Neck PainPhase 2NCT00269308
Chiropractic and Exercise for Seniors With Neck Pain
A Phase 2 study testing Chiropractic Manual treatment + home exercise ( procedure+behavior), Supervised rehabilitative exercise + home exercise and Home exercise in people with Neck Pain, run by Northwestern Health Sciences University at 1 site in United States.
Trial summary
The purpose of this randomized clinical trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic neck pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Neck Pain
- What is being tested?
- Chiropractic Manual treatment + home exercise ( procedure+behavior), Supervised rehabilitative exercise + home exercise and Home exercise
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Apr 2008
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Chronic neck pain (Defined as current episode more than 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.
- 65 years of age and older
- Independent ambulation
- Community dwelling (residency outside nursing home)
- Score of 20 or more on Folstein Mini-Mental State Examination
- Stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in previous month)
Who cannot join
- Referred neck pain from local joint lesions of the upper extremities or from visceral diseases
- Significant infectious disease
- Ongoing treatment for neck pain by other health care providers
- Mean neck pain score of less than 20 percentage points
- Contraindications to exercise Determined by history or by referral to supplementary diagnostic tests (i.e., uncontrolled arrhythmias, third degree heart block, recent ECG changes, unstable angina, acute myocardial infarction, acute congestive heart failure, cardiomyopathy, valvular heart disease, poorly controlled blood pressure, uncontrolled metabolic disease)
- Contraindications to spinal manipulation (i.e. Progressive neurological deficits, blood clotting disorders, severe osteoporosis, infectious and non-infectious inflammatory or destructive tissue changes of the spine)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University
Bloomington, Minnesota, 55431
About this study
Official title: Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise, Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individual 65 and Over With Chronic Mechanical Neck Pain
The purpose of this randomized clinical trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic neck pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.
Read the detailed description
Neck pain (NP) is a considerable health problem, affecting both young and elderly individuals. Of particular concern is the negative impact NP may have on the functional ability of the geriatric population, already challenged by decreased mobility and balance associated with ageing. Chiropractic manual treatment and rehabilitative exercise have demonstrated potential for the treatment of NP in younger individuals, but have yet to be rigorously tested in the elderly.
The broad, long-term objective of this research is to identify effective therapies for patients, 65 years and older, who suffer with chronic neck pain and to enhance their functional capacity.
Primary Aims
- To determine the relative clinical effectiveness of 1) chiropractic manual treatment and home exercise, 2) supervised rehabilitative exercise and home exercise, and 3) home exercise alone in both the short-term (after 12 weeks) and long-term (after 52 weeks), using patient-rated neck pain as the main outcome measure.
Secondary Aims
- To estimate the short- and long-term relative effectiveness of the three interventions using:
- Patient-rated outcomes: neck related disability, general health status, patient satisfaction, improvement, and medication use measured by self-report questionnaires;
- Objective functional performance outcomes: neck motion, strength and endurance, and functional ability measured by examiners masked to treatment group assignment;
- Cost measures: direct and indirect costs, and cost utility of treatment measured by questionnaires, phone interviews, and medical records.
- To describe patients' perceptions of treatment and the issues they consider when determining their satisfaction with care.
This project is a collective effort by a multidisciplinary team, with an established record of collaborative research in the area of neck and back pain. The results of this study will provide valuable information for elderly neck pain sufferers and the clinicians who treat them.
- Conditions
- Neck Pain
- Being tested
- Chiropractic Manual treatment + home exercise ( procedure+behavior), Supervised rehabilitative exercise + home exercise, Home exercise
- Keywords
- Randomized, Clinical Trial, Neck Pain, Chiropractic, Manual Therapies, Exercise
- 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 Manual treatment + home exercise ( procedure+behavior)Procedure or surgery
The number of treatments will be determined by the individual chiropractor. Chiropractic manual treatment will be limited to gentle spinal manipulation and mobilization with light soft tissue massage as indicated to facilitate the manual therapy.
Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active
Supervised rehabilitative exercise + home exerciseProcedure or surgery
The rehabilitative exercise program will consist of 20, 1 hour small-group sessions. It is a modification of exercise protocols used in previous studies by the investigators and others and incorporates recommendations of leading rehabilitative exercise specialists. The program will include exercises that reduce joint stiffness and relax elastic structures resulting in lower joint loads during movements.
Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active
Home exerciseBehavioural
Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Chiropractic Manual Treatment + Home Exercise Receives: Procedure: Chiropractic Manual treatment + home exercise ( procedure+behavior) |
| 2 | Experimental | Supervised Rehabilitative Exercise + Home Exercise Receives: Procedure: Supervised rehabilitative exercise + home exercise |
| 3 | Active comparator | Home Exercise Receives: Behavioral: Home exercise |
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 (6)
General Health
Measured: short term = 12 weeks; long term = 52 weeks
Disability
Measured: short term = 12 weeks; long term = 52 weeks
Improvement
Measured: short term = 12 weeks; long term = 52 weeks
Satisfaction
Measured: short term = 12 weeks; long term = 52 weeks
Medication use
Measured: short term = 12 weeks; long term = 52 weeks
Biomechanical tests: Cervical spine motion, Strength and Endurance, Functional Ability, Observed Pain Behavior
Measured: short term = 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 startOct 2003
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 241 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
- Responsible party
- Sponsor
- Investigators
- Gert Bronfort, DC, PhD, Principal investigator, Northwestern Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269308
- Sponsor's protocol ID
- R18HP01425
- Status last verified
- Aug 2011
- First submitted
- 21 Dec 2005
- Last updated
- 23 Aug 2011
- Results posted
- No
Publications
Leininger B, McDonough C, Evans R, Tosteson T, Tosteson AN, Bronfort G. Cost-effectiveness of spinal manipulative therapy, supervised exercise, and home exercise for older adults with chronic neck pain. Spine J. 2016 Nov;16(11):1292-1304. doi: 10.1016/j.spinee.2016.06.014. Epub 2016 Jun 23.
PubMed 27345747Maiers M, Bronfort G, Evans R, Hartvigsen J, Svendsen K, Bracha Y, Schulz C, Schulz K, Grimm R. Spinal manipulative therapy and exercise for seniors with chronic neck pain. Spine J. 2014 Sep 1;14(9):1879-89. doi: 10.1016/j.spinee.2013.10.035. Epub 2013 Nov 10.
PubMed 24225010Maiers MJ, Hartvigsen J, Schulz C, Schulz K, Evans RL, Bronfort G. Chiropractic and exercise for seniors with low back pain or neck pain: the design of two randomized clinical trials. BMC Musculoskelet Disord. 2007 Sep 18;8:94. doi: 10.1186/1471-2474-8-94.
PubMed 17877825
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise, Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individual 65 and Over With Chronic Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT00269308
- Acronym / sponsor ID
- R18HP01425
- Conditions
- Neck Pain
- Keywords
- Randomized, Clinical Trial, Neck Pain, Chiropractic, Manual Therapies, Exercise
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 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
- Oct 2003
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (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 randomized clinical trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic neck pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.
Detailed description
Neck pain (NP) is a considerable health problem, affecting both young and elderly individuals. Of particular concern is the negative impact NP may have on the functional ability of the geriatric population, already challenged by decreased mobility and balance associated with ageing. Chiropractic manual treatment and rehabilitative exercise have demonstrated potential for the treatment of NP in younger individuals, but have yet to be rigorously tested in the elderly.
The broad, long-term objective of this research is to identify effective therapies for patients, 65 years and older, who suffer with chronic neck pain and to enhance their functional capacity.
Primary Aims
- To determine the relative clinical effectiveness of 1) chiropractic manual treatment and home exercise, 2) supervised rehabilitative exercise and home exercise, and 3) home exercise alone in both the short-term (after 12 weeks) and long-term (after 52 weeks), using patient-rated neck pain as the main outcome measure.
Secondary Aims
- To estimate the short- and long-term relative effectiveness of the three interventions using:
- Patient-rated outcomes: neck related disability, general health status, patient satisfaction, improvement, and medication use measured by self-report questionnaires;
- Objective functional performance outcomes: neck motion, strength and endurance, and functional ability measured by examiners masked to treatment group assignment;
- Cost measures: direct and indirect costs, and cost utility of treatment measured by questionnaires, phone interviews, and medical records.
- To describe patients' perceptions of treatment and the issues they consider when determining their satisfaction with care.
This project is a collective effort by a multidisciplinary team, with an established record of collaborative research in the area of neck and back pain. The results of this study will provide valuable information for elderly neck pain sufferers and the clinicians who treat them.
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 Manual treatment + home exercise ( procedure+behavior)Chiropractic Manual Treatment + Home Exercise |
| 2 | Experimental | Procedure: Supervised rehabilitative exercise + home exerciseSupervised Rehabilitative Exercise + Home Exercise |
| 3 | Active comparator | Behavioral: Home exerciseHome Exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Chronic neck pain (Defined as current episode more than 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.
- 65 years of age and older
- Independent ambulation
- Community dwelling (residency outside nursing home)
Key exclusion criteria (6 listed)
- Referred neck pain from local joint lesions of the upper extremities or from visceral diseases
- Significant infectious disease
- Ongoing treatment for neck pain by other health care providers
- Mean neck pain score of less than 20 percentage points
- Contraindications to exercise Determined by history or by referral to supplementary diagnostic tests (i.e., uncontrolled arrhythmias, third degree heart block, recent ECG changes, unstable angina, acute myocardial infarction, acute congestive heart failure, cardiomyopathy, valvular heart disease, poorly controlled blood pressure, uncontrolled metabolic disease)
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 Manual treatment + home exercise ( procedure+behavior)The number of treatments will be determined by the individual chiropractor. Chiropractic manual treatment will be limited to gentle spinal manipulation and mobilization with light soft tissue massage as indicated to facilitate the manual therapy. Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active | Procedure or surgery | 1 |
| Supervised rehabilitative exercise + home exerciseThe rehabilitative exercise program will consist of 20, 1 hour small-group sessions. It is a modification of exercise protocols used in previous studies by the investigators and others and incorporates recommendations of leading rehabilitative exercise specialists. The program will include exercises that reduce joint stiffness and relax elastic structures resulting in lower joint loads during movements. Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active | Procedure or surgery | 2 |
| Home exercisePatients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active. | Behavioural | 3 |
Primary outcome
Patient-rated pain (0-10 scale, 11 box)
Time frame: short term = 12 weeks; long term = 52 weeks
6 secondary outcomes
General Health
Time frame: short term = 12 weeks; long term = 52 weeks
Disability
Time frame: short term = 12 weeks; long term = 52 weeks
Improvement
Time frame: short term = 12 weeks; long term = 52 weeks
Satisfaction
Time frame: short term = 12 weeks; long term = 52 weeks
Medication use
Time frame: short term = 12 weeks; long term = 52 weeks
Biomechanical tests: Cervical spine motion, Strength and Endurance, Functional Ability, Observed Pain Behavior
Time frame: short term = 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 23 Aug 2011.
- Derived from this study: PubMed 27345747Leininger B, McDonough C, Evans R, Tosteson T, Tosteson AN, Bronfort G. Cost-effectiveness of spinal manipulative therapy, supervised exercise, and home exercise for older adults with chronic neck pain. Spine J. 2016 Nov;16(11):1292-1304. doi: 10.1016/j.spinee.2016.06.014. Epub 2016 Jun 23.
- Derived from this study: PubMed 24225010Maiers M, Bronfort G, Evans R, Hartvigsen J, Svendsen K, Bracha Y, Schulz C, Schulz K, Grimm R. Spinal manipulative therapy and exercise for seniors with chronic neck pain. Spine J. 2014 Sep 1;14(9):1879-89. doi: 10.1016/j.spinee.2013.10.035. Epub 2013 Nov 10.
- Derived from this study: PubMed 17877825Maiers MJ, Hartvigsen J, Schulz C, Schulz K, Evans RL, Bronfort G. Chiropractic and exercise for seniors with low back pain or neck pain: the design of two randomized clinical trials. BMC Musculoskelet Disord. 2007 Sep 18;8:94. doi: 10.1186/1471-2474-8-94.
- Related InfoLink provided by the sponsor.
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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.
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 Manual treatment + home exercise ( procedure+behavior), Supervised rehabilitative exercise + home exercise and Home exercise 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 7 inclusion and 6 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 23 Aug 2011. 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 NCT00269308, which also lists 3 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 23 Aug 2011.