Neck PainPhase 2NCT00269360
Manipulation, Exercise, and Self-Care for Neck Pain
A Phase 2 study testing Chiropractic + Supervised Rehabilitative Exercise, Supervised Rehabilitative Exercise and Self-care education in people with Neck Pain, run by Northwestern Health Sciences University at 1 site in United States.
Trial summary
The purpose of this study is to compare three treatments for neck pain: 1) rehabilitative exercise, 2) chiropractic spinal manipulation combined with rehabilitative exercise, and 3) self-care education. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Chiropractic + Supervised Rehabilitative Exercise, Supervised Rehabilitative Exercise and Self-care education
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Feb 2005
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic mechanical neck pain (defined as current episode > 12 weeks' duration).
- Quebec Task Force classifications 1, 2, 3 and 4. This includes patients with neck pain, stiffness or tenderness, with or without musculoskeletal and neurological signs.
Who cannot join
- Previous cervical spine surgery
- Neck pain referred from local joint lesions of the lower extremities or from visceral diseases
- Progressive neurological deficits due to nerve root or spinal cord compression
- Existing cardiac disease requiring medical treatment
- Blood clotting disorders
- Diffuse idiopathic hyperostosis
Show all 13Show fewer
- Infectious and non-infectious inflammatory or destructive tissue changes of the cervical spine
- Presence of significant infectious disease, or other severe disabling health problems
- Substance abuse
- Ongoing treatment for neck pain by other health care providers
- Pregnant or nursing women
- Average neck pain score of less than 30 percentage points
- Pending or current litigation
Trial locations and contacts
1 site in 1 country.
United States1 site
Wolfe-Harris Center for Clinical Studies
Bloomington, Minnesota, 55431
About this study
The purpose of this study is to compare three treatments for neck pain: 1) rehabilitative exercise, 2) chiropractic spinal manipulation combined with rehabilitative exercise, and 3) self-care education.
Read the detailed description
Neck pain is very common, afflicting 10% of the population at any given time. Despite its significant socioeconomic impact, neck pain has been poorly investigated. The broad, long term objective of this interdisciplinary research is to identify effective therapies for neck pain and to increase our knowledge of this problematic condition. This multidisciplinary, randomized clinical trial is based on the investigators' previous neck pain research and will assess three treatment approaches for chronic neck pain:
- rehabilitative exercise
- chiropractic spinal manipulation combined with rehabilitative exercise
- self-care education (a minimal intervention control)
The primary aim of this study is to examine the relative efficacy of the three interventions in terms of patient-rated outcomes in the short term (after 12 weeks) and long term (after 52 weeks) for chronic neck pain. Secondary aims are to assess the relative cost-effectiveness and cost utility of the three treatments, evaluate changes in objective cervical spine function, assess if cervical function is associated with changes in patient-rated outcomes, identify predictors of outcome and finally, to describe patients' interpretations of outcome measures used in clinical trials.
Using previously demonstrated recruitment methods, 270 participants with chronic neck pain will be recruited. Self-reported outcome measures will be collected at baseline and 4, 12, 26 and 52 weeks; objective outcome measures will be assessed by blinded examiners at baseline and 12 weeks.
Chiropractic investigators from Northwestern Health Sciences University are collaborating with medical clinicians from the University of Minnesota, the Minneapolis Medical Research Foundation, and the Pain Assessment and Rehabilitation Center. This established team of investigators will work together in all phases of this innovative study, leading to dissemination and publication of study results and hypothesis generation for future research. This trial will yield important information allowing health care practitioners, policy makers and patients to make better-informed decisions regarding treatment choices for chronic neck pain. Importantly, it will serve to increase the extremely limited research that currently exists for this significant health-care condition.
- Conditions
- Neck Pain
- Being tested
- Chiropractic + Supervised Rehabilitative Exercise, Supervised Rehabilitative Exercise, Self-care education
- Keywords
- Chiropractic, Manual Therapies, Exercise, Randomized, Clinical Trial, Neck Pain
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic + Supervised Rehabilitative ExerciseProcedure or surgery
Chiropractic care will include manual spinal manipulation, with light soft tissue massage as indicated to facilitate the spinal manipulative therapy. The spinal levels treated will be determined by the individual chiropractors by static and/or motion palpation.
Patients will attend 20, 1 hour sessions of rehabilitative exercises for the neck and upper body. Each session will begin with a 10-minute aerobic warm-up of the upper body and five minutes of light stretching to prepare for the strengthening exercises.
Supervised Rehabilitative ExerciseProcedure or surgery
Patients will attend 20, 1 hour sessions of rehabilitative exercises for the neck and upper body. Each session will begin with a 10-minute aerobic warm-up of the upper body and five minutes of light stretching to prepare for the strengthening exercises.
Self-care educationBehavioural
Self-care education will be provided by the therapist trained in the study protocol. Two, one-hour sessions will be given regarding self-care measures and ergonomics relative to work and activities of daily living. These will include postural instructions and practical demonstrations of proper body mechanics performed with patient participation.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: Chiropractic + Supervised Rehabilitative Exercise |
| 2 | Experimental | Not described Receives: Procedure: Supervised Rehabilitative Exercise |
| 3 | Active comparator | Not described Receives: Behavioral: Self-care education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient rated pain(0-10 scale,11 box)
Measured: short term = 12 weeks; long term = 52 weeks
Secondary outcomes (14)
Neck Disability Index (NDI)at baseline, weeks 4,12,26,52
Measured: short term = 12 weeks; long term = 52 weeks
General health status at baseline, weeks 4,12,26,52
Measured: short term = 12 weeks; long term = 52 weeks
Improvement (Global Change)at baseline, weeks 4,12,26,52
Measured: short term = 12 weeks; long term = 52 weeks
Disability Days at baseline, weeks 4,12,26,52
Measured: short term = 12 weeks; long term = 52 weeks
Bothersomeness of Symptoms at baseline, weeks 4,12,26,52
Measured: short term = 12 weeks; long term = 52 weeks
Frequency of Symptoms at baseline, weeks 4,12,26,52
Measured: short term = 12 weeks; long term = 52 weeks
Patient Satisfaction at baseline, weeks 4,12,26,52
Measured: short term = 12 weeks; long term = 52 weeks
Depression at baseline, weeks 4,12,26,52
Measured: short term = 12 weeks; long term = 52 weeks
Medication use at baseline, weeks 4,12,26,52
Measured: short term = 12 weeks; long term = 52 weeks
Fear-Avoidance Beliefs at baseline, weeks 4,12,26,52
Measured: short term = 12 weeks; long term = 52 weeks
Cervical range of motion at baseline, weeks 4,12
Measured: short term = 12 weeks
Cervical Strength and Endurance at baseline, weeks 4,12
Measured: short term = 12 weeks
Health Care Costs and Utilization at weeks 4,12,26,52
Measured: short term = 12 weeks; long term = 52 weeks
In-depth Interview at week 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startMar 2001
- Study completionFeb 2005
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern Health Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), Berman Center for Outcomes and Clinical Research
- Investigators
- Gert Bronfort, DC, PhD, Principal investigator, Northwestern Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269360
- Sponsor's protocol ID
- R18HP10013
- Status last verified
- Nov 2007
- First submitted
- 21 Dec 2005
- Last updated
- 20 Nov 2007
- Results posted
- No
Publications
Evans R, Bronfort G, Schulz C, Maiers M, Bracha Y, Svendsen K, Grimm R, Garvey T, Transfeldt E. Supervised exercise with and without spinal manipulation performs similarly and better than home exercise for chronic neck pain: a randomized controlled trial. Spine (Phila Pa 1976). 2012 May 15;37(11):903-14. doi: 10.1097/BRS.0b013e31823b3bdf.
PubMed 22024905
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manipulation, Exercise, and Self-Care for Neck Pain
- ClinicalTrials.gov ID
- NCT00269360
- Acronym / sponsor ID
- R18HP10013
- Conditions
- Neck Pain
- Keywords
- Chiropractic, Manual Therapies, Exercise, Randomized, Clinical Trial, Neck Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Northwestern Health Sciences UniversityUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), Berman Center for Outcomes and Clinical Research
- Study start
- Mar 2001
- Study completion
- Feb 2005 (actual)
- First posted
- 23 Dec 2005 (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 study is to compare three treatments for neck pain: 1) rehabilitative exercise, 2) chiropractic spinal manipulation combined with rehabilitative exercise, and 3) self-care education.
Detailed description
Neck pain is very common, afflicting 10% of the population at any given time. Despite its significant socioeconomic impact, neck pain has been poorly investigated. The broad, long term objective of this interdisciplinary research is to identify effective therapies for neck pain and to increase our knowledge of this problematic condition. This multidisciplinary, randomized clinical trial is based on the investigators' previous neck pain research and will assess three treatment approaches for chronic neck pain:
- rehabilitative exercise
- chiropractic spinal manipulation combined with rehabilitative exercise
- self-care education (a minimal intervention control)
The primary aim of this study is to examine the relative efficacy of the three interventions in terms of patient-rated outcomes in the short term (after 12 weeks) and long term (after 52 weeks) for chronic neck pain. Secondary aims are to assess the relative cost-effectiveness and cost utility of the three treatments, evaluate changes in objective cervical spine function, assess if cervical function is associated with changes in patient-rated outcomes, identify predictors of outcome and finally, to describe patients' interpretations of outcome measures used in clinical trials.
Using previously demonstrated recruitment methods, 270 participants with chronic neck pain will be recruited. Self-reported outcome measures will be collected at baseline and 4, 12, 26 and 52 weeks; objective outcome measures will be assessed by blinded examiners at baseline and 12 weeks.
Chiropractic investigators from Northwestern Health Sciences University are collaborating with medical clinicians from the University of Minnesota, the Minneapolis Medical Research Foundation, and the Pain Assessment and Rehabilitation Center. This established team of investigators will work together in all phases of this innovative study, leading to dissemination and publication of study results and hypothesis generation for future research. This trial will yield important information allowing health care practitioners, policy makers and patients to make better-informed decisions regarding treatment choices for chronic neck pain. Importantly, it will serve to increase the extremely limited research that currently exists for this significant health-care condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Chiropractic + Supervised Rehabilitative Exercise |
| 2 | Experimental | Procedure: Supervised Rehabilitative Exercise |
| 3 | Active comparator | Behavioral: Self-care education |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic mechanical neck pain (defined as current episode > 12 weeks' duration).
- Quebec Task Force classifications 1, 2, 3 and 4. This includes patients with neck pain, stiffness or tenderness, with or without musculoskeletal and neurological signs.
Key exclusion criteria (13 listed)
- Previous cervical spine surgery
- Neck pain referred from local joint lesions of the lower extremities or from visceral diseases
- Progressive neurological deficits due to nerve root or spinal cord compression
- Existing cardiac disease requiring medical treatment
- Blood clotting disorders
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 |
|---|---|---|
| Chiropractic + Supervised Rehabilitative ExerciseChiropractic care will include manual spinal manipulation, with light soft tissue massage as indicated to facilitate the spinal manipulative therapy. The spinal levels treated will be determined by the individual chiropractors by static and/or motion palpation. Patients will attend 20, 1 hour sessions of rehabilitative exercises for the neck and upper body. Each session will begin with a 10-minute aerobic warm-up of the upper body and five minutes of light stretching to prepare for the strengthening exercises. | Procedure or surgery | 1 |
| Supervised Rehabilitative ExercisePatients will attend 20, 1 hour sessions of rehabilitative exercises for the neck and upper body. Each session will begin with a 10-minute aerobic warm-up of the upper body and five minutes of light stretching to prepare for the strengthening exercises. | Procedure or surgery | 2 |
| Self-care educationSelf-care education will be provided by the therapist trained in the study protocol. Two, one-hour sessions will be given regarding self-care measures and ergonomics relative to work and activities of daily living. These will include postural instructions and practical demonstrations of proper body mechanics performed with patient participation. | Behavioural | 3 |
Primary outcome
Patient rated pain(0-10 scale,11 box)
Time frame: short term = 12 weeks; long term = 52 weeks
14 secondary outcomes
Neck Disability Index (NDI)at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
General health status at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
Improvement (Global Change)at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
Disability Days at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
Bothersomeness of Symptoms at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
Frequency of Symptoms at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
Patient Satisfaction at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
Depression at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
Medication use at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
Fear-Avoidance Beliefs at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
Cervical range of motion at baseline, weeks 4,12
Time frame: short term = 12 weeks
Cervical Strength and Endurance at baseline, weeks 4,12
Time frame: short term = 12 weeks
Health Care Costs and Utilization at weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
In-depth Interview at week 12
Time frame: 12 weeks
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 20 Nov 2007.
- Derived from this study: PubMed 22024905Evans R, Bronfort G, Schulz C, Maiers M, Bracha Y, Svendsen K, Grimm R, Garvey T, Transfeldt E. Supervised exercise with and without spinal manipulation performs similarly and better than home exercise for chronic neck pain: a randomized controlled trial. Spine (Phila Pa 1976). 2012 May 15;37(11):903-14. doi: 10.1097/BRS.0b013e31823b3bdf.
- Related InfoLink provided by the sponsor.
Related trials for Neck Pain
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Not yet recruiting
Effects of Mobilization With and Without Suboccipital Muscle Release on Pain, Range of Motion, and Disability in Mechanical Neck Pain
Mechanical Neck Pain
Not yet recruiting
Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
Non Specific Neck Pain
Not yet recruitingObservational study
Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
Myofascial Pain Syndrome - Neck
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.
Gert Bronfort, DC, PhD principal investigator
Northwestern Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chiropractic + Supervised Rehabilitative Exercise, Supervised Rehabilitative Exercise and Self-care education in people with Neck Pain, run by Northwestern Health Sciences 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 2 inclusion and 13 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 20 Nov 2007. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Patient rated pain(0-10 scale,11 box) (time frame: short term = 12 weeks; long term = 52 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 NCT00269360, 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 20 Nov 2007; AzTrials last refreshed its copy on 31 Oct 2026.