Chronic Musculoskeletal PainPhase 1NCT00861302
Evaluating a Chronic Pain Treatment Program
A Phase 1 study testing Mind-body emotional awareness program in people with Chronic Musculoskeletal Pain, run by Wayne State University at 1 site in United States.
Trial summary
This interventional study seeks to evaluate the overall outcomes of a novel, emotional awareness intervention for people with chronic musculoskeletal pain and determine which patients benefit the most from this intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Musculoskeletal Pain
- What is being tested?
- Mind-body emotional awareness program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Nov 2011
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with chronic musculoskeletal pain, not accounted for by disease or tissue pathology, who are seeking or referred for this psychological treatment program
Who cannot join
- Autoimmune diseases
- Cancer pain
- Illiterate
- Cognitively impaired
- Too medically ill
Trial locations and contacts
1 site in 1 country.
United States1 site
St. John Providence Health System
Southfield, Michigan, 48075
About this study
Official title: Evaluating Outcomes and Response Profiles of a Psychological Treatment for People With Chronic Pain
This interventional study seeks to evaluate the overall outcomes of a novel, emotional awareness intervention for people with chronic musculoskeletal pain and determine which patients benefit the most from this intervention. The investigators also are evaluating the effects of brief emotional communication technique embedded in the pre-treatment assessment.
- Conditions
- Chronic Musculoskeletal Pain
- Being tested
- Mind-body emotional awareness program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-body emotional awareness programBehavioural
This intervention, developed and offered by Dr. Howard Schubiner of St. John Providence Health System, consists of a single individual session with him, followed by four, classroom group sessions. The intervention includes expressive writing, mindfulness, and other techniques designed to enhance awareness and acceptance of the emotional factors underlying the chronic pain problem.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | This is the only group in the study. It consists of patients with chronic musculoskeletal pain who are receiving the treatment program Receives: Behavioral: Mind-body emotional awareness program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory
Measured: baseline, post-treatment, 3- and 6-month follow-ups
Secondary outcomes (5)
Center for Epidemiologic Studies--Depression Scale
Measured: baseline, post-treatment, 3- and 6-month follow-ups
Satisfaction with Life Scale
Measured: baseline, post-treatment, 3- and 6-month follow-ups
McGill Pain Questionnaire
Measured: baseline, post-treatment, 3- and 6-month follow-ups
Impact of Events Scale-Revised
Measured: baseline, post-treatment, 3- and 6-month follow-ups
Positive Affect Negative Affect Scale-Expanded Version
Measured: baseline, post-treatment, 3- and 6-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startSep 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Musculoskeletal 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Responsible party
- Principal investigator, Mark A. Lumley, Wayne State University
- Investigators
- Mark A Lumley, Ph.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861302
- Sponsor's protocol ID
- WSU094808B3E
- Status last verified
- Jun 2012
- First submitted
- 12 Mar 2009
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Burger AJ, Lumley MA, Carty JN, Latsch DV, Thakur ER, Hyde-Nolan ME, Hijazi AM, Schubiner H. The effects of a novel psychological attribution and emotional awareness and expression therapy for chronic musculoskeletal pain: A preliminary, uncontrolled trial. J Psychosom Res. 2016 Feb;81:1-8. doi: 10.1016/j.jpsychores.2015.12.003. Epub 2015 Dec 11.
PubMed 26800632
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Outcomes and Response Profiles of a Psychological Treatment for People With Chronic Pain
- ClinicalTrials.gov ID
- NCT00861302
- Acronym / sponsor ID
- WSU094808B3E
- Conditions
- Chronic Musculoskeletal Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Study start
- Sep 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 13 Mar 2009 (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 interventional study seeks to evaluate the overall outcomes of a novel, emotional awareness intervention for people with chronic musculoskeletal pain and determine which patients benefit the most from this intervention. The investigators also are evaluating the effects of brief emotional communication technique embedded in the pre-treatment assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Mind-body emotional awareness programThis is the only group in the study. It consists of patients with chronic musculoskeletal pain who are receiving the treatment program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with chronic musculoskeletal pain, not accounted for by disease or tissue pathology, who are seeking or referred for this psychological treatment program
Key exclusion criteria (5 listed)
- Autoimmune diseases
- Cancer pain
- Illiterate
- Cognitively impaired
- Too medically ill
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 |
|---|---|---|
| Mind-body emotional awareness programThis intervention, developed and offered by Dr. Howard Schubiner of St. John Providence Health System, consists of a single individual session with him, followed by four, classroom group sessions. The intervention includes expressive writing, mindfulness, and other techniques designed to enhance awareness and acceptance of the emotional factors underlying the chronic pain problem. | Behavioural | Treatment group |
Primary outcome
Brief Pain Inventory
Time frame: baseline, post-treatment, 3- and 6-month follow-ups
5 secondary outcomes
Center for Epidemiologic Studies--Depression Scale
Time frame: baseline, post-treatment, 3- and 6-month follow-ups
Satisfaction with Life Scale
Time frame: baseline, post-treatment, 3- and 6-month follow-ups
McGill Pain Questionnaire
Time frame: baseline, post-treatment, 3- and 6-month follow-ups
Impact of Events Scale-Revised
Time frame: baseline, post-treatment, 3- and 6-month follow-ups
Positive Affect Negative Affect Scale-Expanded Version
Time frame: baseline, post-treatment, 3- and 6-month follow-ups
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 19 Jun 2012.
- Derived from this study: PubMed 26800632Burger AJ, Lumley MA, Carty JN, Latsch DV, Thakur ER, Hyde-Nolan ME, Hijazi AM, Schubiner H. The effects of a novel psychological attribution and emotional awareness and expression therapy for chronic musculoskeletal pain: A preliminary, uncontrolled trial. J Psychosom Res. 2016 Feb;81:1-8. doi: 10.1016/j.jpsychores.2015.12.003. Epub 2015 Dec 11.
Related trials for Chronic Musculoskeletal Pain
Recruiting
Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity
Chronic Low-back Pain, Chronic Pain
Recruiting
Light Bulb Stimuli to Reduce Chronic Pain
Fibromyalgia, Musculoskeletal Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruitingPhase 3
Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia
Breast Cancer, Arthralgia
Not yet recruitingObservational study
Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
Myofascial Pain Syndrome - Neck
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.
Mark A Lumley, Ph.D. principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mind-body emotional awareness program in people with Chronic Musculoskeletal Pain, run by Wayne State 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 1 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 19 Jun 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Brief Pain Inventory (time frame: baseline, post-treatment, 3- and 6-month follow-ups). 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 NCT00861302, which also lists 1 linked publication.
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 19 Jun 2012.