Neck PainPhase 2NCT01092715
Cervical Mobilization vs. Standard Physical Therapy for Chronic Neck Pain
A Phase 2 study testing Spinal mobilization, Massage and Neck exercises in people with Neck Pain, run by Mayo Clinic at 1 site in United States.
Trial summary
Neck pain is a common problem in our society, accounting for 20% of all chiropractic visits. Physical therapy interventions for chronic neck pain have been chosen based on the patient's symptoms and examination findings. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Spinal mobilization, Massage and Neck exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Jun 2004
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neck pain of at least 12 weeks duration
Who cannot join
- Signs and/or symptoms of cervical radiculopathy or myelopathy
- Symptomatic shoulder pathology
- History of cervical spine surgery
- History of motor vehicle collision within the past three years
- Recent neck or shoulder trauma
- Fibromyalgia or generalized pain syndrome
- History of cancer affecting the head or neck
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Dept of Physical Medicine & Rehabilitation
Rochester, Minnesota, 55905
About this study
Official title: A Comparison of Cervical Spine Mobilization and "Standard" Physical Therapy Intervention in the Treatment of Chronic Neck Pain, A Pilot Study
Neck pain is a common problem in our society, accounting for 20% of all chiropractic visits. Physical therapy interventions for chronic neck pain have been chosen based on the patient's symptoms and examination findings. These interventions include superficial and deep heat, massage, traction, manual therapy, and exercise programs. There is little controlled research addressing the efficacy of these therapies. Although many of these interventions provide some patients with pain relief and increased function, studies often utilize multiple interventions on the same subject such as heat, ultrasound, cervical traction, range of motion exercises, making interpretation of the results difficult. Much of the literature to date has focused on studies of subjects suffering from acute neck pain. Many of these studies suggest that subjects report decreased pain, decreased disability and increased cervical spine active range of motion. There are no controlled studies comparing the effects of spinal mobilization and standard physical therapy on subjects with chronic neck pain. The object of this study is two fold: 1) to determine the score variability of two neck disability questionnaires )both baseline and change scores) to be used in sample size calculations, and 2) to establish the ability to recruit, treat and follow sufficient numbers of subjects needed for a full clinical trial. The ability to predict outcomes of neck pain treatment will lead to more appropriate therapies and an avoidance of unnecessary treatments.
Read the detailed description
Background and Purpose: Chronic neck pain is a common problem. Studies of physical therapy for neck pain often utilize multiple interventions on the same subject making interpretation of the results difficult. The objectives of this study were two fold, 1) to establish the ability to recruit and treat subjects needed for a clinical trial of mobilization vs. massage for neck pain and 2) to estimate the variability of the Neck Disability Index (NDI) in a defined population of patients with neck pain and determine sample size for a trial. Subjects and
Methods: Subjects were randomized to either sedative massage (SM) to the neck and upper back or joint mobilization to the cervical spine (JM). All subjects also received moist heat and a home exercise program. Outcomes tracked for establishing trial feasibility included the number of referrals, number of referrals meeting inclusion criteria, number of subjects declining to participate and reasons for their refusal, acceptance rate of randomization, number of dropouts, and reasons for dropout. Descriptive statistics and baseline data were analyzed with means and standard deviations when appropriate. Groups were compared in regard to demographic and clinical characteristics only. The Neck Disability Index scores were calculated for pre-treatment, post-treatment, and change scores within each group.
- Conditions
- Neck Pain
- Being tested
- Spinal mobilization, Massage, Neck exercises
- Keywords
- Neck pain, Spinal manipulation, Massage
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal mobilizationProcedure or surgery
Non thrust mobilization to the cervical spine
MassageProcedure or surgery
Sedative massage to cervical paraspinal muscles
Neck exercisesProcedure or surgery
Range of motion exercises to include foraminal opening
| Study group | Role | What they receive |
|---|---|---|
| Mobilization | Experimental | Spinal mobilization and exercises Receives: Procedure: Spinal mobilization; Procedure: Neck exercises |
| Massage | Active comparator | Neck massage and exercises Receives: Procedure: Massage; Procedure: Neck exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Neck Disability Index score (patient generated score from questionnaire)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startJun 2003
- Primary completionJun 2004
- Study completionJun 2004
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Timothy J Madson, PT, Principal investigator, Mayo ClinicTimothy J Madson, PT, Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092715
- Sponsor's protocol ID
- 1423-02
- Status last verified
- Mar 2010
- First submitted
- 23 Mar 2010
- Last updated
- 25 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Cervical Spine Mobilization and "Standard" Physical Therapy Intervention in the Treatment of Chronic Neck Pain, A Pilot Study
- ClinicalTrials.gov ID
- NCT01092715
- Acronym / sponsor ID
- 1423-02
- Conditions
- Neck Pain
- Keywords
- Neck pain, Spinal manipulation, Massage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 25 Mar 2010 (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.
Neck pain is a common problem in our society, accounting for 20% of all chiropractic visits. Physical therapy interventions for chronic neck pain have been chosen based on the patient's symptoms and examination findings. These interventions include superficial and deep heat, massage, traction, manual therapy, and exercise programs. There is little controlled research addressing the efficacy of these therapies. Although many of these interventions provide some patients with pain relief and increased function, studies often utilize multiple interventions on the same subject such as heat, ultrasound, cervical traction, range of motion exercises, making interpretation of the results difficult. Much of the literature to date has focused on studies of subjects suffering from acute neck pain. Many of these studies suggest that subjects report decreased pain, decreased disability and increased cervical spine active range of motion. There are no controlled studies comparing the effects of spinal mobilization and standard physical therapy on subjects with chronic neck pain. The object of this study is two fold: 1) to determine the score variability of two neck disability questionnaires )both baseline and change scores) to be used in sample size calculations, and 2) to establish the ability to recruit, treat and follow sufficient numbers of subjects needed for a full clinical trial. The ability to predict outcomes of neck pain treatment will lead to more appropriate therapies and an avoidance of unnecessary treatments.
Detailed description
Background and Purpose: Chronic neck pain is a common problem. Studies of physical therapy for neck pain often utilize multiple interventions on the same subject making interpretation of the results difficult. The objectives of this study were two fold, 1) to establish the ability to recruit and treat subjects needed for a clinical trial of mobilization vs. massage for neck pain and 2) to estimate the variability of the Neck Disability Index (NDI) in a defined population of patients with neck pain and determine sample size for a trial. Subjects and
Methods: Subjects were randomized to either sedative massage (SM) to the neck and upper back or joint mobilization to the cervical spine (JM). All subjects also received moist heat and a home exercise program. Outcomes tracked for establishing trial feasibility included the number of referrals, number of referrals meeting inclusion criteria, number of subjects declining to participate and reasons for their refusal, acceptance rate of randomization, number of dropouts, and reasons for dropout. Descriptive statistics and baseline data were analyzed with means and standard deviations when appropriate. Groups were compared in regard to demographic and clinical characteristics only. The Neck Disability Index scores were calculated for pre-treatment, post-treatment, and change scores within each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobilization | Experimental | Procedure: Spinal mobilization, Procedure: Neck exercisesSpinal mobilization and exercises |
| Massage | Active comparator | Procedure: Massage, Procedure: Neck exercisesNeck massage and exercises |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Neck pain of at least 12 weeks duration
Key exclusion criteria (7 listed)
- Signs and/or symptoms of cervical radiculopathy or myelopathy
- Symptomatic shoulder pathology
- History of cervical spine surgery
- History of motor vehicle collision within the past three years
- Recent neck or shoulder trauma
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 |
|---|---|---|
| Spinal mobilizationNon thrust mobilization to the cervical spine | Procedure or surgery | Mobilization |
| MassageSedative massage to cervical paraspinal muscles | Procedure or surgery | Massage |
| Neck exercisesRange of motion exercises to include foraminal opening | Procedure or surgery | Massage, Mobilization |
Primary outcome
Neck Disability Index
Time frame: 6 weeks
Neck Disability Index score (patient generated score from questionnaire)
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 25 Mar 2010.
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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.
Timothy J Madson, PT principal investigator
Mayo Clinic
Timothy J Madson, PT study director
Mayo Clinic
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 Spinal mobilization, Massage and Neck exercises in people with Neck Pain, run by Mayo Clinic 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 1 inclusion and 7 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 25 Mar 2010. 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?
Neck Disability Index (time frame: 6 weeks). 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 25 Mar 2010.