Chronic Neck PainNCT01122836
Dosing Study of Massage for Neck Pain
A study testing Massage in people with Chronic Neck Pain, run by Kaiser Permanente at 1 site in United States.
Trial summary
This study is designed to determine the most effective dose of massage for persons with chronic neck pain. This information is necessary before more definitive studies can be conducted. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Mar 2014
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptoms consistent with non-specific, uncomplicated neck pain of at least moderate level of pain
- Lives or works within Greater Seattle WA geographic area
Who cannot join
- Cervical Radiculopathy
- History of cancer (other than nonmelanoma skin cancer)
- Severe disk problems
- Unstable medical conditions
- Previous neck surgery
- Physically unable to get on and off of a massage table
Show all 11Show fewer
- Has had massage within the last year
- Currently in litigation for neck pain
- Seeking other treatment for neck pain
- Potential contraindications for massage
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Group Health Research Institute
Seattle, Washington, 98101
About this study
This study is designed to determine the most effective dose of massage for persons with chronic neck pain. This information is necessary before more definitive studies can be conducted.
Read the detailed description
This study's long-term objective is to identify effective treatments for with neck pain. Many Americans have found conventional medical treatments ineffective for this common and costly problem and are increasingly trying complementary and alternative treatments, including therapeutic massage. Despite the growing popularity of massage, its effectiveness for treating neck pain remains unclear, largely because of the poor quality of research in this area. A major deficiency of previous studies has been their use of low "doses" of massage that massage therapists consider inadequate. Unfortunately, the numbers of minutes per massage session, sessions per weeks, or weeks of treatment necessary for massage to have beneficial or optimal effects are not known. This study is designed to address these gaps in our knowledge by determining, for persons with chronic neck pain: 1) the optimal combination of number of treatments per week and length of individual treatment session, and 2) the optimal number of weeks of treatment. In this project, 228 persons with chronic non-specific neck pain will be randomized to a wait list control group or 4 weeks of treatment with one of 5 different dosing combinations (2 or 3 30-minute treatments per week or 1, 2, or 3 60-minute treatments per week). At the end of this 4 week primary treatment period, participants initially receiving each of the 5 dosing combinations will be randomized to a secondary treatment period of either no additional treatment or 6 weekly 60-minute massages. The primary outcomes, neck-related dysfunction and pain, will be assessed by blinded telephone interviewers 4, 10, and 26 weeks post-randomization. To better characterize the trajectory of the persistence of treatment effects, these interview data will be supplemented with outcomes data collected by mailed questionnaire at 8, 14, 18 and 39 weeks. Comparisons of outcomes for the 6 groups during the primary treatment period will identify the optimal weekly dose, while comparisons of outcomes during the secondary treatment period will determine if 10 weeks of treatment is superior to 4 weeks. The results of this study will: 1) guide the development of a massage treatment protocol to be used in a full-scale trial evaluating the effectiveness of therapeutic massage for chronic neck pain, 2) serve as a model for future dosing studies of massage and bodywork, and 3) help interpret the adequacy of the dosing of massage used in past studies of massage for neck pain
- Conditions
- Chronic Neck Pain
- Being tested
- Massage
- Keywords
- Massage, Chronic Neck Pain, Dosing Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
Therapeutic Massage
| Study group | Role | What they receive |
|---|---|---|
| Massage Dose 1 | Experimental | This arm receives weekly 60-minute massage for 4 weeks after a 4-week period of no treatment. Receives: Other: Massage |
| Massage - Dose 2 | Experimental | This arm receives weekly 60-minute massage for 4 weeks. Receives: Other: Massage |
| Massage - Dose 3 | Experimental | This arm receives 2 weekly 30-minute massage for 4 weeks. Receives: Other: Massage |
| Massage - Dose 4 | Experimental | This arm receives 2 weekly 60-minute massages for 4 weeks. Receives: Other: Massage |
| Massage - Dose 5 | Experimental | This arm receives 3 weekly 30-minute massages for 4 weeks. Receives: Other: Massage |
| Massage - Dose 6 | Experimental | This arm receives 3 weekly 60-minute massages for 4 weeks. Receives: Other: Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in neck related dysfunction
Evidence of clinically important improvement according to the Neck Pain Disability Index
Measured: 4 weeks
Improvement in pain levels
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2011
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Karen J Sherman, MPH, PhD, Principal investigator, Group Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122836
- Sponsor's protocol ID
- 5R01AT004411-02
- Status last verified
- Oct 2017
- First submitted
- 11 May 2010
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cook AJ, Wellman RD, Cherkin DC, Kahn JR, Sherman KJ. Randomized clinical trial assessing whether additional massage treatments for chronic neck pain improve 12- and 26-week outcomes. Spine J. 2015 Oct 1;15(10):2206-15. doi: 10.1016/j.spinee.2015.06.049. Epub 2015 Jun 19.
PubMed 26096474Sherman KJ, Cook AJ, Kahn JR, Hawkes RJ, Wellman RD, Cherkin DC. Dosing study of massage for chronic neck pain: protocol for the dose response evaluation and analysis of massage [DREAM] trial. BMC Complement Altern Med. 2012 Sep 18;12:158. doi: 10.1186/1472-6882-12-158.
PubMed 22985134
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosing Study of Massage for Neck Pain
- ClinicalTrials.gov ID
- NCT01122836
- Acronym / sponsor ID
- 5R01AT004411-02
- Conditions
- Chronic Neck Pain
- Keywords
- Massage, Chronic Neck Pain, Dosing Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jul 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 May 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.
This study is designed to determine the most effective dose of massage for persons with chronic neck pain. This information is necessary before more definitive studies can be conducted.
Detailed description
This study's long-term objective is to identify effective treatments for with neck pain. Many Americans have found conventional medical treatments ineffective for this common and costly problem and are increasingly trying complementary and alternative treatments, including therapeutic massage. Despite the growing popularity of massage, its effectiveness for treating neck pain remains unclear, largely because of the poor quality of research in this area. A major deficiency of previous studies has been their use of low "doses" of massage that massage therapists consider inadequate. Unfortunately, the numbers of minutes per massage session, sessions per weeks, or weeks of treatment necessary for massage to have beneficial or optimal effects are not known. This study is designed to address these gaps in our knowledge by determining, for persons with chronic neck pain: 1) the optimal combination of number of treatments per week and length of individual treatment session, and 2) the optimal number of weeks of treatment. In this project, 228 persons with chronic non-specific neck pain will be randomized to a wait list control group or 4 weeks of treatment with one of 5 different dosing combinations (2 or 3 30-minute treatments per week or 1, 2, or 3 60-minute treatments per week). At the end of this 4 week primary treatment period, participants initially receiving each of the 5 dosing combinations will be randomized to a secondary treatment period of either no additional treatment or 6 weekly 60-minute massages. The primary outcomes, neck-related dysfunction and pain, will be assessed by blinded telephone interviewers 4, 10, and 26 weeks post-randomization. To better characterize the trajectory of the persistence of treatment effects, these interview data will be supplemented with outcomes data collected by mailed questionnaire at 8, 14, 18 and 39 weeks. Comparisons of outcomes for the 6 groups during the primary treatment period will identify the optimal weekly dose, while comparisons of outcomes during the secondary treatment period will determine if 10 weeks of treatment is superior to 4 weeks. The results of this study will: 1) guide the development of a massage treatment protocol to be used in a full-scale trial evaluating the effectiveness of therapeutic massage for chronic neck pain, 2) serve as a model for future dosing studies of massage and bodywork, and 3) help interpret the adequacy of the dosing of massage used in past studies of massage for neck pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Massage Dose 1 | Experimental | Other: MassageThis arm receives weekly 60-minute massage for 4 weeks after a 4-week period of no treatment. |
| Massage - Dose 2 | Experimental | Other: MassageThis arm receives weekly 60-minute massage for 4 weeks. |
| Massage - Dose 3 | Experimental | Other: MassageThis arm receives 2 weekly 30-minute massage for 4 weeks. |
| Massage - Dose 4 | Experimental | Other: MassageThis arm receives 2 weekly 60-minute massages for 4 weeks. |
| Massage - Dose 5 | Experimental | Other: MassageThis arm receives 3 weekly 30-minute massages for 4 weeks. |
| Massage - Dose 6 | Experimental | Other: MassageThis arm receives 3 weekly 60-minute massages for 4 weeks. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Symptoms consistent with non-specific, uncomplicated neck pain of at least moderate level of pain
- Lives or works within Greater Seattle WA geographic area
Key exclusion criteria (11 listed)
- Cervical Radiculopathy
- History of cancer (other than nonmelanoma skin cancer)
- Severe disk problems
- Unstable medical conditions
- Previous neck surgery
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 |
|---|---|---|
| MassageTherapeutic Massage | Other | Massage - Dose 2, Massage - Dose 3, Massage - Dose 4, Massage - Dose 5, Massage - Dose 6, Massage Dose 1 |
Primary outcome
Improvement in neck related dysfunction
Time frame: 4 weeks
Evidence of clinically important improvement according to the Neck Pain Disability Index
Improvement in pain levels
Time frame: 4 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 13 Oct 2017.
- Derived from this study: PubMed 26096474Cook AJ, Wellman RD, Cherkin DC, Kahn JR, Sherman KJ. Randomized clinical trial assessing whether additional massage treatments for chronic neck pain improve 12- and 26-week outcomes. Spine J. 2015 Oct 1;15(10):2206-15. doi: 10.1016/j.spinee.2015.06.049. Epub 2015 Jun 19.
- Derived from this study: PubMed 22985134Sherman KJ, Cook AJ, Kahn JR, Hawkes RJ, Wellman RD, Cherkin DC. Dosing study of massage for chronic neck pain: protocol for the dose response evaluation and analysis of massage [DREAM] trial. BMC Complement Altern Med. 2012 Sep 18;12:158. doi: 10.1186/1472-6882-12-158.
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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.
Karen J Sherman, MPH, PhD principal investigator
Group Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage in people with Chronic Neck Pain, run by Kaiser Permanente 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 11 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 13 Oct 2017. 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?
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?
Improvement in neck related dysfunction (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT01122836, which also lists 2 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 13 Oct 2017.