Neck PainTOMCATTNCT03100539
Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated
A study testing Therapist treated massage and Care ally assisted massage in people with Neck Pain and Chronic Pain, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain, Chronic Pain, Pain
- What is being tested?
- Therapist treated massage and Care ally assisted massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic neck pain for 6 months or longer
- Neck pain of at least moderate severity (NDI score greater than or equal to 10)
Who cannot join
- Neck pain secondary to vertebral fracture or metastatic cancer
- Complex neck pain (e.g. cervical radiculopathy or recent whiplash injury)
- Any massage professional massage therapy within the last 6 months
- Active suicidal ideation
- Moderate to severe cognitive impairment
- Pending neck surgery
- Involvement in active pain or massage trials
Trial locations and contacts
1 site in 1 country.
United States1 site
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2803
About this study
Official title: Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated (TOMCATT)
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.
Read the detailed description
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.
- Conditions
- Neck Pain, Chronic Pain, Pain, Arthritis, Musculoskeletal Pain, Osteoarthritis
- Being tested
- Therapist treated massage, Care ally assisted massage
- Keywords
- Massage, Fascia
- Medical subject headings
- Neck Pain, Chronic Pain, Pain, Arthritis, Musculoskeletal Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist treated massageOther
Also called 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.
Care ally assisted massageOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Therapist treated massage |
| 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. Receives: Other: Care ally assisted massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 6 Month
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 May 2017
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Matthew J. Bair, MD MS, Principal investigator, Richard L. Roudebush VA Medical Center, Indianapolis, IN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100539
- Sponsor's protocol ID
- IIR 15-333
- Acronym
- TOMCATT
- Status last verified
- Aug 2024
- First submitted
- 6 Mar 2017
- Last updated
- 20 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36166287Munk 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.
PubMed 40875586Munk 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.
PubMed 38704120
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated (TOMCATT)
- ClinicalTrials.gov ID
- NCT03100539
- Acronym / sponsor ID
- TOMCATT / IIR 15-333
- Conditions
- Neck Pain, Chronic Pain, Pain, Arthritis, Musculoskeletal Pain, Osteoarthritis
- Keywords
- Massage, Fascia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 May 2017 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Posted 20 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Therapist treated massage (TT-M) | Experimental | Other: Therapist treated massageParticipants 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 | Other: Care ally assisted massageCA-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic neck pain for 6 months or longer
- Neck pain of at least moderate severity (NDI score greater than or equal to 10)
Key exclusion criteria (7 listed)
- Neck pain secondary to vertebral fracture or metastatic cancer
- Complex neck pain (e.g. cervical radiculopathy or recent whiplash injury)
- Any massage professional massage therapy within the last 6 months
- Active suicidal ideation
- Moderate to severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapist treated massageAlso: TT-MParticipants 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. | Other | Therapist treated massage (TT-M) |
| Care ally assisted massageAlso: CA-MCA-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. | Other | Care ally assisted massage (CA-M) |
Primary outcome
Neck Disability Index
Time frame: Baseline
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."
Neck Disability Index
Time frame: 1 Month
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."
Neck Disability Index
Time frame: 3 Month
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."
Neck Disability Index
Time frame: 6 Month
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."
8 secondary outcomes
Brief Pain Inventory (BPI)
Time frame: Baseline
Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36)
Time frame: Baseline
Brief Pain Inventory (BPI)
Time frame: 1 Month
Brief Pain Inventory (BPI)
Time frame: 3 Month
Brief Pain Inventory (BPI)
Time frame: 6 Month
Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36)
Time frame: 1 Month
Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36)
Time frame: 3 Month
Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36)
Time frame: 6 Month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36166287Munk 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.
- Derived from this study: PubMed 40875586Munk 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.
- Derived from this study: PubMed 38704120Munk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J. Bair, MD MS principal investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapist treated massage and Care ally assisted massage in people with Neck Pain and Chronic Pain, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03100539, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.