Acute Low Back PainPhase 2NCT00000418
Psychosocial Treatment for Acute Low Back Pain
A Phase 2 study testing Psychosocial intervention in people with Acute Low Back Pain, run by Indiana University at 1 site in United States.
Trial summary
Acute low back pain (severe pain that comes on suddenly and lasts a relatively short time) is very common in the United States, and accounts for substantial illness, functional limitations, pain, and health care costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Low Back Pain
- What is being tested?
- Psychosocial intervention
- Type of treatment
- Surgery or procedure
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1977to Mar 2001
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute low back pain
Who cannot join
- Chronic back pain (including surgery)
- Disability claim for back pain
- Nursing home resident
- Severe impairment in hearing, vision, or speech
- Unable to speak English
- Severe comorbidity
- Unable to contact by phone
- Excluded by primary care physician
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
Official title: Psychosocial Intervention for Acute Low Back Pain (ALBP)
Acute low back pain (severe pain that comes on suddenly and lasts a relatively short time) is very common in the United States, and accounts for substantial illness, functional limitations, pain, and health care costs. This study looks at whether a program designed to improve self-efficacy (a person's belief in his or her ability to reach a goal, such as managing one's own disease) and social support improves the health status of people with acute low back pain.
Read the detailed description
Acute low back pain (ALBP) is very prevalent in the United States, accounting for substantial morbidity, functional limitations, pain, and health care costs. Psychosocial interventions that target improved symptom control and patient functioning have the potential to improve the outcomes of patients with ALBP. This study evaluates a psychosocial intervention designed to enhance self-efficacy and social support for patients with ALBP.
In this randomized, controlled trial, we will randomize eligible patients with ALBP to receive the intervention or usual care. The intervention program consists of: (1) patient education regarding ALBP; (2) explanations and rationales, in layperson's terms, of diagnostic and treatment options for ALBP; (3) discussions regarding the management of negative affect (i.e., depression, anger, fear, hostility, anxiety); (4) methods to involve social support systems; and (5) strategies to involve the primary care physician to reinforce patients' behaviors and progress. We will follow patients for 12 months and assess outcomes at 3 and 12 months.
Primary outcomes are health-related quality of life (i.e., functional status, role function, back pain symptoms) and patient satisfaction with care. Secondary outcomes include health care use, direct health care costs, self-efficacy, and social support. We will also estimate the cost-effectiveness of the intervention.
We will conduct this investigation among socioeconomically vulnerable patients with ALBP, a group that shoulders a disproportionate burden of disability and morbidity from musculoskeletal conditions and comorbid medical conditions.
- Conditions
- Acute Low Back Pain
- Being tested
- Psychosocial intervention
- Keywords
- OA, Patient education, Acute low back pain (ALBP), Social support systems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial interventionProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startSep 1977
- Study completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute Low Back PainStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Enrolment
- 211 participants
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Morris Weinberger, Ph.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000418
- Sponsor's protocol ID
- P60 AR20582 Substudy EEHSR4
- Other IDs
- P60AR020582, NIAMS-025
- Status last verified
- Jun 1999
- First submitted
- 3 Nov 1999
- Last updated
- 6 Jun 2013
- Results posted
- No
Publications
Damush TM, Weinberger M, Clark DO, Tierney WM, Rao JK, Perkins SM, Verel K. Acute low back pain self-management intervention for urban primary care patients: rationale, design, and predictors of participation. Arthritis Rheum. 2002 Aug;47(4):372-9. doi: 10.1002/art.10382.
PubMed 12209482Damush TM, Weinberger M, Perkins SM, Rao JK, Tierney WM, Qi R, Clark DO. Randomized trial of a self-management program for primary care patients with acute low back pain: short-term effects. Arthritis Rheum. 2003 Apr 15;49(2):179-86. doi: 10.1002/art.10995.
PubMed 12687508Damush, Weinberger, Perkins, Rao, Tierney, Qi, & Clark. The cost-effectiveness of a self-management program for primary care patients with acute low back pain. 2002. In preparation.
Damush TM, Weinberger M, Tierney WM, Rao JK, Clark DO, & Perkins SM. A randomized trial of a self-management program for primary care patients with acute low back pain: 12-month outcomes. Poster presented at the annual meeting of the American College of Rheumatology, San Francisco, CA. Arthritis & Rheumatism. 2001;44:S206.
Damush TM, Weinberger M, Tierney WM, Rao JK, Clark DO, & Perkins SM. A randomized trial of a self-management program for primary care patients with acute low back pain: 4-month outcomes. Poster presented at the annual meeting of the American College of Rheumatology, Philadelphia, PA. Arthritis & Rheumatism. 2000;43:S9.
Damush TM, Weinberger M, Tierney WM, Rao J, Clark DO, Adams K, Perkins S, & Emsley C. A comparison between older and younger adults with acute low back pain on functional status and self-management. Poster presented at the annual meeting of the Gerontological Society of America, San Francisco, CA. The Gerontologist. 1999;39:S571.
Damush TM, Weinberger M, Perkins SM, Rao JK, Tierney WM, Qi R, Clark DO. The long-term effects of a self-management program for inner-city primary care patients with acute low back pain. Arch Intern Med. 2003 Nov 24;163(21):2632-8. doi: 10.1001/archinte.163.21.2632.
PubMed 14638564Gameza VA, Bell Lybecker M, Wara P. Laparoscopic Keyhole Versus Sugarbaker Repair in Parastomal Hernia: A Long-Term Case-Controlled Prospective Study of Consecutive Patients. J Laparoendosc Adv Surg Tech A. 2020 Jul;30(7):783-789. doi: 10.1089/lap.2020.0074. Epub 2020 Mar 27.
PubMed 32216697
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Intervention for Acute Low Back Pain (ALBP)
- ClinicalTrials.gov ID
- NCT00000418
- Acronym / sponsor ID
- P60 AR20582 Substudy EEHSR4
- Conditions
- Acute Low Back Pain
- Keywords
- OA, Patient education, Acute low back pain (ALBP), Social support systems
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Sep 1977
- Study completion
- Mar 2001
- First posted
- 4 Nov 1999 (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.
Acute low back pain (severe pain that comes on suddenly and lasts a relatively short time) is very common in the United States, and accounts for substantial illness, functional limitations, pain, and health care costs. This study looks at whether a program designed to improve self-efficacy (a person's belief in his or her ability to reach a goal, such as managing one's own disease) and social support improves the health status of people with acute low back pain.
Detailed description
Acute low back pain (ALBP) is very prevalent in the United States, accounting for substantial morbidity, functional limitations, pain, and health care costs. Psychosocial interventions that target improved symptom control and patient functioning have the potential to improve the outcomes of patients with ALBP. This study evaluates a psychosocial intervention designed to enhance self-efficacy and social support for patients with ALBP.
In this randomized, controlled trial, we will randomize eligible patients with ALBP to receive the intervention or usual care. The intervention program consists of: (1) patient education regarding ALBP; (2) explanations and rationales, in layperson's terms, of diagnostic and treatment options for ALBP; (3) discussions regarding the management of negative affect (i.e., depression, anger, fear, hostility, anxiety); (4) methods to involve social support systems; and (5) strategies to involve the primary care physician to reinforce patients' behaviors and progress. We will follow patients for 12 months and assess outcomes at 3 and 12 months.
Primary outcomes are health-related quality of life (i.e., functional status, role function, back pain symptoms) and patient satisfaction with care. Secondary outcomes include health care use, direct health care costs, self-efficacy, and social support. We will also estimate the cost-effectiveness of the intervention.
We will conduct this investigation among socioeconomically vulnerable patients with ALBP, a group that shoulders a disproportionate burden of disability and morbidity from musculoskeletal conditions and comorbid medical conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute low back pain
Key exclusion criteria (8 listed)
- Chronic back pain (including surgery)
- Disability claim for back pain
- Nursing home resident
- Severe impairment in hearing, vision, or speech
- Unable to speak English
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 |
|---|---|---|
| Psychosocial intervention | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 6 Jun 2013.
- Background: PubMed 12209482Damush TM, Weinberger M, Clark DO, Tierney WM, Rao JK, Perkins SM, Verel K. Acute low back pain self-management intervention for urban primary care patients: rationale, design, and predictors of participation. Arthritis Rheum. 2002 Aug;47(4):372-9. doi: 10.1002/art.10382.
- Background: PubMed 12687508Damush TM, Weinberger M, Perkins SM, Rao JK, Tierney WM, Qi R, Clark DO. Randomized trial of a self-management program for primary care patients with acute low back pain: short-term effects. Arthritis Rheum. 2003 Apr 15;49(2):179-86. doi: 10.1002/art.10995.
- BackgroundDamush, Weinberger, Perkins, Rao, Tierney, Qi, & Clark. The cost-effectiveness of a self-management program for primary care patients with acute low back pain. 2002. In preparation.
- BackgroundDamush TM, Weinberger M, Tierney WM, Rao JK, Clark DO, & Perkins SM. A randomized trial of a self-management program for primary care patients with acute low back pain: 12-month outcomes. Poster presented at the annual meeting of the American College of Rheumatology, San Francisco, CA. Arthritis & Rheumatism. 2001;44:S206.
- BackgroundDamush TM, Weinberger M, Tierney WM, Rao JK, Clark DO, & Perkins SM. A randomized trial of a self-management program for primary care patients with acute low back pain: 4-month outcomes. Poster presented at the annual meeting of the American College of Rheumatology, Philadelphia, PA. Arthritis & Rheumatism. 2000;43:S9.
- BackgroundDamush TM, Weinberger M, Tierney WM, Rao J, Clark DO, Adams K, Perkins S, & Emsley C. A comparison between older and younger adults with acute low back pain on functional status and self-management. Poster presented at the annual meeting of the Gerontological Society of America, San Francisco, CA. The Gerontologist. 1999;39:S571.
- Background: PubMed 14638564Damush TM, Weinberger M, Perkins SM, Rao JK, Tierney WM, Qi R, Clark DO. The long-term effects of a self-management program for inner-city primary care patients with acute low back pain. Arch Intern Med. 2003 Nov 24;163(21):2632-8. doi: 10.1001/archinte.163.21.2632.
- Derived from this study: PubMed 32216697Gameza VA, Bell Lybecker M, Wara P. Laparoscopic Keyhole Versus Sugarbaker Repair in Parastomal Hernia: A Long-Term Case-Controlled Prospective Study of Consecutive Patients. J Laparoendosc Adv Surg Tech A. 2020 Jul;30(7):783-789. doi: 10.1089/lap.2020.0074. Epub 2020 Mar 27.
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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.
Morris Weinberger, Ph.D. principal investigator
Indiana University
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 Psychosocial intervention in people with Acute Low Back Pain, run by Indiana 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 8 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 6 Jun 2013. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000418, which also lists 8 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 6 Jun 2013.