Trial Outcomes & Findings for Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated (NCT NCT03100539)

Last Updated: 2024-09-20

Results Overview

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."

Recruitment status

COMPLETED

Study phase

Target enrollment

395 participants

Primary outcome timeframe

Baseline

Results posted on

2024-09-20

Participant Flow

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 Three participants were withdrawn post-randomization: one consent revoked and two COVID re-randomizations.

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	145	145	102
Overall Study 1 Month	109	114	43
Overall Study 3 Month	87	109	34
Overall Study 6 Month	77	83	39
Overall Study COMPLETED	77	83	39
Overall Study NOT COMPLETED	68	62	63

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Overall Study Lost to Follow-up	60	54	17
Overall Study Uncollected	8	8	0
Overall Study Ally Health	0	0	3
Overall Study Disinterest	0	0	22
Overall Study Veteran Health	0	0	8
Overall Study Moved	0	0	1
Overall Study Scheduling Conflicts	0	0	12

Baseline Characteristics

Trial Outcomes for Massage: Caregiver-Assisted vs. Therapist-Treated

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Therapist Treated Massage (TT-M) n=145 Participants 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.	Wait List Control (WL-C) n=145 Participants 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 n=102 Participants 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.	Total n=392 Participants Total of all reporting groups
Age, Continuous	55.6 Years STANDARD_DEVIATION 13.7 • n=5 Participants	56.0 Years STANDARD_DEVIATION 13.7 • n=7 Participants	57.2 Years STANDARD_DEVIATION 14.3 • n=5 Participants	55.8 Years STANDARD_DEVIATION 13.7 • n=4 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	22 Participants n=7 Participants	15 Participants n=5 Participants	57 Participants n=4 Participants
Sex: Female, Male Male	125 Participants n=5 Participants	123 Participants n=7 Participants	87 Participants n=5 Participants	335 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	137 Participants n=5 Participants	141 Participants n=7 Participants	101 Participants n=5 Participants	379 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	33 Participants n=5 Participants	33 Participants n=7 Participants	19 Participants n=5 Participants	85 Participants n=4 Participants
Race (NIH/OMB) White	94 Participants n=5 Participants	103 Participants n=7 Participants	77 Participants n=5 Participants	274 Participants n=4 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	19 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	14 Participants n=4 Participants
Education High School Education or Less	28 Participants n=5 Participants	27 Participants n=7 Participants	22 Participants n=5 Participants	77 Participants n=4 Participants
Education Tech/Business/Associates	57 Participants n=5 Participants	66 Participants n=7 Participants	45 Participants n=5 Participants	168 Participants n=4 Participants
Education Bachelors or Greater	49 Participants n=5 Participants	48 Participants n=7 Participants	32 Participants n=5 Participants	129 Participants n=4 Participants
Education Unknown or Not Reported	11 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	18 Participants n=4 Participants
Marital Status Married or Partnered	84 Participants n=5 Participants	88 Participants n=7 Participants	77 Participants n=5 Participants	249 Participants n=4 Participants
Marital Status Non-Partnered	51 Participants n=5 Participants	52 Participants n=7 Participants	23 Participants n=5 Participants	126 Participants n=4 Participants
Marital Status Unknown or Not Reported	10 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	17 Participants n=4 Participants
Employment Employed	69 Participants n=5 Participants	59 Participants n=7 Participants	44 Participants n=5 Participants	172 Participants n=4 Participants
Employment Retired	42 Participants n=5 Participants	50 Participants n=7 Participants	38 Participants n=5 Participants	130 Participants n=4 Participants
Employment Unable to Work	14 Participants n=5 Participants	18 Participants n=7 Participants	8 Participants n=5 Participants	40 Participants n=4 Participants
Employment Other	11 Participants n=5 Participants	13 Participants n=7 Participants	9 Participants n=5 Participants	33 Participants n=4 Participants
Employment Unknown or Not Reported	9 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	17 Participants n=4 Participants
Income Comfortable	77 Participants n=5 Participants	70 Participants n=7 Participants	57 Participants n=5 Participants	204 Participants n=4 Participants
Income Just Enough	48 Participants n=5 Participants	53 Participants n=7 Participants	34 Participants n=5 Participants	135 Participants n=4 Participants
Income Not Enough	11 Participants n=5 Participants	14 Participants n=7 Participants	5 Participants n=5 Participants	30 Participants n=4 Participants
Income Don't Know/Refuse to Answer	1 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Income Unknown or Not Reported	8 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	14 Participants n=4 Participants
PTSD Screener PTSD Screen Positive	58 Participants n=5 Participants	54 Participants n=7 Participants	36 Participants n=5 Participants	148 Participants n=4 Participants
PTSD Screener PTSD Screen Negative	87 Participants n=5 Participants	91 Participants n=7 Participants	66 Participants n=5 Participants	244 Participants n=4 Participants
Comorbidity	3 Number of Comorbid Conditions n=5 Participants	3 Number of Comorbid Conditions n=7 Participants	0 Number of Comorbid Conditions n=5 Participants	3 Number of Comorbid Conditions n=4 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Therapist Treated Massage (TT-M) n=145 Participants 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.	Wait List Control (WL-C) n=145 Participants 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) n=102 Participants 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.
Neck Disability Index	20.3 units on a scale Standard Deviation 7.7	20.5 units on a scale Standard Deviation 8.5	18.3 units on a scale Standard Deviation 7.9

PRIMARY outcome

Timeframe: 1 Month

Outcome measures

Outcome measures
Measure	Therapist Treated Massage (TT-M) n=109 Participants 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.	Wait List Control (WL-C) n=114 Participants 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) n=43 Participants 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.
Neck Disability Index	18.7 units on a scale Standard Deviation 8.4	21.1 units on a scale Standard Deviation 9.2	18.1 units on a scale Standard Deviation 8.5

PRIMARY outcome

Timeframe: 3 Month

Outcome measures

Outcome measures
Measure	Therapist Treated Massage (TT-M) n=87 Participants 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.	Wait List Control (WL-C) n=109 Participants 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) n=34 Participants 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.
Neck Disability Index	17.0 units on a scale Standard Deviation 18.6	21.2 units on a scale Standard Deviation 9.0	15.1 units on a scale Standard Deviation 8.7

PRIMARY outcome

Timeframe: 6 Month

Outcome measures

Outcome measures
Measure	Therapist Treated Massage (TT-M) n=77 Participants 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.	Wait List Control (WL-C) n=83 Participants 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) n=39 Participants 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.
Neck Disability Index	18.5 units on a scale Standard Deviation 8.3	21.6 units on a scale Standard Deviation 9.8	14.9 units on a scale Standard Deviation 8.3

SECONDARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Therapist Treated Massage (TT-M) n=145 Participants 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.	Wait List Control (WL-C) n=145 Participants 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) n=102 Participants 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.
Brief Pain Inventory (BPI)	6.1 units on a scale Standard Deviation 1.7	6.2 units on a scale Standard Deviation 1.8	6.0 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Baseline

Population: Participants refused to answer items from this instrument.

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.

Outcome measures

Outcome measures
Measure	Therapist Treated Massage (TT-M) n=144 Participants 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.	Wait List Control (WL-C) n=142 Participants 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) n=95 Participants 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.
Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36)	45.7 units on a scale Standard Deviation 13.3	46.2 units on a scale Standard Deviation 14.2	47.0 units on a scale Standard Deviation 12.3

SECONDARY outcome

Timeframe: 1 Month

Outcome measures

Outcome measures
Measure	Therapist Treated Massage (TT-M) n=109 Participants 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.	Wait List Control (WL-C) n=114 Participants 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) n=42 Participants 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.
Brief Pain Inventory (BPI)	5.1 units on a scale Standard Deviation 1.9	6.0 units on a scale Standard Deviation 2.0	5.5 units on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: 3 Month

Outcome measures

Outcome measures
Measure	Therapist Treated Massage (TT-M) n=87 Participants 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.	Wait List Control (WL-C) n=109 Participants 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) n=34 Participants 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.
Brief Pain Inventory (BPI)	4.5 units on a scale Standard Deviation 2.0	6.0 units on a scale Standard Deviation 1.9	4.6 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 6 Month

Outcome measures

Outcome measures
Measure	Therapist Treated Massage (TT-M) n=77 Participants 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.	Wait List Control (WL-C) n=83 Participants 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) n=37 Participants 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.
Brief Pain Inventory (BPI)	4.7 units on a scale Standard Deviation 2.2	5.7 units on a scale Standard Deviation 1.9	4.5 units on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: 1 Month

Population: Participants refused to answer items from this instrument.

Outcome measures

Outcome measures
Measure	Therapist Treated Massage (TT-M) n=107 Participants 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.	Wait List Control (WL-C) n=108 Participants 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) n=42 Participants 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.
Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36)	47.4 units on a scale Standard Deviation 13.4	46.7 units on a scale Standard Deviation 14.2	47.7 units on a scale Standard Deviation 13.2

SECONDARY outcome

Timeframe: 3 Month

Population: Participants refused to answer items from this instrument.

Outcome measures

Outcome measures
Measure	Therapist Treated Massage (TT-M) n=87 Participants 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.	Wait List Control (WL-C) n=105 Participants 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) n=34 Participants 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.
Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36)	47.9 units on a scale Standard Deviation 12.0	45.7 units on a scale Standard Deviation 14.4	51.3 units on a scale Standard Deviation 15.0

SECONDARY outcome

Timeframe: 6 Month

Population: Participants refused to answer items from this instrument.

Outcome measures

Outcome measures
Measure	Therapist Treated Massage (TT-M) n=77 Participants 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.	Wait List Control (WL-C) n=83 Participants 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) n=38 Participants 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.
Medical Outcomes Study Veterans RAND 36 Item Health Survey (VR-36) (Modified From Medical Outcomes Study SF-36)	45.8 units on a scale Standard Deviation 12.8	43.4 units on a scale Standard Deviation 15.8	49.7 units on a scale Standard Deviation 11.8

Adverse Events

Therapist Treated Massage (TT-M)

Serious events: 10 serious events

Other events: 106 other events

Deaths: 1 deaths

Wait List Control (WL-C)

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Care Ally Assisted Massage

Serious events: 6 serious events

Other events: 14 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Therapist Treated Massage (TT-M) n=145 participants at risk 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.	Wait List Control (WL-C) n=145 participants at risk 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 n=102 participants at risk 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.
Nervous system disorders DEATH	0.69% 1/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.98% 1/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Musculoskeletal and connective tissue disorders PAIN	2.1% 3/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.98% 1/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Nervous system disorders INPATIENT ADMISSION	0.69% 1/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.69% 1/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Musculoskeletal and connective tissue disorders SURGERY	0.69% 1/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	2.0% 2/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Nervous system disorders PAIN	0.69% 1/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Musculoskeletal and connective tissue disorders SWELLING	0.69% 1/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Surgical and medical procedures SURGERY	1.4% 2/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Infections and infestations INPATIENT ADMISSION	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.69% 1/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Respiratory, thoracic and mediastinal disorders INPATIENT ADMISSION	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.69% 1/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.98% 1/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Cardiac disorders PAIN	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.98% 1/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.

Other adverse events

Additional Information

Dr. Matthew Bair, Director of Center for Health Information and Communication

Richard L Roudebush VA Medical Center

Phone: 317-988-2058

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Therapist Treated Massage (TT-M) n=145 participants at risk 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.	Wait List Control (WL-C) n=145 participants at risk 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 n=102 participants at risk 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.
Musculoskeletal and connective tissue disorders BACK PAIN	4.8% 7/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.69% 1/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.98% 1/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Nervous system disorders HEADACHE	2.1% 3/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.69% 1/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Infections and infestations INFECTION	2.8% 4/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	1.4% 2/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	2.9% 3/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Musculoskeletal and connective tissue disorders NECK PAIN	8.3% 12/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	3.4% 5/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Musculoskeletal and connective tissue disorders SORENESS	21.4% 31/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.69% 1/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.98% 1/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Musculoskeletal and connective tissue disorders STIFFNESS	12.4% 18/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	1.4% 2/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Surgical and medical procedures SURGERY	2.1% 3/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.69% 1/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	2.0% 2/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Musculoskeletal and connective tissue disorders DISCOMFORT	2.1% 3/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Injury, poisoning and procedural complications SHOULDER DISLOCATION	0.69% 1/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
General disorders DIZZINESS	2.1% 3/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.98% 1/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Cardiac disorders HEART PAIN	0.69% 1/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Musculoskeletal and connective tissue disorders LEG PAIN	1.4% 2/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Nervous system disorders NUMBNESS	0.69% 1/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Musculoskeletal and connective tissue disorders PAIN	8.3% 12/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	2.0% 2/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Musculoskeletal and connective tissue disorders SHOULDER PAIN	1.4% 2/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Skin and subcutaneous tissue disorders SKIN REACTION	0.69% 1/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Gastrointestinal disorders STOMACH ISSUES	0.69% 1/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Musculoskeletal and connective tissue disorders TENDERNESS	0.69% 1/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Injury, poisoning and procedural complications SHOULDER PAIN	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.98% 1/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
General disorders FATIGUE	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.98% 1/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Psychiatric disorders HYPERVENTILATING	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.98% 1/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.
Renal and urinary disorders KIDNEY LUMPS	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.00% 0/145 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.	0.98% 1/102 • SAEs, AEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 6 months.