess the effectiveness of a previously-developed CPR for identifying patients with neck pain likely to respond to a thoracic spine thrust manipulation. Subjects between the ages of 18 and 60 with a primary report of neck pain will be randomized to receive manipulation plus an exercise program or to receive an exercise program only.
Methods: One hundred and forty patients with a primary complaint of neck pain who meet the inclusion/exclusion criteria and consent to participate will be enrolled in the study. We based sample size calculations on detecting a statistically significant difference between any of the 4 cells of the study which include the patients status on the rule (patients that meet the CPR and patients that do not meet the CPR) and treatment group (manipulation and exercise) by using the 1-week Neck Disability Index (NDI) score at an alpha-level of 0.05. To detect a 10 point change in NDI, with an expected standard deviation of 12 points at the 1 week follow up (effect size 0.80) with 90% power using a two-tailed hypothesis and assuming a 50% distribution of patients who do and do not meet the rule, 31 patients per cell are required. We will recruit 140 subjects into the study to control for drop-outs prior to the 1 and 4 week follow-up and possible distribution discrepancies between the classifications. The primary outcome point is four-weeks after randomization, with change in disability as measured by the NDI, serving as the primary outcome measure.
Data Analysis: We will examine the primary aim with a 3-way repeated-measures analysis of variance (ANOVA) with treatment group (manipulation vs. exercise) and status on the rule (positive or negative) as the between subjects independent variables and time (baseline, 1 week and 4 weeks) as the within-subjects independent variable. The dependent variable will be disability (NDI score). The hypothesis of interest is the 3-way group * CPR status * time interaction. We will perform planned pairwise comparisons at each follow-up period by using the Bonferroni inequality.
Significance: The results of this study should improve clinical decision-making and outcomes from physical therapy intervention by assisting clinicians in their ability to select appropriate manual physical therapy techniques for patients with neck pain. Validation of the CPR would enhance the certainty in which therapists will be able to identify patients with neck pain who are likely to exhibit a dramatic response to thoracic spine thrust manipulation as measured by reduced levels of disability) and therapeutic exercises. Results of the study will impact future patients with neck pain as it will provide a method of classification in which based on their clinical presentation therapists can determine the likelihood that they will or will not respond to thoracic spine thrust manipulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: manual therapy, Other: exercisemanual therapy - thoracic spine thrust manipulation |
| 2 | Active comparator | Other: exercisetherapeutic exercise |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primary complaint of neck pain with or without unilateral upper extremity symptoms
- Age between 18-60 years old
- NDI score greater than 10 points
Key exclusion criteria (9 listed)
- Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
- History of whiplash injury within the past six weeks
- Diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms
- Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
- Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
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 therapymanual therapy - thoracic spine thrust manipulation | Other | 1 |
| exercisetherapeutic exercise | Other | 1, 2 |
Primary outcome
Neck Disability Index
Time frame: 4 weeks, 6 months
1 secondary outcome
Pain
Time frame: 4 week, 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 3 Feb 2009.
- Derived from this study: PubMed 20634268Cleland JA, Mintken PE, Carpenter K, Fritz JM, Glynn P, Whitman J, Childs JD. Examination of a clinical prediction rule to identify patients with neck pain likely to benefit from thoracic spine thrust manipulation and a general cervical range of motion exercise: multi-center randomized clinical trial. Phys Ther. 2010 Sep;90(9):1239-50. doi: 10.2522/ptj.20100123. Epub 2010 Jul 15.
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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.
Joshua A Cleland, PT, PhD principal investigator
Franklin Pierce University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing manual therapy and exercise in people with Neck Pain, run by Franklin Pierce 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 4 inclusion and 9 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 3 Feb 2009. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Neck Disability Index (time frame: 4 weeks, 6 months). 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 NCT00504686, which also lists 1 linked publication.
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 3 Feb 2009.