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| ID | Type | Description | Link |
|---|---|---|---|
| RX003485-01A1 | Other Grant/Funding Number | VA-ORD |
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Chronic pain is very common among primary care Veterans and can seriously impact overall patient functioning and well-being. Currently, behavioral treatments for pain management are not often provided in primary care because they are designed to be delivered in specialty care settings, such as chronic pain clinics. To address this gap in care, the proposed study will test if Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) is an effective treatment. Therefore, the first objective of the proposed study is to conduct a randomized controlled trial of Brief CBT-CP compared to primary care treatment as usual to assess treatment effectiveness by examining changes in pain-related physical activity interference, psychological distress, pain intensity, and other related outcomes. 178 eligible participants will be randomized into either Brief CBT-CP and primary care treatment as usual or primary care treatment as usual only. Eligible Veterans will include those with chronic musculoskeletal pain and pain-related functional impairment identified from primary care. Participants assigned to Brief CBT-CP will receive six sessions of treatment in 30-minute appointments. This intervention will include education and goal setting, activities and pacing, relaxation skills, cognitive coping, and relapse prevention. Assessments will include validated self-report measures that will take place at pre-treatment (baseline), mid-treatment, post-treatment, and at 6-month follow-up. The second objective of this study is examine the mechanisms by which Brief CBT-CP leads to improvement in patient outcomes. Statistical analysis will reveal if changes pain self-efficacy (i.e., perceived ability to manage pain or engage in usual activities despite being in pain) and catastrophizing (i.e., unhelpful, negative though patterns about pain and pain management) lead to improvements in patient functioning. The third objective of this study will be to explore perceptions of Brief CBT-CP among patients who experience significant improvement in outcomes compared to those who did not experience improvement. Participants will include up to 40 patients who were treated with Brief CBT-CP. Participants will be interviewed about key components of the treatment and their perception of effectiveness. Interview data will be compared to the results of statistical analysis to help understand the mechanisms by which Brief CBT-CP is effective or identify areas for improvement. Results of this study will provide information needed to determine if Brief CBT-CP should be widely disseminated across VA primary care clinics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief CBT for Chronic Pain and treatment as usual | Experimental | Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 weeks. Session one focuses on foundational pain education and the development of treatment goals. Session two emphasizes balanced engagement in physical activity and pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment. |
|
| Treatment as usual only | Other | Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief CBT for Chronic Pain | Behavioral | Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 weeks. Session one focuses on foundational pain education and the development of treatment goals. Session two emphasizes balanced engagement in physical activity and pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory -- Interference Subscale (BPI-I) to Assess 12 Week Follow-up | This measure is a validated 7-item subscale that evaluates pain-related interference in daily activities and social and occupational functioning. Average scores range from 0 to 10, with higher scores indicating higher pain-related interference. | 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory -- Pain Intensity Subscale (BPI-P) to Assess 12 Week Follow-up | This measure is a validated 4-item subscale that evaluates pain intensity. Average scores range from 0 to 10, with higher scores indicating worse pain intensity. | 12-weeks |
| Patient Health Questionnaire -- 9 (PHQ-9) to Assess 12 Week Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
Current or prior (past 12 months) engagement in psychotherapy or behavioral intervention provided by behavioral medicine services or specialty mental health for chronic pain.
Endorsement of imminent suicide risk
Current significant substance use problems (i.e., alcohol, opioids, benzodiazepines, or other drugs)
Unstable psychiatric status (e.g., active psychosis, current mania)
Diagnosed with major or minor neurocognitive disorder
Unwilling to have treatment sessions audio recorded
Pending disability claim
Recent or planned surgical/interventional procedure for pain
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| Name | Affiliation | Role |
|---|---|---|
| Gregory P. Beehler, PhD | VA Western New York Healthcare System, Buffalo, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Western New York Healthcare System, Buffalo, NY | Buffalo | New York | 14215-1129 | United States |
A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. The LDS will contain IPD that underlie results presented in publications.
IPD will be made available for up to three years starting six months after final publication.
Data will be shared upon completion of a written request and within 90 days of a completed Data Use Agreement (DUA).
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| ID | Title | Description |
|---|---|---|
| FG000 | Brief CBT for Chronic Pain and Treatment as Usual | Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 weeks. Session one focuses on foundational pain education and the development of treatment goals. Session two emphasizes balanced engagement in physical activity and pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment. |
| FG001 | Treatment as Usual Only | Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Brief CBT for Chronic Pain and Treatment as Usual | Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 weeks. Session one focuses on foundational pain education and the development of treatment goals. Session two emphasizes balanced engagement in physical activity and pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment. |
| 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 | Brief Pain Inventory -- Interference Subscale (BPI-I) to Assess 12 Week Follow-up | This measure is a validated 7-item subscale that evaluates pain-related interference in daily activities and social and occupational functioning. Average scores range from 0 to 10, with higher scores indicating higher pain-related interference. | Posted | Mean | Standard Error | score on instrument | 12-weeks |
|
Enrollment to 12 week follow-up
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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 | Brief CBT for Chronic Pain and Treatment as Usual | Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 weeks. Session one focuses on foundational pain education and the development of treatment goals. Session two emphasizes balanced engagement in physical activity and pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Evaluation for CVA | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory Beehler, PhD, MA | VA Center for Integrated Healthcare | 716-862-7934 | gregory.beehler@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2024 | Jan 12, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 20, 2024 | Oct 22, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Two arm parallel design: 1) primary care treatment as usual, or 2) primary care treatment as usual and Brief Cognitive Behavioral Therapy for Chronic Pain
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Only the outcomes assessor will be masked
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|
| Treatment as usual | Other | Participants assigned to TAU will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated. |
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|
This 9-item measure of depressive symptoms is validated for use in primary care. Total scores range from 0 to 27, with higher scores indicating more depression symptoms. |
| 12-weeks |
| World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Physical Health at 12 Week Follow up | This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain. | 12-weeks |
| World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Psychological Quality of Life at 12 Week Follow up | This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain. | 12-weeks |
| World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Social Relationships at 12 Week Follow up | This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain. | 12-weeks |
| World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Environmental Health at 12 Week Follow up | This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain. | 12-weeks |
| Ability to Participate in Social Roles and Activities - Short Form (APSRA) to Assess 12 Week Follow up | This 8-item measure was developed to evaluate one's perceived ability to perform usual social roles and activities. Total scores range from eight to 40, with higher scores indicating better ability to participate in usual activities. | 12-weeks |
| BG001 | Treatment as Usual Only | Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Brief Pain Inventory -- Interference subscale (BPI-I) | This measure is a validated 7-item subscale that evaluates pain-related interference in daily activities and social and occupational functioning. Average scores range from 0 to 10, with higher scores indicating higher pain-related interference. | Mean | Standard Deviation | score on a measure |
|
| Brief Pain Inventory -- Pain Intensity subscale (BPI-P) | This measure is a validated 4-item subscale that evaluates pain intensity. Average scores range from 0 to 10, with higher scores indicating worse pain intensity. | Mean | Standard Deviation | score on a measure |
|
| Patient Health Questionnaire -- 9 (PHQ-9) | This 9-item measure of depressive symptoms is validated for use in primary care. Total scores range from 0 to 27, with higher scores indicating more depression symptoms. | Mean | Standard Deviation | score on a measure |
|
| World Health Organization Quality of Life - BREF (WHOQOL-BREF) to assess physical quality of life | This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain. | Mean | Standard Deviation | score on a measure |
|
| World Health Organization Quality of Life - BREF (WHOQOL-BREF) to assess psychological health | This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain. | Mean | Standard Deviation | score on measure |
|
| World Health Organization Quality of Life - BREF (WHOQOL-BREF) to assess social quality of life | This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain. | Mean | Standard Deviation | score on a measure |
|
| World Health Organization Quality of Life - BREF (WHOQOL-BREF) to assess environmental quality of li | This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain. | Mean | Standard Deviation | score on a measure |
|
| Ability to Participate in Social Roles and Activities - short form (APSRA) | This 8-item measure was developed to evaluate one's perceived ability to perform usual social roles and activities. Total scores range from eight to 40, with higher scores indicating better ability to participate in usual activities. | Mean | Standard Deviation | Score on a measure |
|
| OG001 | Treatment as Usual Only | Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated. |
|
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| Secondary | Brief Pain Inventory -- Pain Intensity Subscale (BPI-P) to Assess 12 Week Follow-up | This measure is a validated 4-item subscale that evaluates pain intensity. Average scores range from 0 to 10, with higher scores indicating worse pain intensity. | Posted | Mean | Standard Error | score on intstrument | 12-weeks |
|
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|
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| Secondary | Patient Health Questionnaire -- 9 (PHQ-9) to Assess 12 Week Follow-up | This 9-item measure of depressive symptoms is validated for use in primary care. Total scores range from 0 to 27, with higher scores indicating more depression symptoms. | Posted | Mean | Standard Error | score on instrument | 12-weeks |
|
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| Secondary | World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Physical Health at 12 Week Follow up | This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain. | Posted | Mean | Standard Error | score on measure | 12-weeks |
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| Secondary | World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Psychological Quality of Life at 12 Week Follow up | This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain. | Posted | Mean | Standard Error | score on a measure | 12-weeks |
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| Secondary | World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Social Relationships at 12 Week Follow up | This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain. | Posted | Mean | Standard Error | score on a measure | 12-weeks |
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| Secondary | World Health Organization Quality of Life - BREF (WHOQOL-BREF) to Assess Environmental Health at 12 Week Follow up | This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions. Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment). Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain. | Posted | Mean | Standard Error | score on a measure | 12-weeks |
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| Secondary | Ability to Participate in Social Roles and Activities - Short Form (APSRA) to Assess 12 Week Follow up | This 8-item measure was developed to evaluate one's perceived ability to perform usual social roles and activities. Total scores range from eight to 40, with higher scores indicating better ability to participate in usual activities. | Posted | Mean | Standard Error | score on instrument | 12-weeks |
|
|
|
|
| 0 |
| 92 |
| 2 |
| 92 |
| 12 |
| 92 |
| EG001 | Treatment as Usual Only | Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated. | 0 | 92 | 4 | 92 | 10 | 92 |
| Rib fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Admitted for persistent cough and sore throat | Infections and infestations | Systematic Assessment |
|
| Admitted for evaluation of syncope | Nervous system disorders | Systematic Assessment |
|
| Admitted for abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Ankle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Arm pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Elevated blood sugar | Metabolism and nutrition disorders | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Acute bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Injuries due to assault | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Foot pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Abdominal pain and cramping | Gastrointestinal disorders | Systematic Assessment |
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| Tooth abscess | Infections and infestations | Systematic Assessment |
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| Cellulitus | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| D013568 | Pathological Conditions, Signs and Symptoms |