Transcript pain and overall

A Prospective Observational Pilot Study: Evaluating the Impact of a
Breakthrough Pain Action Plan on the Use of Breakthrough Medications
Luzhi Yan, BSc(Pharm); Donna K Buna, BSc(Pharm), PharmD
Introduction
Results
Recruitment and Baseline Demographics
Pain is multi-factorial involving both physical and psychosocial factors.
N=15
Breakthrough pain (BTP)
- Occurs in 48-70% of patients with chronic noncancer pain
- Contributes to pain-related distress, functional impairment, depression and
relatively poor quality of life
- Often treated with short-acting analgesics (usually opioids)
- Typical episode peaks at 3 minutes, lasts approximately 30 minutes
- Strategies such as heat and ice therapy, music, relaxation, distraction,
cognitive reframing and massage therapy have been described in the literature
to have beneficial effects for both pain and anxiety
Screening
Reasons for Exclusion:
Exclusions
N=10
Baseline interview
Consent, demographics,
medication history, primary pain
diagnosis, duration of chronic
pain, comorbidities, set-up one
week self-assessment phase
•
•
•
•
Regimen change
No BTP meds
No pain series
Declined/withdrew
4
2
1
3
Table 1: Baseline demographics
Parameter
2nd
interview
Type of pain
No. (%)
Development of BTP Action Plan
with study investigators, set-up
time for patient’s one week postintervention self-assessment;
initiate intervention
N=4
Lower back pain
Neuropathic
Mixed
1 (20)
3 (60)
1 (20)
141.6
46.4
40
40
Avg age (yrs)
Male (%)
- Tertiary pain population → pain management remains a challenge despite
multiple trials of various analgesic and adjunctive medications
- Evaluating nondrug BTP management as part of an individualized action plan
using breakthrough medication use as an endpoint
- BTP Action Plan comprised of 5 nondrug measures chosen by the patient in
conjunction with study investigators
Comorbid psychiatric illness (%)
Patient intervention
Pain score at baseline - numerical
rating scale (NRS)
One-week post-intervention
daily self-assessment
1 week
7
6 months
post-study
Figure 1: Recruitment flow chart
Objective 1: To evaluate the effectiveness of an individualized BTP Action Plan
Outcome Measures:
- Average number of breakthrough medication doses per day
- Overall pain/function as reported by the pain outcomes questionnaire (POQ)*
- Preferred behavioural interventions as per BTP Action Plan and patient report
Objective 2: To determine the long-term sustainability of a BTP Action Plan in
chronic pain patients
Objective 3: To determine the feasibility of conducting a larger, more robust study
in this area
*POQ is a 20-point questionnaire used to assess pain and function (both physical and psychosocial)
and is validated in both acute and chronic pain syndromes
Baseline
Post-intervention
4.0
Did not
complete
1.0
0.0
Methods
2
3
4
Patient
5
Total
Figure 2: Average daily doses of breakthrough
medications used
Design
- Prospective, observational pilot study
- Single center: VIHA Pain Program
Baseline
10.0
Study population
Post-intervention
Inclusion
Exclusion
8.0
- 18 years of age and older
- Followed through VIHA Pain Program
- Chronic noncancer pain (excluding
headache) of at least 6 months
duration
- Using long-acting baseline PLUS 2 or
more short-acting breakthrough
analgesics per day
- Completion of the Pain Education
Series (or similar)
- Unable to read or write English
- Unable attend appointments in
person
- Change of pain medication regimen
in the 1 month before or anytime
during study phase
- Unwilling or unable to provide
informed written consent
6.0
Table 2: Changes in POQ
Mobility ( /40)
controlled breathing
were often combined
as a single item on the
action plan
Figure 4: Nondrug intervention breakdown
Descriptive analysis of nondrug measures used
- Use of each intervention varied depending on type of chronic pain
- Patient 2 with neuropathic pain (including TMJ) preferred self-massage
and meditation therapy
- Patient 3 with mixed lower back pain (LBP) and sciatica preferred
meditation, heat therapy and exercise therapy (short walks)
- Patient 4 with perianal neuropathic pain did not find any nondrug
measure to be particularly helpful
- Patient 5 with chronic LBP preferred deep breathing and rest (BTP often
caused by overexertion)
Outcome Measure
↓ by 1.25 doses (38%)
Average daily morphine equivalents
↓ by 10.3 mg (40%)
Overall pain and function
Not adversely affected
Meditation, controlled breathing,
heat therapy
No data
Patient 2
0
Patient 3
-1
Patient 4
0
Preferred behavioural interventions
Patient 5
-4
Long-term sustainability
Vitality ( /30)
Patient 1
No data
Patient 2
-5
Patient 3
-3
Patient 4
5
Patient 5
-4
Vitality: perception of overall energy,
physical activity and endurance
Result
Average daily BTP medication
Patient 1
Mobility: ability to walk, carry items,
climb stairs and use of walking aid
1
*Meditation and
Findings
5.0
2.0
Ice therapy
9.5%
Heat therapy
14.3%
Discussion
Results
3.0
Distraction
therapy
9.5%
6-months post-study follow-up
- Questionnaire to determine satisfaction/compliance with Action Plan
- To be completed (TBC)
Post-study follow-up
Study Objectives
Controlled
breathing *
14.3%
Self massage
4.8%
N=5
Avg duration of chronic pain (mo)
Uniqueness of Research
4 weeks
Exercise
9.5%
Stretches
4.8%
One-week baseline daily
self-assessment
1 week
Meditation *
19.0%
N=5
→ Promoted at VIHA Pain Program – Victoria Site
Potential downfalls of breakthrough medications use
- Pharmacokinetics of short-acting analgesics does not correlate well with BTP
- Higher peaks, theoretically equating to more acute adverse effects
- Opioid tolerance (tachyphylaxis) and dose escalation over time
- Overutilization of breakthrough medications past the titration phase
- Risk of abuse
Positive thinking
4.8%
Lying down
9.5%
Feasibility of conducting a larger,
more robust study in this area
- 6-month post-study data TBC
- Extension of recruitment to
increase sample size
Limitations
- Observational trial → definitive conclusions cannot be made regarding
the efficacy of behavioural interventions in pain management
- Small sample size → hypothesis generating at best; no formal statistical
analysis performed
- Patient reporting bias → no feasible objective measurements for pain,
thus must rely on patient self-reporting which may favour intervention
- Long-term benefits of using less breakthrough medication not assessed
Psychosocial ( /50)
4.0
Did not
complete
2.0
0.0
1
2
3
4
Patient
Figure 3: Overall pain score (NRS)
5
Total
Patient 1
No data
Patient 2
-1
Patient 3
-2
Patient 4
10
Patient 5
0
Psychosocial: rating of feelings of
depression, anxiety, self-esteem
concentration and tension
*Negative number indicates an
improvement in parameter
Conclusion
- Conclusive data cannot be drawn from this pilot study
- In the few patients analyzed, there appears to a reduction in BTP
medication use without adversely affecting pain and function
- Meditation, controlled breathing and heat therapy were the preferred
nondrug measures
- Long-term sustainability of BTP Action Plan to be completed
- Extension of recruitment and 6-months follow-up data is required to
determine feasibility of conducting a larger, more robust trial in this area
References available on request