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Given the modest effectiveness of current treatments and the burden chronic neck pain places on Veterans, the investigators' research proposal is significant in several regards. First, Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated (TOMCATT) Study directly addresses a high priority area for the VA and is well aligned with the VHA Pain Management Strategy and VHA Pain Management Directive 2009-053. Second, because previous massage studies have included relatively small sample sizes, this trial will provide information vital to fill an evidence vacuum regarding effectiveness of a massage treatments for chronic neck pain. Third, TOMCATT will extend the current understanding of non-pharmacological treatments. Fourth, if the study hypotheses are corroborated massage may emerge as an effective, safe, affordable, sustainable, and accessible treatment for Veterans.
Background: Neck pain is the fourth leading cause of disability in the US, after back pain, depression, and joint pain, and accounts for more than 10 million medical visits per year. Conventional treatments (medications, physical therapy) are widely used for chronic neck pain, yet have modest effectiveness and may carry risks, such as the toxicities associated with non-steroidal anti-inflammatory drugs (NSAIDs) and opioids. As a result many patients live with chronic, often debilitating, pain. Patients unable to find relief frequently turn to complementary health approaches. Complementary therapies are exceptionally popular among Veterans; 82% reported use of at least one complementary therapy and nearly all (99%) were willing to try massage for pain relief. Neck pain is the second most common reason for using a complementary therapy, with massage used for neck pain more commonly than all other complementary therapies except chiropractic care. Of all complementary approaches, massage was the most preferred by Veterans. In a national survey, almost two-thirds (61%) of individuals with neck pain who used both complementary and conventional treatments perceived complementary to be more helpful, whereas only 6% perceived conventional treatments to be better.
Objectives: The Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated (TOMCATT) Study is a 2-arm, parallel group, randomized clinical trial that will last 6 months. The TOMCATT Study will target 264 Veterans with chronic neck pain and will compare therapist-treated massage to a waitlist control arm on primary, secondary, and exploratory outcomes. There was previously an additional group staff randomized 102 Veterans and their Care Allies to, but are no longer randomizing into this group.
Methods: This study sample will include 264 Veterans with chronic neck pain. Patients from the 5 primary care clinics at the Roudebush VA Medical Center (RVAMC) and 3 community based outpatient clinics (Terre Haute, Martinsville, and Bloomington) will be recruited to participate. The Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated (TOMCATT) Study will be a 2-arm, parallel group, randomized clinical trial. Eligible participants will be randomized to one of two study arms: 1) Patients in the therapist-treated arm will receive 3 months of twice weekly massage delivered by certified massage therapists. The second and comparator arm will be a waitlist control. The trial will last 6 months and compare therapist-delivered massage to control on neck pain outcomes. The investigators will compare changes in pain-related disability (primary outcome) between the two groups (Aim 1) and examine secondary outcomes: pain severity, quality of life, depression, anxiety, and stress (Aim 2) as well as exploratory outcomes. To examine the implementation potential of the intervention, including facilitators and barriers, the investigators will conduct post-study, in-depth qualitative interviews of a subsample of study participants (Veteran patients and caregivers) the massage group and the no-longer enrolling CAM group(Aim 3). Lastly, the investigators will assess treatment fidelity and compare the relative intervention costs and budget impact for both interventions. The intervention period will last for 3 months, after which time Veterans will be followed for an additional 3 months.
Innovation: The TOMCATT Study is a novel extension of the investigators' prior work, has strong implementation potential, and innovates by placing caregivers in a treatment delivery role that has the potential to reach a greater number of Veterans with chronic neck pain while also producing substantial cost-savings. Although studies have shown that massage is effective for pain, caregiver-delivered strategies have not been tested or implemented in any systematic way across VA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapist treated massage (TT-M) | Experimental | Participants randomized to the therapist-treated massage (TT-M) arm will receive a standardized Swedish massage protocol tailored to chronic neck pain. Massage sessions will involve a maximum of 60 minutes of hands-on, table time and occur twice a week (a frequency which balances practicality and efficacy) for 3 months. |
|
| Wait list control (WL-C) | No Intervention | Participants in the waitlist control will be instructed to continue their medical care as normal and to not begin any massage treatment during the 6 months of the study. At the competition of the final 6 month outcome, participants in the control arm will be eligible to attend a caregiver training session and receive a complementary massage session from a TOMCATT study therapist. | |
| Care ally assisted massage (CA-M) | Experimental | CA-M consisted of in-person training for veteran/care-ally dyads to learn a standardized 30-minue massage routine, instructional DVD, and printed treatment manual. Participants were to complete three care ally-assisted massage sessions weekly for 12-weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapist treated massage | Other | Participants randomized to the therapist-treated massage (TT-M) arm will receive a standardized Swedish massage protocol tailored to chronic neck pain. Massage sessions will involve a maximum of 60 minutes of hands-on, table time and occur twice a week (a frequency which balances practicality and efficacy) for 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Neck Disability Index | The NDI is the standard instrument for measuring self-rated disability due to neck pain. The NDI was developed as a modification of the well-validated Oswestry Low Back Pain Disability Index. The NDI consists of 10-items that assess pain and functioning. All items are framed as a "problem right now" and are scored on a 6-point numeric rating scores of 0 to 5, with 5 being "worst." The total score ranges from 0 to 50, with higher scores representing greater disability from chronic neck pain. The NDI has strong internal consistency (Cronbach's alpha = 0.80) and construct validity. Scoring of the NDI involves: 1) summing the score for each item (raw score); or 2) raw score can be multiplied by 2 to produce a percentage score. The following scoring intervals aid interpretation: 0 - 4 = no disability; 5 - 14 = mild; 15 - 24 = moderate; 25 - 34 = severe; and > 34 = complete disability. At least a 5-point change is defined as "clinically meaningful." | Baseline |
| Neck Disability Index | The NDI is the standard instrument for measuring self-rated disability due to neck pain. The NDI was developed as a modification of the well-validated Oswestry Low Back Pain Disability Index. The NDI consists of 10-items that assess pain and functioning. All items are framed as a "problem right now" and are scored on a 6-point numeric rating scores of 0 to 5, with 5 being "worst." The total score ranges from 0 to 50, with higher scores representing greater disability from chronic neck pain. The NDI has strong internal consistency (Cronbach's alpha = 0.80) and construct validity. Scoring of the NDI involves: 1) summing the score for each item (raw score); or 2) raw score can be multiplied by 2 to produce a percentage score. The following scoring intervals aid interpretation: 0 - 4 = no disability; 5 - 14 = mild; 15 - 24 = moderate; 25 - 34 = severe; and > 34 = complete disability. At least a 5-point change is defined as "clinically meaningful." | 1 Month |
| Neck Disability Index | The NDI is the standard instrument for measuring self-rated disability due to neck pain. The NDI was developed as a modification of the well-validated Oswestry Low Back Pain Disability Index. The NDI consists of 10-items that assess pain and functioning. All items are framed as a "problem right now" and are scored on a 6-point numeric rating scores of 0 to 5, with 5 being "worst." The total score ranges from 0 to 50, with higher scores representing greater disability from chronic neck pain. The NDI has strong internal consistency (Cronbach's alpha = 0.80) and construct validity. Scoring of the NDI involves: 1) summing the score for each item (raw score); or 2) raw score can be multiplied by 2 to produce a percentage score. The following scoring intervals aid interpretation: 0 - 4 = no disability; 5 - 14 = mild; 15 - 24 = moderate; 25 - 34 = severe; and > 34 = complete disability. At least a 5-point change is defined as "clinically meaningful." |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory (BPI) | The Brief Pain Inventory is an 11-item, multidimensional pain measurement tool with reliability in patients with arthritis as well as other pain conditions. The BPI rates the intensity of pain as well as the interference of pain with mood, physical activity, work, social activity, relations, sleep, and enjoyment of life. The BPI has a score range from 0-10 with higher scores representing more severe pain and more pain interference. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J. Bair, MD MS | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana | 46202-2803 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36166287 | Result | Munk N, Daggy JK, Evans E, Kline M, Slaven JE, Laws B, Foote T, Matthias MS, Bair MJ. Therapist-Delivered Versus Care Ally-Assisted Massage for Veterans With Chronic Neck Pain: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Sep 27;11(9):e38950. doi: 10.2196/38950. | |
| 40875586 | Derived | Munk N, Daggy JK, Slaven JE, Foote T, Garner M, Evans E, Laws BV, Matthias MS, Bair MJ. Therapist delivered massage for Veterans with chronic neck pain: a randomized control trial. Pain Med. 2026 Feb 1;27(2):160-169. doi: 10.1093/pm/pnaf118. |
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395 participants were enrolled but 102 randomized to CA-M and not included in the final analysis. Due to high attrition in CA-M (62/98, 63.2%), TOMCATT was modified into a two-arm study (TT-M, WL-C). Three participants were withdrawn post-randomization: one consent revoked and two COVID re-randomizations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Therapist Treated Massage (TT-M) | Participants randomized to the therapist-treated massage (TT-M) arm will receive a standardized Swedish massage protocol tailored to chronic neck pain. Massage sessions will involve a maximum of 60 minutes of hands-on, table time and occur twice a week (a frequency which balances practicality and efficacy) for 3 months. Therapist treated massage: Participants randomized to the therapist-treated massage (TT-M) arm will receive a standardized Swedish massage protocol tailored to chronic neck pain. Massage sessions will involve a maximum of 60 minutes of hands-on, table time and occur twice a week (a frequency which balances practicality and efficacy) for 3 months. |
| FG001 | Wait List Control (WL-C) | Participants in the waitlist control will be instructed to continue their medical care as normal and to not begin any massage treatment during the 6 months of the study. At the competition of the final 6 month outcome, participants in the control arm will be eligible to attend a caregiver training session and receive a complementary massage session from a TOMCATT study therapist. |
| FG002 | Care Ally Assisted Massage (CA-M) | CA-M consisted of in-person training for veteran/care-ally dyads to learn a standardized 30-minue massage routine, instructional DVD, and printed treatment manual. Participants were to complete three care ally-assisted massage sessions weekly for 12-weeks. Outcomes collected at baseline, 1-, 3-, and 6- months included validated measures of neck pain severity and associated disability. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Therapist Treated Massage (TT-M) | Participants randomized to the therapist-treated massage (TT-M) arm will receive a standardized Swedish massage protocol tailored to chronic neck pain. Massage sessions will involve a maximum of 60 minutes of hands-on, table time and occur twice a week (a frequency which balances practicality and efficacy) for 3 months. Therapist treated massage: Participants randomized to the therapist-treated massage (TT-M) arm will receive a standardized Swedish massage protocol tailored to chronic neck pain. Massage sessions will involve a maximum of 60 minutes of hands-on, table time and occur twice a week (a frequency which balances practicality and efficacy) for 3 months. |
| 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 | Neck Disability Index | The NDI is the standard instrument for measuring self-rated disability due to neck pain. The NDI was developed as a modification of the well-validated Oswestry Low Back Pain Disability Index. The NDI consists of 10-items that assess pain and functioning. All items are framed as a "problem right now" and are scored on a 6-point numeric rating scores of 0 to 5, with 5 being "worst." The total score ranges from 0 to 50, with higher scores representing greater disability from chronic neck pain. The NDI has strong internal consistency (Cronbach's alpha = 0.80) and construct validity. Scoring of the NDI involves: 1) summing the score for each item (raw score); or 2) raw score can be multiplied by 2 to produce a percentage score. The following scoring intervals aid interpretation: 0 - 4 = no disability; 5 - 14 = mild; 15 - 24 = moderate; 25 - 34 = severe; and > 34 = complete disability. At least a 5-point change is defined as "clinically meaningful." | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
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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 | Therapist Treated Massage (TT-M) | Participants randomized to the therapist-treated massage (TT-M) arm will receive a standardized Swedish massage protocol tailored to chronic neck pain. Massage sessions will involve a maximum of 60 minutes of hands-on, table time and occur twice a week (a frequency which balances practicality and efficacy) for 3 months. Therapist treated massage: Participants randomized to the therapist-treated massage (TT-M) arm will receive a standardized Swedish massage protocol tailored to chronic neck pain. Massage sessions will involve a maximum of 60 minutes of hands-on, table time and occur twice a week (a frequency which balances practicality and efficacy) for 3 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DEATH | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BACK PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Bair, Director of Center for Health Information and Communication | Richard L Roudebush VA Medical Center | 317-988-2058 | Matthew.Bair@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 | Jun 27, 2022 | Feb 27, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 27, 2022 | Feb 28, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D059350 | Chronic Pain |
| D010146 | Pain |
| D001168 | Arthritis |
| D059352 | Musculoskeletal Pain |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
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|
|
| Care ally assisted massage | Other | CA-M consisted of in-person training for veteran/care-ally dyads to learn a standardized 30-minue massage routine, instructional DVD, and printed treatment manual. Participants were to complete three care ally-assisted massage sessions weekly for 12-weeks. |
|
|
| 3 Month |
| Neck Disability Index | The NDI is the standard instrument for measuring self-rated disability due to neck pain. The NDI was developed as a modification of the well-validated Oswestry Low Back Pain Disability Index. The NDI consists of 10-items that assess pain and functioning. All items are framed as a "problem right now" and are scored on a 6-point numeric rating scores of 0 to 5, with 5 being "worst." The total score ranges from 0 to 50, with higher scores representing greater disability from chronic neck pain. The NDI has strong internal consistency (Cronbach's alpha = 0.80) and construct validity. Scoring of the NDI involves: 1) summing the score for each item (raw score); or 2) raw score can be multiplied by 2 to produce a percentage score. The following scoring intervals aid interpretation: 0 - 4 = no disability; 5 - 14 = mild; 15 - 24 = moderate; 25 - 34 = severe; and > 34 = complete disability. At least a 5-point change is defined as "clinically meaningful." | 6 Month |
| Baseline |
| Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36) | Health-related quality of life will be measured with the VR-36, a modified version of the Medical Outcomes Study SF-36 widely used in VA research and available in the public domain. Internal consistency is high. The VR-36 is scored 0-100 with higher scores representing improved health related quality of life. | Baseline |
| Brief Pain Inventory (BPI) | The Brief Pain Inventory is an 11-item, multidimensional pain measurement tool with reliability in patients with arthritis as well as other pain conditions. The BPI rates the intensity of pain as well as the interference of pain with mood, physical activity, work, social activity, relations, sleep, and enjoyment of life. The BPI has a score range from 0-10 with higher scores representing more severe pain and more pain interference. | 1 Month |
| Brief Pain Inventory (BPI) | The Brief Pain Inventory is an 11-item, multidimensional pain measurement tool with reliability in patients with arthritis as well as other pain conditions. The BPI rates the intensity of pain as well as the interference of pain with mood, physical activity, work, social activity, relations, sleep, and enjoyment of life. The BPI has a score range from 0-10 with higher scores representing more severe pain and more pain interference. | 3 Month |
| Brief Pain Inventory (BPI) | The Brief Pain Inventory is an 11-item, multidimensional pain measurement tool with reliability in patients with arthritis as well as other pain conditions. The BPI rates the intensity of pain as well as the interference of pain with mood, physical activity, work, social activity, relations, sleep, and enjoyment of life. The BPI has a score range from 0-10 with higher scores representing more severe pain and more pain interference. | 6 Month |
| Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36) | Health-related quality of life will be measured with the VR-36, a modified version of the Medical Outcomes Study SF-36 widely used in VA research and available in the public domain. Internal consistency is high. The VR-36 is scored 0-100 with higher scores representing improved health related quality of life. | 1 Month |
| Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36) | Health-related quality of life will be measured with the VR-36, a modified version of the Medical Outcomes Study SF-36 widely used in VA research and available in the public domain. Internal consistency is high. The VR-36 is scored 0-100 with higher scores representing improved health related quality of life. | 3 Month |
| Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36) | Health-related quality of life will be measured with the VR-36, a modified version of the Medical Outcomes Study SF-36 widely used in VA research and available in the public domain. Internal consistency is high. The VR-36 is scored 0-100 with higher scores representing improved health related quality of life. | 6 Month |
| 38704120 | Derived | Munk N, Daggy JK, Slaven JE, Evans E, Foote T, Laws BV, Matthias MS, Bair MJ. Care ally-assisted massage for Veterans with chronic neck pain: TOMCATT results. Contemp Clin Trials. 2024 Jul;142:107561. doi: 10.1016/j.cct.2024.107561. Epub 2024 May 3. |
| Ally Health |
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| Disinterest |
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| Veteran Health |
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| Moved |
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| Scheduling Conflicts |
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| BG001 | Wait List Control (WL-C) | Participants in the waitlist control will be instructed to continue their medical care as normal and to not begin any massage treatment during the 6 months of the study. At the competition of the final 6 month outcome, participants in the control arm will be eligible to attend a caregiver training session and receive a complementary massage session from a TOMCATT study therapist. |
| BG002 | Care Ally Assisted Massage | CA-M consisted of in-person training for veteran/care-ally dyads to learn a standardized 30-minue massage routine, instructional DVD, and printed treatment manual. Participants were to complete three care ally-assisted massage sessions weekly for 12-weeks. Outcomes collected at baseline, 1-, 3-, and 6- months included validated measures of neck pain severity and associated disability. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Income | Count of Participants | Participants |
|
| PTSD Screener | Count of Participants | Participants |
|
| Comorbidity | Median | Full Range | Number of Comorbid Conditions |
|
Participants randomized to the therapist-treated massage (TT-M) arm will receive a standardized Swedish massage protocol tailored to chronic neck pain. Massage sessions will involve a maximum of 60 minutes of hands-on, table time and occur twice a week (a frequency which balances practicality and efficacy) for 3 months. Therapist treated massage: Participants randomized to the therapist-treated massage (TT-M) arm will receive a standardized Swedish massage protocol tailored to chronic neck pain. Massage sessions will involve a maximum of 60 minutes of hands-on, table time and occur twice a week (a frequency which balances practicality and efficacy) for 3 months. |
| OG001 | Wait List Control (WL-C) | Participants in the waitlist control will be instructed to continue their medical care as normal and to not begin any massage treatment during the 6 months of the study. At the competition of the final 6 month outcome, participants in the control arm will be eligible to attend a caregiver training session and receive a complementary massage session from a TOMCATT study therapist. |
| OG002 | Care Ally Assisted Massage (CA-M) | CA-M consisted of in-person training for veteran/care-ally dyads to learn a standardized 30-minue massage routine, instructional DVD, and printed treatment manual. Participants were to complete three care ally-assisted massage sessions weekly for 12-weeks. Outcomes collected at baseline, 1-, 3-, and 6- months included validated measures of neck pain severity and associated disability. |
|
|
| Primary | Neck Disability Index | The NDI is the standard instrument for measuring self-rated disability due to neck pain. The NDI was developed as a modification of the well-validated Oswestry Low Back Pain Disability Index. The NDI consists of 10-items that assess pain and functioning. All items are framed as a "problem right now" and are scored on a 6-point numeric rating scores of 0 to 5, with 5 being "worst." The total score ranges from 0 to 50, with higher scores representing greater disability from chronic neck pain. The NDI has strong internal consistency (Cronbach's alpha = 0.80) and construct validity. Scoring of the NDI involves: 1) summing the score for each item (raw score); or 2) raw score can be multiplied by 2 to produce a percentage score. The following scoring intervals aid interpretation: 0 - 4 = no disability; 5 - 14 = mild; 15 - 24 = moderate; 25 - 34 = severe; and > 34 = complete disability. At least a 5-point change is defined as "clinically meaningful." | Posted | Mean | Standard Deviation | units on a scale | 1 Month |
|
|
|
| Primary | Neck Disability Index | The NDI is the standard instrument for measuring self-rated disability due to neck pain. The NDI was developed as a modification of the well-validated Oswestry Low Back Pain Disability Index. The NDI consists of 10-items that assess pain and functioning. All items are framed as a "problem right now" and are scored on a 6-point numeric rating scores of 0 to 5, with 5 being "worst." The total score ranges from 0 to 50, with higher scores representing greater disability from chronic neck pain. The NDI has strong internal consistency (Cronbach's alpha = 0.80) and construct validity. Scoring of the NDI involves: 1) summing the score for each item (raw score); or 2) raw score can be multiplied by 2 to produce a percentage score. The following scoring intervals aid interpretation: 0 - 4 = no disability; 5 - 14 = mild; 15 - 24 = moderate; 25 - 34 = severe; and > 34 = complete disability. At least a 5-point change is defined as "clinically meaningful." | Posted | Mean | Standard Deviation | units on a scale | 3 Month |
|
|
|
| Primary | Neck Disability Index | The NDI is the standard instrument for measuring self-rated disability due to neck pain. The NDI was developed as a modification of the well-validated Oswestry Low Back Pain Disability Index. The NDI consists of 10-items that assess pain and functioning. All items are framed as a "problem right now" and are scored on a 6-point numeric rating scores of 0 to 5, with 5 being "worst." The total score ranges from 0 to 50, with higher scores representing greater disability from chronic neck pain. The NDI has strong internal consistency (Cronbach's alpha = 0.80) and construct validity. Scoring of the NDI involves: 1) summing the score for each item (raw score); or 2) raw score can be multiplied by 2 to produce a percentage score. The following scoring intervals aid interpretation: 0 - 4 = no disability; 5 - 14 = mild; 15 - 24 = moderate; 25 - 34 = severe; and > 34 = complete disability. At least a 5-point change is defined as "clinically meaningful." | Posted | Mean | Standard Deviation | units on a scale | 6 Month |
|
|
|
| Secondary | Brief Pain Inventory (BPI) | The Brief Pain Inventory is an 11-item, multidimensional pain measurement tool with reliability in patients with arthritis as well as other pain conditions. The BPI rates the intensity of pain as well as the interference of pain with mood, physical activity, work, social activity, relations, sleep, and enjoyment of life. The BPI has a score range from 0-10 with higher scores representing more severe pain and more pain interference. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
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| Secondary | Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36) | Health-related quality of life will be measured with the VR-36, a modified version of the Medical Outcomes Study SF-36 widely used in VA research and available in the public domain. Internal consistency is high. The VR-36 is scored 0-100 with higher scores representing improved health related quality of life. | Participants refused to answer items from this instrument. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Brief Pain Inventory (BPI) | The Brief Pain Inventory is an 11-item, multidimensional pain measurement tool with reliability in patients with arthritis as well as other pain conditions. The BPI rates the intensity of pain as well as the interference of pain with mood, physical activity, work, social activity, relations, sleep, and enjoyment of life. The BPI has a score range from 0-10 with higher scores representing more severe pain and more pain interference. | Posted | Mean | Standard Deviation | units on a scale | 1 Month |
|
|
|
| Secondary | Brief Pain Inventory (BPI) | The Brief Pain Inventory is an 11-item, multidimensional pain measurement tool with reliability in patients with arthritis as well as other pain conditions. The BPI rates the intensity of pain as well as the interference of pain with mood, physical activity, work, social activity, relations, sleep, and enjoyment of life. The BPI has a score range from 0-10 with higher scores representing more severe pain and more pain interference. | Posted | Mean | Standard Deviation | units on a scale | 3 Month |
|
|
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| Secondary | Brief Pain Inventory (BPI) | The Brief Pain Inventory is an 11-item, multidimensional pain measurement tool with reliability in patients with arthritis as well as other pain conditions. The BPI rates the intensity of pain as well as the interference of pain with mood, physical activity, work, social activity, relations, sleep, and enjoyment of life. The BPI has a score range from 0-10 with higher scores representing more severe pain and more pain interference. | Posted | Mean | Standard Deviation | units on a scale | 6 Month |
|
|
|
| Secondary | Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36) | Health-related quality of life will be measured with the VR-36, a modified version of the Medical Outcomes Study SF-36 widely used in VA research and available in the public domain. Internal consistency is high. The VR-36 is scored 0-100 with higher scores representing improved health related quality of life. | Participants refused to answer items from this instrument. | Posted | Mean | Standard Deviation | units on a scale | 1 Month |
|
|
|
| Secondary | Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36) | Health-related quality of life will be measured with the VR-36, a modified version of the Medical Outcomes Study SF-36 widely used in VA research and available in the public domain. Internal consistency is high. The VR-36 is scored 0-100 with higher scores representing improved health related quality of life. | Participants refused to answer items from this instrument. | Posted | Mean | Standard Deviation | units on a scale | 3 Month |
|
|
|
| Secondary | Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36) | Health-related quality of life will be measured with the VR-36, a modified version of the Medical Outcomes Study SF-36 widely used in VA research and available in the public domain. Internal consistency is high. The VR-36 is scored 0-100 with higher scores representing improved health related quality of life. | Participants refused to answer items from this instrument. | Posted | Mean | Standard Deviation | units on a scale | 6 Month |
|
|
|
| 1 |
| 145 |
| 10 |
| 145 |
| 106 |
| 145 |
| EG001 | Wait List Control (WL-C) | Participants in the waitlist control will be instructed to continue their medical care as normal and to not begin any massage treatment during the 6 months of the study. At the competition of the final 6 month outcome, participants in the control arm will be eligible to attend a caregiver training session and receive a complementary massage session from a TOMCATT study therapist. | 0 | 145 | 3 | 145 | 13 | 145 |
| EG002 | Care Ally Assisted Massage | CA-M consisted of in-person training for veteran/care-ally dyads to learn a standardized 30-minue massage routine, instructional DVD, and printed treatment manual. Participants were to complete three care ally-assisted massage sessions weekly for 12-weeks. Outcomes collected at baseline, 1-, 3-, and 6- months included validated measures of neck pain severity and associated disability. | 1 | 102 | 6 | 102 | 14 | 102 |
| PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| INPATIENT ADMISSION | Nervous system disorders | Non-systematic Assessment |
|
| SURGERY | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| PAIN | Nervous system disorders | Non-systematic Assessment |
|
| SWELLING | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| SURGERY | Surgical and medical procedures | Non-systematic Assessment |
|
| INPATIENT ADMISSION | Infections and infestations | Non-systematic Assessment |
|
| INPATIENT ADMISSION | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| PAIN | Cardiac disorders | Non-systematic Assessment |
|
| HEADACHE | Nervous system disorders | Non-systematic Assessment |
|
| INFECTION | Infections and infestations | Non-systematic Assessment |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| SORENESS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| STIFFNESS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| SURGERY | Surgical and medical procedures | Non-systematic Assessment |
|
| DISCOMFORT | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| SHOULDER DISLOCATION | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| DIZZINESS | General disorders | Non-systematic Assessment |
|
| HEART PAIN | Cardiac disorders | Non-systematic Assessment |
|
| LEG PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| NUMBNESS | Nervous system disorders | Non-systematic Assessment |
|
| PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| SHOULDER PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| SKIN REACTION | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| STOMACH ISSUES | Gastrointestinal disorders | Non-systematic Assessment |
|
| TENDERNESS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| SHOULDER PAIN | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| FATIGUE | General disorders | Non-systematic Assessment |
|
| HYPERVENTILATING | Psychiatric disorders | Non-systematic Assessment |
|
| KIDNEY LUMPS | Renal and urinary disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D009140 | Musculoskeletal Diseases |
| D009135 | Muscular Diseases |
| D012216 | Rheumatic Diseases |