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| Name | Class |
|---|---|
| Health Resources and Services Administration (HRSA) | FED |
| Genesis Family Medical Center | UNKNOWN |
| University of Iowa | OTHER |
| Thomas Jefferson University |
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The purpose of the Collaborative Care for Older Adults with Back Pain (COCOA) Clinical Trial is to evaluate the clinical effectiveness and feasibility of a collaborative care model (medical and chiropractic care) through a pragmatic, prospective pilot trial conducted with 120 older adults over the age of 65 with low back pain of at least 1 month duration.
As America ages, cost-effective care for chronic diseases, such as low back pain, becomes more important. Although estimates vary, 70-85% of Americans will suffer from back pain at some point in their lives. Back pain is well established as one of the most common reasons for seeking care from a medical doctor. The American public also turns to alternative medicine providers, such as doctors of chiropractic, for back pain care. However, few clinical examples and little scientific evidence exist of care coordination between these two provider groups in general, and none that specifically target older adults above the age of 65. The purpose of the Collaborative Care for Older Adults with Back Pain (COCOA) Clinical Trial is to evaluate the clinical effectiveness and feasibility of a collaborative care model (medical and chiropractic care) through a pragmatic, prospective pilot trial conducted with 120 older adults over the age of 65 with low back pain of at least 1 month duration. Participants will be randomized to 3-parallel treatment arms: a) conventional medical care (MED CARE), b) unlinked conventional medical and chiropractic care (DUAL CARE), and c) a co-management model including conventional medical and chiropractic care (SHARED CARE). Participants in all three groups will receive up to 12 weeks of usual back pain treatment from medical doctors or doctors of osteopathy (MD/DO) at Genesis Family Medical Center. Participants in two treatment groups additionally will receive up to 12 weeks of usual chiropractic care for back pain from doctors of chiropractic at the Palmer Research Clinic. Outcomes including pain, disability and secondary outcomes will be measured at 1, 2, and 3 months (primary endpoint) with follow-up assessments completed by telephone at 6, 9, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Care | Active Comparator | Conventional medical care alone |
|
| Dual Care | Active Comparator | Unlinked co-occurrence of conventional medical care and chiropractic care |
|
| Shared Care | Active Comparator | Co-management of medical care and chiropractic care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Care | Other | Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Patient-Rated Low Back Pain (LBP), an 11 Point Numerical Rating Scale (NRS) | Adjusted mean changes in patient-rated LBP from baseline to week 12 were assessed. Average and worst LBP were rated on an 11 Numerical Rating Scale (NRS) point scale (0, no LBP; 10 worst LBP possible) | Baseline and 3 months |
| Change From Baseline in Patient-Rated Disability, the 24-item Roland Morris Disability Questionnaire (RMDQ) | Adjusted mean changes in patient-rated disability from baseline to week 12 were assessed using the 24-item RMDQ where 0 indicated no disability and 24 indicated severe disability. | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Veterans-RAND 36-item Short-Form Health Survey (VR-36) | Physical function and Emotional Well-being (range 0-100). Higher scores indicate a better outcome. | Baseline and 3 months |
| Change From Baseline in Bothersomeness of Low Back Pain Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine M Goertz, DC, PhD | Palmer College of Chiropractic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesis Family Medical Center | Davenport | Iowa | 52803 | United States | ||
| Palmer College of Chiropractic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23324133 | Background | Goertz CM, Salsbury SA, Vining RD, Long CR, Andresen AA, Jones ME, Lyons KJ, Hondras MA, Killinger LZ, Wolinsky FD, Wallace RB. Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial. Trials. 2013 Jan 16;14:18. doi: 10.1186/1745-6215-14-18. | |
| 25344427 |
| Label | URL |
|---|---|
| Collaborative care for a patient with complex low back pain and long-term tobacco use: a case report | View source |
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Feasibility/pilot study
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| ID | Title | Description |
|---|---|---|
| FG000 | Shared Care | Co-management of medical care and chiropractic care Shared Care: Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care. |
| FG001 | Dual Care | Unlinked co-occurrence of conventional medical care and chiropractic care Dual Care: Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided. |
| FG002 | Medical Care | Conventional medical care alone Medical Care: Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Shared Care | Co-management of medical care and chiropractic care Shared Care: Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Patient-Rated Low Back Pain (LBP), an 11 Point Numerical Rating Scale (NRS) | Adjusted mean changes in patient-rated LBP from baseline to week 12 were assessed. Average and worst LBP were rated on an 11 Numerical Rating Scale (NRS) point scale (0, no LBP; 10 worst LBP possible) | 9 participants (shared care, n=2 / Med Care n=7) did not complete the 3 month appointment due to either withdrawal or loss to follow-up. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 3 months |
|
3 months
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Shared Care | Co-management of medical care and chiropractic care Shared Care: Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spine-related pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine M Goertz, DC, PhD (Study Principal Investigator) | Spine Institute for Quality | 301-335-0071 | cgoertz@spineiq.org |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| OTHER |
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Not provided
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|
|
| Dual Care | Other | Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided. |
|
|
| Shared Care | Other | Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care. |
|
|
Adjusted mean changes in patient-reported LBP bothersomeness on a 5 point scale index (1, not at all bothered; 5, extremely bothered) from baseline to week 12 were assessed.
| Baseline to 3 months |
| Patient Satisfaction With Care | Percent of participants reporting levels of satisfaction for the information received regarding the cause of low back pain [LBP] (A), prognosis of LBP (B) and activities that hasten recovery (C), concern of MDs and Doctor of Chiropractic (DCs) during treatments (D), the quality of the treatment recommendations(E) and the overall care for LBP (F) | 3 months |
| Davenport |
| Iowa |
| 52803 |
| United States |
| Vining RD, Salsbury SA, Pohlman KA. Eligibility determination for clinical trials: development of a case review process at a chiropractic research center. Trials. 2014 Oct 24;15:406. doi: 10.1186/1745-6215-15-406. |
| 21174032 | Background | Goertz C, Lyons SS, Andresen A, Hondras M, Jones M, Killinger LZ, Long C, Lyons K, Mulhausen P, Vining R. Collaborative Care for Older Adults (COCOA), Palmer College of Chiropractic. J Allied Health. 2010 Fall;39 Suppl 1:e135-6. |
| 24040970 | Background | Lyons KJ, Salsbury SA, Hondras MA, Jones ME, Andresen AA, Goertz CM. Perspectives of older adults on co-management of low back pain by doctors of chiropractic and family medicine physicians: a focus group study. BMC Complement Altern Med. 2013 Sep 16;13:225. doi: 10.1186/1472-6882-13-225. |
| 26500355 | Background | Seidman MB, Vining RD, Salsbury SA. Collaborative care for a patient with complex low back pain and long-term tobacco use: a case report. J Can Chiropr Assoc. 2015 Sep;59(3):216-25. |
| 29257708 | Background | Boysen JC, Shannon ZK, Khan YA, Wells BM, Vining RD. A graphical clinical decision aid for managing imaging report information. J Chiropr Educ. 2017 Mar;32(1):43-49. doi: 10.7899/JCE-17-6. Epub 2017 Dec 19. |
| 28082277 | Background | Salsbury SA, Goertz CM, Vining RD, Hondras MA, Andresen AA, Long CR, Lyons KJ, Killinger LZ, Wallace RB. Interdisciplinary Practice Models for Older Adults With Back Pain: A Qualitative Evaluation. Gerontologist. 2018 Mar 19;58(2):376-387. doi: 10.1093/geront/gnw188. |
| 31257002 | Background | Salsbury SA, Vining RD, Hondras MA, Wallace RB, Lyons KJ, Killinger LZ, Goertz CM. Interprofessional Attitudes and Interdisciplinary Practices for Older Adults With Back Pain Among Doctors of Chiropractic: A Descriptive Survey. J Manipulative Physiol Ther. 2019 May;42(4):295-305. doi: 10.1016/j.jmpt.2018.11.011. Epub 2019 Jun 27. |
| 33062871 | Background | Wells BM, Salsbury SA, Nightingale LM, Derby DC, Lawrence DJ, Goertz CM. Improper Communication Makes for Squat: A Qualitative Study of the Health-Care Processes Experienced By Older Adults in a Clinical Trial for Back Pain. J Patient Exp. 2020 Aug;7(4):507-515. doi: 10.1177/2374373519860347. Epub 2019 Jul 8. |
| 29029606 | Result | Goertz CM, Salsbury SA, Long CR, Vining RD, Andresen AA, Hondras MA, Lyons KJ, Killinger LZ, Wolinsky FD, Wallace RB. Patient-centered professional practice models for managing low back pain in older adults: a pilot randomized controlled trial. BMC Geriatr. 2017 Oct 13;17(1):235. doi: 10.1186/s12877-017-0624-z. |
| Eligibility determination for clinical trials: development of a case review process at a chiropractic research center | View source |
| Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial | View source |
| Perspectives of older adults on co-management of low back pain by doctors of chiropractic and family medicine physicians: a focus group study | View source |
| Patient-centered professional practice models for managing low back pain in older adults: a pilot randomized controlled trial | View source |
| Improper communication makes for squat: a qualitative study of the health-care processes experienced by older adults in a clinical trial for back pain | View source |
| BG001 | Dual Care | Unlinked co-occurrence of conventional medical care and chiropractic care Dual Care: Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided. |
| BG002 | Medical Care | Conventional medical care alone Medical Care: Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Dual Care | Unlinked co-occurrence of conventional medical care and chiropractic care Dual Care: Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided. |
| OG002 | Medical Care | Conventional medical care alone Medical Care: Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral. |
|
|
| Primary | Change From Baseline in Patient-Rated Disability, the 24-item Roland Morris Disability Questionnaire (RMDQ) | Adjusted mean changes in patient-rated disability from baseline to week 12 were assessed using the 24-item RMDQ where 0 indicated no disability and 24 indicated severe disability. | 9 participants (shared care, n=2 / Med Care n=7) did not complete the 3 month appointment due to either withdrawal or loss to follow-up. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 3 months |
|
|
|
| Secondary | Veterans-RAND 36-item Short-Form Health Survey (VR-36) | Physical function and Emotional Well-being (range 0-100). Higher scores indicate a better outcome. | 9 participants (shared care, n=2 / Med Care n=7) did not complete the 3 month appointment due to either withdrawal or loss to follow-up. | Posted | Mean | Standard Deviation | units on a scale (0-100) | Baseline and 3 months |
|
|
|
| Secondary | Change From Baseline in Bothersomeness of Low Back Pain Symptoms | Adjusted mean changes in patient-reported LBP bothersomeness on a 5 point scale index (1, not at all bothered; 5, extremely bothered) from baseline to week 12 were assessed. | 9 participants (shared care, n=2 / Med Care n=7) did not complete the 3 month appointment due to either withdrawal or loss to follow-up. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 3 months |
|
|
|
| Secondary | Patient Satisfaction With Care | Percent of participants reporting levels of satisfaction for the information received regarding the cause of low back pain [LBP] (A), prognosis of LBP (B) and activities that hasten recovery (C), concern of MDs and Doctor of Chiropractic (DCs) during treatments (D), the quality of the treatment recommendations(E) and the overall care for LBP (F) | 9 participants (shared care, n=2 / Med Care n=7) did not complete the 3 month appointment due to either withdrawal or loss to follow-up. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 34 |
| 44 |
| EG001 | Dual Care | Unlinked co-occurrence of conventional medical care and chiropractic care Dual Care: Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided. | 0 | 44 | 0 | 44 | 36 | 44 |
| EG002 | Medical Care | Conventional medical care alone Medical Care: Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral. | 0 | 43 | 0 | 43 | 10 | 43 |
| Spine-related pain with radiation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Extremity pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| General stiffness/tightness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle spasm/cramp | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Numbness/tingling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| General soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Pulmonary hypertension | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Shortness of breath | Cardiac disorders | Systematic Assessment |
|
| Angina | Cardiac disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Tiredness/fatigue | General disorders | Systematic Assessment |
|
| Dizziness/imbalance/vertigo | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Upper respiratory infection | General disorders | Systematic Assessment |
|
| Lower respiratory infection | General disorders | Systematic Assessment |
|
| Sinus congestion/respiratory symptoms/allergy | General disorders | Systematic Assessment |
|
| Migraine | General disorders | Systematic Assessment |
|
| Abdominal pain | General disorders | Systematic Assessment |
|
| Laceration | General disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
| Diarrhea | General disorders | Systematic Assessment |
|
| General soreness | General disorders | Systematic Assessment |
|
| Chipped tooth | General disorders | Systematic Assessment |
|
| Allergic rash | General disorders | Systematic Assessment |
|
| Shortness of breath | General disorders | Systematic Assessment |
|
| Cold sore | General disorders | Systematic Assessment |
|
| Fall | General disorders | Systematic Assessment |
|
| Skin burning sensation | General disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Tremor | General disorders | Systematic Assessment |
|
| Constipation | General disorders | Systematic Assessment |
|
| GERD | General disorders | Systematic Assessment |
|
| Skin allergic reaction | General disorders | Systematic Assessment |
|
| Cough | General disorders | Systematic Assessment |
|
| Concussion | General disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
|
| Emotional Well-Being - Baseline |
|
| Emotional Well-Being - 3 Months |
|
| Good |
|
| Very Good |
|
| Excellent |
|
| (B) Prognosis of LBP |
|
| (C) Activities that hasten recovery |
|
| (D) Concern of MDs and DCs during recovery |
|
| (E) Quality of treatment recommendations |
|
| (F) Overall Care for LBP |
|