Trial Outcomes & Findings for An Interactive Gaming-based Intervention for Back Pain (NCT NCT02503410)

Last Updated: 2019-05-28

Results Overview

Subjects are asked to indicate their pain level using a visual analog scale, namely they are asked to choose the position on a horizontal line - drawn on a piece of paper - that corresponds to the pain level that they experience. The line is about 10 cm long and is divided into 10 intervals of equal length referred to as units. The minimum value on the scale is zero (meaning no pain). The maximum value on the scale is ten (meaning maximum ever experienced pain).

Recruitment status

TERMINATED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

Change from baseline in Visual Analogue Pain Scale score at 4 weeks

Results posted on

2019-05-28

Participant Flow

Subjects were recruited primarily among the outpatient population of individuals with low back pain at Spaulding Rehabilitation Hospital.

Participant milestones

Participant milestones
Measure	Usual Care Subjects receive physical therapy for low back pain as typically prescribed in the clinic.	Interactive Gaming Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system.
Overall Study STARTED	4	3
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Interactive Gaming-based Intervention for Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=4 Participants Subjects receive physical therapy for low back pain as typically prescribed in the clinic.	Interactive Gaming n=3 Participants Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system.	Total n=7 Participants Total of all reporting groups
Age, Continuous	36.8 years STANDARD_DEVIATION 10.4 • n=5 Participants	31.7 years STANDARD_DEVIATION 3.8 • n=7 Participants	34.6 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Visual Analog Pain Scale	3.5 units on a scale STANDARD_DEVIATION 1.3 • n=5 Participants	4.0 units on a scale STANDARD_DEVIATION 1.0 • n=7 Participants	3.7 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants
Pain Frequency	5.3 days STANDARD_DEVIATION 0.9 • n=5 Participants	6.0 days STANDARD_DEVIATION 1.7 • n=7 Participants	5.8 days STANDARD_DEVIATION 1.2 • n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline in Visual Analogue Pain Scale score at 4 weeks

Outcome measures

Outcome measures
Measure	Usual Care Group n=4 Participants physical therapy (as prescribed during 8 to 12 weeks) and home exercises (at least 2x/week) Home-based exercises: Subjects will receive a combination of physical therapy and home exercise program during 8 to 12 weeks. Home exercise will be recommended at least two times a week. Usual Care of LBP provided in SRH consists of exercises and manual therapy in various combinations according to the needs of the subject. Subjects will fill out a questionnaire about their pain and how much time they spent doing the home exercises every two weeks.	Interactive Home-Based System Group n=3 Participants physical therapy (as prescribed during 8 to 12 weeks) and interactive exercises program at home with the Valedo® System (Hocoma AG) (at least 2x/week) Interactive gaming home-based exercises: Subjects will receive a combination of physical therapy (during 8 to 12 weeks) and at least two sessions of interactive exercises program at home with the Valedo® System (Hocoma AG). Subjects will fill out a questionnaire about their pain every two weeks during the treatment period. Valedo® System (Hocoma AG)
Visual Analogue Pain Scale at 4 Weeks	0.0 units on a scale Standard Deviation 0.8	0.3 units on a scale Standard Deviation 1.2

PRIMARY outcome

Timeframe: Change from baseline in VAS score at 8 weeks

Outcome measures

Outcome measures
Measure	Usual Care Group n=4 Participants physical therapy (as prescribed during 8 to 12 weeks) and home exercises (at least 2x/week) Home-based exercises: Subjects will receive a combination of physical therapy and home exercise program during 8 to 12 weeks. Home exercise will be recommended at least two times a week. Usual Care of LBP provided in SRH consists of exercises and manual therapy in various combinations according to the needs of the subject. Subjects will fill out a questionnaire about their pain and how much time they spent doing the home exercises every two weeks.	Interactive Home-Based System Group n=3 Participants physical therapy (as prescribed during 8 to 12 weeks) and interactive exercises program at home with the Valedo® System (Hocoma AG) (at least 2x/week) Interactive gaming home-based exercises: Subjects will receive a combination of physical therapy (during 8 to 12 weeks) and at least two sessions of interactive exercises program at home with the Valedo® System (Hocoma AG). Subjects will fill out a questionnaire about their pain every two weeks during the treatment period. Valedo® System (Hocoma AG)
Visual Analogue Pain Scale at 8 Weeks	0.2 units on a scale Standard Deviation 1.7	1.3 units on a scale Standard Deviation 1.2

PRIMARY outcome

Timeframe: Change in pain frequency at 4 weeks

Subjects are asked how many days they experienced low back pain during the week prior to the study visit.

Outcome measures

Outcome measures
Measure	Usual Care Group n=4 Participants physical therapy (as prescribed during 8 to 12 weeks) and home exercises (at least 2x/week) Home-based exercises: Subjects will receive a combination of physical therapy and home exercise program during 8 to 12 weeks. Home exercise will be recommended at least two times a week. Usual Care of LBP provided in SRH consists of exercises and manual therapy in various combinations according to the needs of the subject. Subjects will fill out a questionnaire about their pain and how much time they spent doing the home exercises every two weeks.	Interactive Home-Based System Group n=3 Participants physical therapy (as prescribed during 8 to 12 weeks) and interactive exercises program at home with the Valedo® System (Hocoma AG) (at least 2x/week) Interactive gaming home-based exercises: Subjects will receive a combination of physical therapy (during 8 to 12 weeks) and at least two sessions of interactive exercises program at home with the Valedo® System (Hocoma AG). Subjects will fill out a questionnaire about their pain every two weeks during the treatment period. Valedo® System (Hocoma AG)
Pain Frequency at 4 Weeks	2.5 days Standard Deviation 2.4	-0.3 days Standard Deviation 0.6

PRIMARY outcome

Timeframe: Change in pain frequency at 8 weeks

Subjects are asked how many days they experienced low back pain during the week prior to the study visit.

Outcome measures

Outcome measures
Measure	Usual Care Group n=4 Participants physical therapy (as prescribed during 8 to 12 weeks) and home exercises (at least 2x/week) Home-based exercises: Subjects will receive a combination of physical therapy and home exercise program during 8 to 12 weeks. Home exercise will be recommended at least two times a week. Usual Care of LBP provided in SRH consists of exercises and manual therapy in various combinations according to the needs of the subject. Subjects will fill out a questionnaire about their pain and how much time they spent doing the home exercises every two weeks.	Interactive Home-Based System Group n=3 Participants physical therapy (as prescribed during 8 to 12 weeks) and interactive exercises program at home with the Valedo® System (Hocoma AG) (at least 2x/week) Interactive gaming home-based exercises: Subjects will receive a combination of physical therapy (during 8 to 12 weeks) and at least two sessions of interactive exercises program at home with the Valedo® System (Hocoma AG). Subjects will fill out a questionnaire about their pain every two weeks during the treatment period. Valedo® System (Hocoma AG)
Pain Frequency at 8 Weeks	-0.2 days Standard Deviation 2.1	0.0 days Standard Deviation 0.0

SECONDARY outcome

Timeframe: Change in disability score at 4 weeks

Subjects are asked to fill in a questionnaire inquiring about how their pain interferes with their activities of daily living. Accordingly, they receive a disability score ranging between 0 and 100%. A score between 0 and 20% indicates minimal disability; a score between 21 and 40% indicates moderate disability; a score between 41 and 60% indicates severe disability; a score between 61 and 80% indicates that pain impinges on all aspects of the patient's life; and score between 81 and 100% indicates that the subject is bed-bound.

Outcome measures

Outcome measures
Measure	Usual Care Group n=4 Participants physical therapy (as prescribed during 8 to 12 weeks) and home exercises (at least 2x/week) Home-based exercises: Subjects will receive a combination of physical therapy and home exercise program during 8 to 12 weeks. Home exercise will be recommended at least two times a week. Usual Care of LBP provided in SRH consists of exercises and manual therapy in various combinations according to the needs of the subject. Subjects will fill out a questionnaire about their pain and how much time they spent doing the home exercises every two weeks.	Interactive Home-Based System Group n=3 Participants physical therapy (as prescribed during 8 to 12 weeks) and interactive exercises program at home with the Valedo® System (Hocoma AG) (at least 2x/week) Interactive gaming home-based exercises: Subjects will receive a combination of physical therapy (during 8 to 12 weeks) and at least two sessions of interactive exercises program at home with the Valedo® System (Hocoma AG). Subjects will fill out a questionnaire about their pain every two weeks during the treatment period. Valedo® System (Hocoma AG)
Oswestry Low Back Pain Disability Questionnaire at 4 Weeks	1.0 percentage disability Standard Deviation 3.5	4.7 percentage disability Standard Deviation 4.6

SECONDARY outcome

Timeframe: Change in disability score at 8 weeks

Outcome measures

Outcome measures
Measure	Usual Care Group n=4 Participants physical therapy (as prescribed during 8 to 12 weeks) and home exercises (at least 2x/week) Home-based exercises: Subjects will receive a combination of physical therapy and home exercise program during 8 to 12 weeks. Home exercise will be recommended at least two times a week. Usual Care of LBP provided in SRH consists of exercises and manual therapy in various combinations according to the needs of the subject. Subjects will fill out a questionnaire about their pain and how much time they spent doing the home exercises every two weeks.	Interactive Home-Based System Group n=3 Participants physical therapy (as prescribed during 8 to 12 weeks) and interactive exercises program at home with the Valedo® System (Hocoma AG) (at least 2x/week) Interactive gaming home-based exercises: Subjects will receive a combination of physical therapy (during 8 to 12 weeks) and at least two sessions of interactive exercises program at home with the Valedo® System (Hocoma AG). Subjects will fill out a questionnaire about their pain every two weeks during the treatment period. Valedo® System (Hocoma AG)
Oswestry Low Back Pain Disability Questionnaire at 8 Weeks	12.7 percentage disability Standard Deviation 10.6	11.3 percentage disability Standard Deviation 7.0

SECONDARY outcome

Timeframe: Change in clinical score at 4 weeks

The SF36 is a clinical outcome measure based on the administration of a questionnaire inquiring about the quality of life and health status of the subject. It consists of eight normalized (so that they have the some weight) scores related to vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The lower the score the more disability. The higher the score the less disability. The score is provide as units on a scale from 0 to 100.

Outcome measures

Outcome measures
Measure	Usual Care Group n=4 Participants physical therapy (as prescribed during 8 to 12 weeks) and home exercises (at least 2x/week) Home-based exercises: Subjects will receive a combination of physical therapy and home exercise program during 8 to 12 weeks. Home exercise will be recommended at least two times a week. Usual Care of LBP provided in SRH consists of exercises and manual therapy in various combinations according to the needs of the subject. Subjects will fill out a questionnaire about their pain and how much time they spent doing the home exercises every two weeks.	Interactive Home-Based System Group n=3 Participants physical therapy (as prescribed during 8 to 12 weeks) and interactive exercises program at home with the Valedo® System (Hocoma AG) (at least 2x/week) Interactive gaming home-based exercises: Subjects will receive a combination of physical therapy (during 8 to 12 weeks) and at least two sessions of interactive exercises program at home with the Valedo® System (Hocoma AG). Subjects will fill out a questionnaire about their pain every two weeks during the treatment period. Valedo® System (Hocoma AG)
SF36 at 4 Weeks	2.6 units on a scale Standard Deviation 14.6	6.6 units on a scale Standard Deviation 11.2

SECONDARY outcome

Timeframe: Change in clinical score at 8 weeks

Outcome measures

Outcome measures
Measure	Usual Care Group n=4 Participants physical therapy (as prescribed during 8 to 12 weeks) and home exercises (at least 2x/week) Home-based exercises: Subjects will receive a combination of physical therapy and home exercise program during 8 to 12 weeks. Home exercise will be recommended at least two times a week. Usual Care of LBP provided in SRH consists of exercises and manual therapy in various combinations according to the needs of the subject. Subjects will fill out a questionnaire about their pain and how much time they spent doing the home exercises every two weeks.	Interactive Home-Based System Group n=3 Participants physical therapy (as prescribed during 8 to 12 weeks) and interactive exercises program at home with the Valedo® System (Hocoma AG) (at least 2x/week) Interactive gaming home-based exercises: Subjects will receive a combination of physical therapy (during 8 to 12 weeks) and at least two sessions of interactive exercises program at home with the Valedo® System (Hocoma AG). Subjects will fill out a questionnaire about their pain every two weeks during the treatment period. Valedo® System (Hocoma AG)
SF36 at 8 Weeks	13.2 units on a scale Standard Deviation 6.1	9.5 units on a scale Standard Deviation 15.7

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Interactive Gaming

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paolo Bonato

Spaulding Rehabilitation Hospital

Phone: 617-952-6319

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place