A Prospective Observational Pilot Study: Evaluating the Impact of a Breakthrough Pain Action Plan on the Use of Breakthrough

MedicationsLuzhi Yan, BSc(Pharm); Donna K Buna, BSc(Pharm), PharmD

Methods

Results Discussion

Conclusion

References available on request

Pain is multi-factorial involving both physical and psychosocial factors.

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

→ 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

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

Introduction

Study Objectives

Results

Figure 4: Nondrug intervention breakdown

Recruitment and Baseline Demographics

Figure 2: Average daily doses of breakthrough medications used

Parameter N=5

Type of painNo. (%)

Lower back pain 1 (20)

Neuropathic 3 (60)

Mixed 1 (20)Avg duration of chronic pain (mo) 141.6

Avg age (yrs) 46.4Male (%) 40Comorbid psychiatric illness (%) 40

Pain score at baseline - numerical rating scale (NRS) 7

Reasons for Exclusion:

• Regimen change 4• No BTP meds 2• No pain series 1• Declined/withdrew 3

N=15

N=10

N=5

ScreeningScreening

ExclusionsExclusions

Baseline interviewConsent, demographics, medication history, primary pain diagnosis, duration of chronic pain, comorbidities, set-up one week self-assessment phase

Baseline interviewConsent, demographics, medication history, primary pain diagnosis, duration of chronic pain, comorbidities, set-up one week self-assessment phase

One-week baseline daily self-assessment

One-week baseline daily self-assessment

Patient interventionPatient intervention

One-week post-intervention daily self-assessment

One-week post-intervention daily self-assessment

Post-study follow-upPost-study follow-up

2nd interviewDevelopment of BTP Action Plan with study investigators, set-up time for patient’s one week post-intervention self-assessment; initiate intervention

2nd interviewDevelopment of BTP Action Plan with study investigators, set-up time for patient’s one week post-intervention self-assessment; initiate intervention

1 week

4 weeks

1 week

6 months post-study

Table 1: Baseline demographics

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)

6-months post-study follow-up- Questionnaire to determine satisfaction/compliance with Action Plan- To be completed (TBC)

Figure 3: Overall pain score (NRS)

*Meditation and controlled breathing were often combined as a single item on the action plan

Positive thinking 4.8%

Ice therapy 9.5%

*

*

Mobility ( /40)

Patient 1 No data

Patient 2 0

Patient 3 -1

Patient 4 0

Patient 5 -4

Vitality ( /30)

Patient 1 No data

Patient 2 -5

Patient 3 -3

Patient 4 5

Patient 5 -4

Psychosocial ( /50)

Patient 1 No data

Patient 2 -1

Patient 3 -2

Patient 4 10

Patient 5 0

Table 2: Changes in POQ

*Negative number indicates an improvement in parameter

Mobility: ability to walk, carry items, climb stairs and use of walking aid

Vitality: perception of overall energy, physical activity and endurance

Psychosocial: rating of feelings of depression, anxiety, self-esteem concentration and tension

Figure 1: Recruitment flow chart

N=4

Findings

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

- 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

Did not complete

Did not complete

Outcome Measure Result

Average daily BTP medication ↓ by 1.25 doses (38%)

Average daily morphine equivalents ↓ by 10.3 mg (40%)

Overall pain and function Not adversely affected

Preferred behavioural interventionsMeditation, controlled breathing, heat therapy

Long-term sustainability - 6-month post-study data TBC- Extension of recruitment to increase sample size

Feasibility of conducting a larger, more robust study in this area

Design - Prospective, observational pilot study- Single center: VIHA Pain Program

Study population

Inclusion Exclusion

- 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

- 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

Uniqueness of Research