Chronic Low Back Pain (Non-specific, Uncomplicated)Phase 2/3NCT00371384
Effect of Massage on Chronic Low Back Pain
A Phase 2/3 study testing massage in people with Chronic Low Back Pain (Non-specific, Uncomplicated), run by Kaiser Permanente at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of two types of massage therapy for treating chronic low back pain. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Chronic Low Back Pain (Non-specific, Uncomplicated)
- What is being tested?
- massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Sep 2009
- Phase
- Phase 2/3
- 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
- 20 through 64 years of age
- members of Group Health Cooperative health plan
- low back pain lasting at least 3 months
Who cannot join
- non-mechanical causes of back pain (e.g., sciatica, systemic/visceral disease, pregnancy, spondylolisthesis, spinal stenosis, cancer, recent vertebral fracture)
- inappropriate candidate for massage (active open skin lesions, conditions exacerbated by increased circulation, recent strokes or heart attacks, compromised immune system, systemic edema, hypersensitivity to touch or loss of sensation, recent surgery, active contagious infection)
- characteristics complicating the interpretation of findings (e.g., involved with litigation or compensation claim, severe or progressive neurological deficit, back surgery within last 3 years, receiving other back treatment)
- unable to speak or read English
- had massage for any reason in prior 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Group Health Center for Health Studies
Seattle, Washington, 98101
About this study
This study will evaluate the effectiveness of two types of massage therapy for treating chronic low back pain.
Read the detailed description
Americans are increasingly seeking care from massage therapists for relief of chronic back pain. However, while initial studies suggest that massage is beneficial for back pain, we have no information about which of the many types of massage is most helpful. We will be conducting a study that compares two distinct therapeutic massage protocols with each other and with usual care for treating chronic back pain. This study is designed to determine which of these massage protocols will be most effective in reducing pain and increasing functionality in people with low back pain. 399 Group Health members with non-specific low back pain lasting at least 3 months will be randomized to one of the two massage groups or to a control group that receives no treatment beyond their usual care. Massage therapists will provide each participant with 10 treatments over 10 weeks. The primary outcomes, function and bothersomeness of low back pain, will be assessed before treatment begins and 10, 26 and 52 weeks after randomization by interviewers who do not know which treatment the participant received. The results of this study will clarify the value of two different types of massage for treating one of the most common, challenging, and expensive health problems plaguing developed countries. The findings will help physicians make informed and confident referrals, consumers and insurers make safe and cost-effective choices, and massage schools make responsible curriculum decisions.
- Being tested
- massage
- Keywords
- massage, back pain, effectiveness
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageProcedure or surgery
UP to 10 massages over 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | structural massage Receives: Procedure: massage |
| 1 | Experimental | relaxation massage Receives: Procedure: massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysfunction at 10 weeks
Measured: 10 weeks
Symptom bothersomeness at 10 weeks
Measured: 10 weeks
Secondary outcomes (13)
Dysfunction at 26 and 52 weeks
Measured: 26 and 52 weeks
Symptom bothersomeness at 26 and 52 weeks
Measured: 26 adn 52 weeks
Anxiety at 10, 26 and 52 weeks
Measured: 10 16 and 52 weeks
Depression at 10, 26 and 52 weeks
Measured: 10 26 and 52 weeks
Perceived stress at 10, 26 and 52 weeks
Measured: 10 26 and 52 weeks
Fear avoidance at 10, 26 and 52 weeks
Measured: 10 26 and 52 weeks
Satisfaction with back care at 10 and 26 weeks
Measured: 10 and 26 weeks
General health status (SF-36) at 10, 26 and 52 weeks
Measured: 10, 26 and 52 weeks
Disability days at 10, 26 and 52 weeks
Measured: 10 26 52 weeks
Medication use at 10, 26 and 52 weeks
Measured: 10 26 52 weeks
Adverse experiences at 10 weeks
Measured: 10 weeks
Perceptions of massage treatments at 10, 26 and 52 weeks
Measured: 10 26 52 weeks
Use and cost of health care services for back pain at 10, 26 and 52 weeks
Measured: 10 26 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startAug 2006
- Primary completionMar 2009
- Study completionSep 2009
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 Low Back Pain (Non-specific, Uncomplicated)Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 399 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
- Dan C Cherkin, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371384
- Sponsor's protocol ID
- R01AT001927
- Other IDs
- R01AT001927
- Status last verified
- Oct 2017
- First submitted
- 31 Aug 2006
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cherkin DC, Sherman KJ, Kahn J, Wellman R, Cook AJ, Johnson E, Erro J, Delaney K, Deyo RA. A comparison of the effects of 2 types of massage and usual care on chronic low back pain: a randomized, controlled trial. Ann Intern Med. 2011 Jul 5;155(1):1-9. doi: 10.7326/0003-4819-155-1-201107050-00002.
PubMed 21727288Cherkin DC, Sherman KJ, Kahn J, Erro JH, Deyo RA, Haneuse SJ, Cook AJ. Effectiveness of focused structural massage and relaxation massage for chronic low back pain: protocol for a randomized controlled trial. Trials. 2009 Oct 20;10:96. doi: 10.1186/1745-6215-10-96.
PubMed 19843340
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
- Effect of Massage on Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00371384
- Acronym / sponsor ID
- R01AT001927
- Keywords
- massage, back pain, effectiveness
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Aug 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 4 Sep 2006 (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 will evaluate the effectiveness of two types of massage therapy for treating chronic low back pain.
Detailed description
Americans are increasingly seeking care from massage therapists for relief of chronic back pain. However, while initial studies suggest that massage is beneficial for back pain, we have no information about which of the many types of massage is most helpful. We will be conducting a study that compares two distinct therapeutic massage protocols with each other and with usual care for treating chronic back pain. This study is designed to determine which of these massage protocols will be most effective in reducing pain and increasing functionality in people with low back pain. 399 Group Health members with non-specific low back pain lasting at least 3 months will be randomized to one of the two massage groups or to a control group that receives no treatment beyond their usual care. Massage therapists will provide each participant with 10 treatments over 10 weeks. The primary outcomes, function and bothersomeness of low back pain, will be assessed before treatment begins and 10, 26 and 52 weeks after randomization by interviewers who do not know which treatment the participant received. The results of this study will clarify the value of two different types of massage for treating one of the most common, challenging, and expensive health problems plaguing developed countries. The findings will help physicians make informed and confident referrals, consumers and insurers make safe and cost-effective choices, and massage schools make responsible curriculum decisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Procedure: massagestructural massage |
| 1 | Experimental | Procedure: massagerelaxation massage |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20 through 64 years of age
- members of Group Health Cooperative health plan
- low back pain lasting at least 3 months
Key exclusion criteria (5 listed)
- non-mechanical causes of back pain (e.g., sciatica, systemic/visceral disease, pregnancy, spondylolisthesis, spinal stenosis, cancer, recent vertebral fracture)
- inappropriate candidate for massage (active open skin lesions, conditions exacerbated by increased circulation, recent strokes or heart attacks, compromised immune system, systemic edema, hypersensitivity to touch or loss of sensation, recent surgery, active contagious infection)
- characteristics complicating the interpretation of findings (e.g., involved with litigation or compensation claim, severe or progressive neurological deficit, back surgery within last 3 years, receiving other back treatment)
- unable to speak or read English
- had massage for any reason in prior 12 months
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 |
|---|---|---|
| massageUP to 10 massages over 10 weeks | Procedure or surgery | 1, 2 |
Primary outcome
Dysfunction at 10 weeks
Time frame: 10 weeks
Symptom bothersomeness at 10 weeks
Time frame: 10 weeks
13 secondary outcomes
Dysfunction at 26 and 52 weeks
Time frame: 26 and 52 weeks
Symptom bothersomeness at 26 and 52 weeks
Time frame: 26 adn 52 weeks
Anxiety at 10, 26 and 52 weeks
Time frame: 10 16 and 52 weeks
Depression at 10, 26 and 52 weeks
Time frame: 10 26 and 52 weeks
Perceived stress at 10, 26 and 52 weeks
Time frame: 10 26 and 52 weeks
Fear avoidance at 10, 26 and 52 weeks
Time frame: 10 26 and 52 weeks
Satisfaction with back care at 10 and 26 weeks
Time frame: 10 and 26 weeks
General health status (SF-36) at 10, 26 and 52 weeks
Time frame: 10, 26 and 52 weeks
Disability days at 10, 26 and 52 weeks
Time frame: 10 26 52 weeks
Medication use at 10, 26 and 52 weeks
Time frame: 10 26 52 weeks
Adverse experiences at 10 weeks
Time frame: 10 weeks
Perceptions of massage treatments at 10, 26 and 52 weeks
Time frame: 10 26 52 weeks
Use and cost of health care services for back pain at 10, 26 and 52 weeks
Time frame: 10 26 52 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 21727288Cherkin DC, Sherman KJ, Kahn J, Wellman R, Cook AJ, Johnson E, Erro J, Delaney K, Deyo RA. A comparison of the effects of 2 types of massage and usual care on chronic low back pain: a randomized, controlled trial. Ann Intern Med. 2011 Jul 5;155(1):1-9. doi: 10.7326/0003-4819-155-1-201107050-00002.
- Derived from this study: PubMed 19843340Cherkin DC, Sherman KJ, Kahn J, Erro JH, Deyo RA, Haneuse SJ, Cook AJ. Effectiveness of focused structural massage and relaxation massage for chronic low back pain: protocol for a randomized controlled trial. Trials. 2009 Oct 20;10:96. doi: 10.1186/1745-6215-10-96.
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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.
Dan C Cherkin, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing massage in people with Chronic Low Back Pain (Non-specific, Uncomplicated), 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 3 inclusion and 5 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Dysfunction at 10 weeks (time frame: 10 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 NCT00371384, 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.