Low Back PainNCT01147120
Chronic Low Back Pain and Primary Health Care
A study testing Progressive Muscle Relaxation (PMR) and Clinical Massage Therapy (CMT) in people with Low Back Pain, run by William G Elder JR at 1 site in United States.
Trial summary
Kentucky ranks 2nd in disability among states, with chronic low back pain (CLBP) as a major disability, especially in the investigators rural areas. Kentucky and U.S. health care providers need alternative and effective treatments. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Progressive Muscle Relaxation (PMR) and Clinical Massage Therapy (CMT)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jul 2013
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a visit with the physician during the 4-week study referral period for that practice
- Be 21 years of age or older on the date of the visit
- According to the physician, currently have CLBP
- Have been a patient in the practice for at least 3 months
- Have a life expectancy of 6 months or more
Who cannot join
- Not have a current or past history of psychosis
- Not be pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Family and Community Medicine; University of Kentucky
Lexington, Kentucky, 40536
About this study
Official title: CAM Referral and Outcomes: Chronic Low Back Pain in Urban and Rural Primary Care
Kentucky ranks 2nd in disability among states, with chronic low back pain (CLBP) as a major disability, especially in the investigators rural areas. Kentucky and U.S. health care providers need alternative and effective treatments. Following NCCAM strategic research recommendations, this study will investigate health services outcomes of complementary and alternative medicine (CAM) therapies in an existing primary care practice-based research network (PBRN). The Patients with CLBP are often willing to try therapeutic options outside the conventional medical spectrum. Massage and relaxation therapies have demonstrated fairly good efficacy in controlled trials but their effectiveness in the "real world" of primary care is only beginning to be evaluated. The long-term goal of the proposed project builds on the foundation of these two established therapies to improve treatment of chronic low back pain (CLBP) in primary care practices. Two alternative (CAM) therapies, progressive muscle relaxation (PMR) and clinical massage therapy (CMT), will be studied. The short-term objectives of the proposed project are to: (1) examine outcomes of CAM for patients with CLBP referred from primary care practices, and (2) better understand physician decision-making to recommend CAM therapy for CLBP. Specific Aim 1 will evaluate improvement in health-related outcomes for patients with CLBP when referred to PMR or CMT from primary care. Specific Aim 2 will explore selected factors in primary care physicians' decisions to recommend CAM therapy to these patients. The proposed study is unique in that it addresses "real life" clinical situations and decision-making in both urban and rural clinical practices within an existing PBRN. Should such CAM referral prove successful for ameliorating CLBP, it would provide relatively low cost, non-addictive treatment options for inclusion in the repertoire of primary care physicians.
Read the detailed description
The proposed study will investigate health related outcomes of two CAM treatments recommended by primary care physicians for CLBP, and explore selected elements in the decision process to recommend or not recommend one of two CAM treatments.
Patients and primary care physicians (PCPs) will participate from metropolitan and nonmetropolitan central Kentucky practices of the Kentucky Ambulatory Network (KAN), Kentucky's statewide primary care practice-based research network (PBRN). Each practice will have a patient participant enrollment period of four weeks. Patients with CLBP who have a visit during the enrollment period in a practice may be eligible to participate in the study, and participating PCPs will be invited to recommend as many eligible patients as they feel comfortable. During patient visits, the PCP may offer a recommendation to the patient to receive PMR or CMT. Patients who agree will be recruited by the KAN/CAM project team staff. Patients who enroll in the CAM recommendation study will receive a 12-week course of PMR or CMT treatments. Outcomes will be measured at three time points: baseline, 12 weeks, and 24 weeks.
- Conditions
- Low Back Pain
- Being tested
- Progressive Muscle Relaxation (PMR), Clinical Massage Therapy (CMT)
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle Relaxation (PMR)Behavioural
Progressive Muscle Relaxation (PMR) will be recorded on PDAs integrated with EMA software and offered to patients who will be instructed in the techniques and PDA use by study coordinators. They will be instructed to practice 25 minutes/day the first two weeks, 35 minutes/day weeks 3 and 4, and 45 minutes/day weeks 5 through 12. These time periods (25/35/45 minute) were selected to allow a more gradual acclimation to PMR.
Clinical Massage Therapy (CMT)Procedure or surgery
PCPs will have the opportunity to refer patients with CLBP to local Licensed Massage Therapists (LMTs) to receive up to 10 clinical massage sessions over a 12-week period. CMT will be provided at no cost to the patients. At their first two sessions, the LMT will evaluate the patient and, with the patient, estimate the number of sessions and determine treatment goals. Based on previous literature, 10 sessions are anticipated over an average 12-week period. However, treatment will vary depending on assessment and progress. At the end of the treatment period, the patients will receive a list of all participating LMTs to facilitate patients' continued or future participation in massage therapy.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Muscle Relaxation | Active comparator | Not described Receives: Behavioral: Progressive Muscle Relaxation (PMR) |
| Clinical Massage Therapy | Active comparator | Not described Receives: Procedure: Clinical Massage Therapy (CMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
Survey completed at Baseline, 12 Weeks, and 24 Weeks
Measured: Baseline, 12 Weeks, and 24 Weeks
Short Form 36 (SF-36)
Health related quality of life survey
Measured: Baseline, 12 Weeks, and 24 Weeks
Faces Pain Scale - Revised (FPS-R)
Survey
Measured: Baseline, 12 Weeks, and 24 Weeks
Secondary outcomes (6)
Pain Medication Questionnaire (PMQ) - subset
Survey
Measured: Baseline, 12 Weeks, and 24 Weeks
Expectations for and Satisfaction with Therapies
Survey
Measured: Baseline and 12 Weeks
Tampa Scale of Kinesiophobia (TSK) - Subset
Survey
Measured: Baseline, 12 Weeks, and 24 Weeks
Patient Perceptions of CAM Therapy
Survey
Measured: Baseline, 12 Weeks, and 24 Weeks
Physician Perceptions of CAM Therapy
Survey
Measured: Baseline
Physician Point-of-Care Card
CLBP visit description and reasons to recommend patients for this therapy study.
Measured: 4 weeks per practice (Identify and screen for possible patients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startSep 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- William G Elder JR
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor-investigator, William G Elder JR, University of Kentucky
- Investigators
- William G Elder, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147120
- Sponsor's protocol ID
- 1R21AT004544-01A2
- Other IDs
- 1R21AT004544-01A2
- Status last verified
- Jun 2014
- First submitted
- 30 Mar 2010
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAM Referral and Outcomes: Chronic Low Back Pain in Urban and Rural Primary Care
- ClinicalTrials.gov ID
- NCT01147120
- Acronym / sponsor ID
- 1R21AT004544-01A2
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- William G Elder JRUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 22 Jun 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.
Kentucky ranks 2nd in disability among states, with chronic low back pain (CLBP) as a major disability, especially in the investigators rural areas. Kentucky and U.S. health care providers need alternative and effective treatments. Following NCCAM strategic research recommendations, this study will investigate health services outcomes of complementary and alternative medicine (CAM) therapies in an existing primary care practice-based research network (PBRN). The Patients with CLBP are often willing to try therapeutic options outside the conventional medical spectrum. Massage and relaxation therapies have demonstrated fairly good efficacy in controlled trials but their effectiveness in the "real world" of primary care is only beginning to be evaluated. The long-term goal of the proposed project builds on the foundation of these two established therapies to improve treatment of chronic low back pain (CLBP) in primary care practices. Two alternative (CAM) therapies, progressive muscle relaxation (PMR) and clinical massage therapy (CMT), will be studied. The short-term objectives of the proposed project are to: (1) examine outcomes of CAM for patients with CLBP referred from primary care practices, and (2) better understand physician decision-making to recommend CAM therapy for CLBP. Specific Aim 1 will evaluate improvement in health-related outcomes for patients with CLBP when referred to PMR or CMT from primary care. Specific Aim 2 will explore selected factors in primary care physicians' decisions to recommend CAM therapy to these patients. The proposed study is unique in that it addresses "real life" clinical situations and decision-making in both urban and rural clinical practices within an existing PBRN. Should such CAM referral prove successful for ameliorating CLBP, it would provide relatively low cost, non-addictive treatment options for inclusion in the repertoire of primary care physicians.
Detailed description
The proposed study will investigate health related outcomes of two CAM treatments recommended by primary care physicians for CLBP, and explore selected elements in the decision process to recommend or not recommend one of two CAM treatments.
Patients and primary care physicians (PCPs) will participate from metropolitan and nonmetropolitan central Kentucky practices of the Kentucky Ambulatory Network (KAN), Kentucky's statewide primary care practice-based research network (PBRN). Each practice will have a patient participant enrollment period of four weeks. Patients with CLBP who have a visit during the enrollment period in a practice may be eligible to participate in the study, and participating PCPs will be invited to recommend as many eligible patients as they feel comfortable. During patient visits, the PCP may offer a recommendation to the patient to receive PMR or CMT. Patients who agree will be recruited by the KAN/CAM project team staff. Patients who enroll in the CAM recommendation study will receive a 12-week course of PMR or CMT treatments. Outcomes will be measured at three time points: baseline, 12 weeks, and 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Muscle Relaxation | Active comparator | Behavioral: Progressive Muscle Relaxation (PMR) |
| Clinical Massage Therapy | Active comparator | Procedure: Clinical Massage Therapy (CMT) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a visit with the physician during the 4-week study referral period for that practice
- Be 21 years of age or older on the date of the visit
- According to the physician, currently have CLBP
- Have been a patient in the practice for at least 3 months
- Have a life expectancy of 6 months or more
Key exclusion criteria (2 listed)
- Not have a current or past history of psychosis
- Not be pregnant
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 |
|---|---|---|
| Progressive Muscle Relaxation (PMR)Progressive Muscle Relaxation (PMR) will be recorded on PDAs integrated with EMA software and offered to patients who will be instructed in the techniques and PDA use by study coordinators. They will be instructed to practice 25 minutes/day the first two weeks, 35 minutes/day weeks 3 and 4, and 45 minutes/day weeks 5 through 12. These time periods (25/35/45 minute) were selected to allow a more gradual acclimation to PMR. | Behavioural | Progressive Muscle Relaxation |
| Clinical Massage Therapy (CMT)PCPs will have the opportunity to refer patients with CLBP to local Licensed Massage Therapists (LMTs) to receive up to 10 clinical massage sessions over a 12-week period. CMT will be provided at no cost to the patients. At their first two sessions, the LMT will evaluate the patient and, with the patient, estimate the number of sessions and determine treatment goals. Based on previous literature, 10 sessions are anticipated over an average 12-week period. However, treatment will vary depending on assessment and progress. At the end of the treatment period, the patients will receive a list of all participating LMTs to facilitate patients' continued or future participation in massage therapy. | Procedure or surgery | Clinical Massage Therapy |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: Baseline, 12 Weeks, and 24 Weeks
Survey completed at Baseline, 12 Weeks, and 24 Weeks
Short Form 36 (SF-36)
Time frame: Baseline, 12 Weeks, and 24 Weeks
Health related quality of life survey
Faces Pain Scale - Revised (FPS-R)
Time frame: Baseline, 12 Weeks, and 24 Weeks
Survey
6 secondary outcomes
Pain Medication Questionnaire (PMQ) - subset
Time frame: Baseline, 12 Weeks, and 24 Weeks
Expectations for and Satisfaction with Therapies
Time frame: Baseline and 12 Weeks
Tampa Scale of Kinesiophobia (TSK) - Subset
Time frame: Baseline, 12 Weeks, and 24 Weeks
Patient Perceptions of CAM Therapy
Time frame: Baseline, 12 Weeks, and 24 Weeks
Physician Perceptions of CAM Therapy
Time frame: Baseline
Physician Point-of-Care Card
Time frame: 4 weeks per practice (Identify and screen for possible patients)
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 4 Jun 2014.
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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.
William G Elder, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation (PMR) and Clinical Massage Therapy (CMT) in people with Low Back Pain, run by William G Elder JR 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 5 inclusion and 2 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 4 Jun 2014. 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?
Oswestry Disability Index (ODI) (time frame: Baseline, 12 Weeks, and 24 Weeks). The study lists 3 primary outcomes in all. 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 4 Jun 2014.