Osteoarthritis, Pain
Conditions
Keywords
Osteoarthritis, Activity Pacing
Brief summary
The primary objective of this project is to examine effectiveness of a tailored pacing intervention on fatigue, pain, and physical function compared to general pacing intervention and usual care groups. A secondary objective is to evaluate the natural history of symptoms and physical disability over time among people with knee and hip osteoarthritis.
Detailed description
In the United States, osteoarthritis is a growing public health issue and a leading cause of disability among older adults. Almost 50% of users of the Veterans Affairs (VA) system present with osteoarthritis. Veterans are a particularly important group to target for symptom management interventions as they are twice as likely as non-veterans to report chronic joint symptoms and activity limitations. There are few evidence-based symptom management interventions offered by health care professionals, such as occupational and physical therapists, at the time when people are seeking treatment for their symptoms. The proposed activity pacing intervention is individually-tailored to a person's symptom and activity patterns. This tailoring provides a personally-relevant and focused intervention that may help people adopt this strategy into their daily lives.
Interventions
BEHAVIORALTailored Activity Pacing
Therapeutic intervention will be based on a tailored approach using collected data on symptom and activity patterns of each participant.
BEHAVIORALGeneral Activity Pacing
Therapeutic intervention using generalized pacing instruction to manage symptoms
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age of 50 years and older * Reported pain for at least 3 months * Mild-moderate pain severity according to the WOMAC pain scale * Radiographic evidence of knee or hip osteoarthritis (Kellgren-Lawrence score of 2 in at least one joint) * Community-dwelling (i.e. own home, apartment, senior residence) * Ambulatory with or without a cane or walker * Adequate cognition to complete study activities (score of 5 on the 6-Item Screener) * Ability to use the Actiwatch-S (Phillips-Respironics, Mini-Mitter, Bend OR)accelerometer to record symptoms and activity patterns (ascertained by completion of a learning module specific to the use of the device in this study) * English-speaking
Exclusion criteria
* Self-reported medical history of conditions with pain and/or fatigue as a known and marked symptom (e.g multiple sclerosis, rheumatoid arthritis) * Medically unstable (e.g. acute conditions or acute presentations of chronic conditions) * Anemia (hemoglobin of \<10 for men and \<11 for women) * Unmanaged thyroid dysfunction (Thyroid stimulating hormone \<.035\>5.5 mg/dl) * 2 or more days of complete bed rest within the last month * Limb hemiplegia or amputation * Arthroscopic procedure within the previous 2 months * Joint injection within the previous 3 months * Total or partial joint replacement within the previous 6 months * Self-reported illness or conditions that impair cooperation with the study team or ability to complete study procedures * Current enrollee in physical or occupational therapy for symptoms associated with osteoarthritis * Current attendance or attendance within the previous year in a cognitive behavioral therapy program or other self-management program that includes activity pacing instruction * Any other unforeseen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue- Brief Fatigue Inventory (BFI) | Baseline | This is a summary measure of fatigue severity and fatigue interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue. |
| Fatigue-BFI | 10 weeks post-baseline | This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue. |
| Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Baseline | This is a summary of reported pain in specific activities. It is 5 questions with answers ranging from 0 - 4. Total possible score is 20 in which a higher score is worse pain. |
| Pain- WOMAC | 10 weeks post-baseline | This is a 5-item pain scale in which scores from 0 - 4 are summed. A higher score indicates more pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Function- Six Minute Walk | Baseline | Six minute walk is the distance (in feet) that people walk at a usual pace over 6 minutes |
Countries
United States
Participant flow
Recruitment details
Potential participants were recruited through fliers and advertisements.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Tailored activity pacing
Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant. | 66 |
| Arm 2 General activity pacing and symptom management
General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms | 66 |
| Arm 3 Usual care group | 63 |
| Total | 195 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 10 | 7 |
| Overall Study | started new treatment | 5 | 1 | 0 |
| Overall Study | Unable to follow Actiwatch instructions | 4 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 4 | 1 |
Baseline characteristics
| Characteristic | Arm 2 | Arm 3 | Arm 1 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 30 Participants | 27 Participants | 27 Participants | 84 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 36 Participants | 39 Participants | 111 Participants |
| Age, Continuous | 64.1 years STANDARD_DEVIATION 8.3 | 65.8 years STANDARD_DEVIATION 8.7 | 64.5 years STANDARD_DEVIATION 8.1 | 64.8 years STANDARD_DEVIATION 8.4 |
| Region of Enrollment United States | 66 participants | 63 participants | 66 participants | 195 participants |
| Sex: Female, Male Female | 41 Participants | 39 Participants | 40 Participants | 120 Participants |
| Sex: Female, Male Male | 25 Participants | 24 Participants | 26 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 66 | 3 / 66 | 1 / 63 |
| serious Total, serious adverse events | 0 / 66 | 0 / 66 | 0 / 63 |
Outcome results
Primary
Fatigue-BFI
This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.
Time frame: 10 weeks post-baseline
Population: Sample numbers may differ due to missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Activity Pacing | Fatigue-BFI | 3.35 units on a scale | Standard Deviation 2.13 |
| General Activity Pacing | Fatigue-BFI | 3.09 units on a scale | Standard Deviation 2.14 |
| Usual Care Group | Fatigue-BFI | 2.98 units on a scale | Standard Deviation 2.28 |
Primary
Fatigue-BFI
This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score indicates worse fatigue.
Time frame: 6 months post-baseline
Population: Sample numbers may vary due to missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Activity Pacing | Fatigue-BFI | 3.30 units on a scale | Standard Deviation 2.36 |
| General Activity Pacing | Fatigue-BFI | 2.90 units on a scale | Standard Deviation 1.98 |
| Usual Care Group | Fatigue-BFI | 2.83 units on a scale | Standard Deviation 2.26 |
p-value: 0.85Mixed Models Analysis
Primary
Fatigue- Brief Fatigue Inventory (BFI)
This is a summary measure of fatigue severity and fatigue interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Activity Pacing | Fatigue- Brief Fatigue Inventory (BFI) | 3.06 units on a scale | Standard Deviation 2.34 |
| General Activity Pacing | Fatigue- Brief Fatigue Inventory (BFI) | 3.18 units on a scale | Standard Deviation 2.45 |
| Usual Care Group | Fatigue- Brief Fatigue Inventory (BFI) | 2.70 units on a scale | Standard Deviation 2.31 |
Primary
Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
This is a summary of reported pain in specific activities. It is 5 questions with answers ranging from 0 - 4. Total possible score is 20 in which a higher score is worse pain.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Activity Pacing | Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 8.23 units on a scale | Standard Deviation 2.99 |
| General Activity Pacing | Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 8.19 units on a scale | Standard Deviation 3.37 |
| Usual Care Group | Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 8.27 units on a scale | Standard Deviation 3.32 |
Primary
Pain- WOMAC
This is a 5-item pain scale in which scores from 0 - 4 are summed. A higher score indicates more pain.
Time frame: 10 weeks post-baseline
Population: Sample numbers may differ due to missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Activity Pacing | Pain- WOMAC | 8.10 units on a scale | Standard Deviation 3.43 |
| General Activity Pacing | Pain- WOMAC | 7.16 units on a scale | Standard Deviation 3.11 |
| Usual Care Group | Pain- WOMAC | 7.83 units on a scale | Standard Deviation 3.46 |
Primary
Pain- WOMAC
This is a 5 item pain scale in which items on a scale of 0 - 4 are summed. A higher score means more pain.
Time frame: 6 months post baseline
Population: Numbers may vary due to missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Activity Pacing | Pain- WOMAC | 7.63 units on a scale | Standard Deviation 3.57 |
| General Activity Pacing | Pain- WOMAC | 7.33 units on a scale | Standard Deviation 2.76 |
| Usual Care Group | Pain- WOMAC | 6.68 units on a scale | Standard Deviation 3.29 |
p-value: 0.06Mixed Models Analysis
Secondary
Physical Function- Six Minute Walk
Six minute walk is the distance (in feet) that people walk at a usual pace over 6 minutes
Time frame: Baseline
Population: Numbers may vary due to missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Activity Pacing | Physical Function- Six Minute Walk | 1185.3 feet | Standard Deviation 263.3 |
| General Activity Pacing | Physical Function- Six Minute Walk | 1208.6 feet | Standard Deviation 255.2 |
| Usual Care Group | Physical Function- Six Minute Walk | 1209.4 feet | Standard Deviation 260.1 |
Secondary
Physical Function- Six Minute Walk
This is the distance in feet that people walk over 6 minutes.
Time frame: 10 weeks post-baseline
Population: Numbers may differ due to missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Activity Pacing | Physical Function- Six Minute Walk | 1200.5 feet | Standard Deviation 260.1 |
| General Activity Pacing | Physical Function- Six Minute Walk | 1249.4 feet | Standard Deviation 217.3 |
| Usual Care Group | Physical Function- Six Minute Walk | 1236.1 feet | Standard Deviation 246.1 |
Secondary
Physical Function- Six Minute Walk
This is the distance people walk in feet over 6 minutes
Time frame: 6 months post baseline
Population: Numbers may differ due to missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Activity Pacing | Physical Function- Six Minute Walk | 1225.4 feet | Standard Deviation 240.1 |
| General Activity Pacing | Physical Function- Six Minute Walk | 1264.3 feet | Standard Deviation 192.9 |
| Usual Care Group | Physical Function- Six Minute Walk | 1222.4 feet | Standard Deviation 265.6 |
p-value: 0.36Mixed Models Analysis