The Effectiveness of Operant Learning Versus Energy Conservation Activity Pacing Treatments in Fibromyalgia

NCT01674335 | Completed

• 1 other identifier: PACING-2012
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Activity pacing (AP) is a commonly used treatment for people with chronic pain. Many people with pain try to continue their daily activities at the same level as they were able to manage before they had pain. This way of coping causes increases in their pain; they become discouraged and give up on their activities. AP treatments involve helping them regulate their activity level so that they can achieve important life goals. Although AP is widely used, its effectiveness is still unproven. There are two key approaches: The operant learning (OL) approach uses quotas related to time or goals the person sets. The energy conservation (EC) approach focuses on balancing patient energy expenditure. Both of these treatments have often been used with people with Fibromyalgia Syndrome (FMS), a common pain condition. We will examine the effects of these treatments on pain, fatigue, quality of life, physical functioning and mental well-being. We will also investigate whether other factors influence treatment effectiveness (e.g., a person's readiness to change, pain intensity level). 120 FMS patients will be randomly assigned to receive OL, EC, Delayed-OL or Delayed-EC. Data will be collected at baseline, at the end of treatment and at 3, 6 and 12 month follow-ups. FMS patients will be recruited consecutively from Rheumatologists at St. Joseph's Health Care London. OL and EC treatment manuals will be developed by experts in the field and both interventions will be given by two occupational therapists over a 3 month period as "stand-alone" interventions (10 sessions of 120 min). All sessions will be recorded in order to assess intervention fidelity. This study will be the first to base AP interventions on a clearly delineated theoretical framework. It will clarify whether AP strategies benefit individuals with FMS and whether either of these two approaches is more effective. Our results will help to direct clinical resources and funding toward the most beneficial interventions.

Conditions

Fibromyalgia; Chronic Pain

Keywords

Fibromyalgia; Chronic pain; Chronic fatigue; Activity pacing; Operant learning; Energy conservation; Treatment; Intervention; Biopsychosocial factors; Coping; Mood; Quality of life

Outcome Measures

Primary Outcomes (2)

• Pain ratings (0-10 numerical rating scale assessing average pain over the last 7 days)

  This study used multiple primary endpoints (pain and fatigue) as we consider both variables as important on a clinical point of view. Both measures are rate or a 0 to 10 numerical scale where 0= no pain or no fatigue and 10=worst pain or worst fatigue as bad as they can imagine. Significant clinical changes of both pain and fatigue are consider to be 1) minimal if the reduction on the scale is between 1 or 2 points, 2) moderate if the reduction is ≥ 3 points, and 3) substantial improvement if the reduction is ≥ 5 points. Change in pain will be calculated by subtracting the earlier time point (T0) from each of the subsequent time points(T1 to T4).

  Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).

• Fatigue ratings (0-10 numerical rating scale assessing average fatigue over the last 7 days)

  This study used multiple primary endpoints (pain and fatigue) as we consider both variables as important on a clinical point of view. Both measures are rate or a 0 to 10 numerical scale where 0= no pain or no fatigue and 10=worst pain or worst fatigue as bad as they can imagine. Significant clinical changes of both pain and fatigue are consider to be 1) minimal if the reduction on the scale is between 1 or 2 points, 2) moderate if the reduction is ≥ 3 points, and 3) substantial improvement if the reduction is ≥ 5 points. Change in fatigue will be calculated by subtracting the earlier time point (T0) from each of the subsequent time points(T1 to T4)

  Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).

Secondary Outcomes (7)

• Socio-demographic questionnaire

  Pretreatment (T0).

• Brief Pain Inventory

  Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).

• Brief Fatigue Inventory

  Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).

• SF36v2 Health Survey

  Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).

• Medical Outcomes Study (MOS) - Sleep scale

  Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).

Other Outcomes (5)

• Coping Strategies Questionnaire (CSQ) (Short-Form 2 items)

  Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).

• Multidimensional Pain Readiness to Change Questionnaire (MPRCQ2) - Pacing scale

  Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).

• Survey of Pain Attitudes (SOPA) (Short-Form 2 items)

  Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)).

Study Arms (3)

Delayed-Intervention

NO INTERVENTION

A total of 120 participants with fibromyalgia will be randomly assigned to one of four intervention groups (Operant Learning (OL), Energy Conservation (EC), delayed-OL and delayed-EC). The delayed groups will receive the AP intervention 3 months later and will serve as a Usual Care control group. All groups will continue to receive any concomitant interventions that they are receiving (pharmacological and non-pharmacological) at the time of enrollment.

Operant Learning

ACTIVE COMPARATOR

Behavioral: Operant Learning

Energy Conservation

ACTIVE COMPARATOR

Behavioral: Energy Conservation

Interventions

Operant Learning BEHAVIORAL

The present therapist manual focuses on the operant learning approach, which emphasizes the use of positively reinforced activity quotas that are time and/or goal contingent, rather than pain-contingent, using a gradually increased "activity-rest" cycling approach (Fordyce, 1976). This manual includes a total of 10 group sessions (duration: 2 hours each), two booster sessions at 3 and 6 months post-intervention (duration: 1 hour each) and a 1 follow-up session at 12 months post-intervention (duration: 1 hour). The 10 group sessions are held on a weekly basis for the 2 first months, and every 2 weeks for the remaining 3rd months.

Also known as: Activity pacing, Grade activity

Operant Learning

Energy Conservation BEHAVIORAL

The present therapist manual focuses on the energy conservation approach, which emphasizes management of participant energy expenditure, and seeks to achieve a balance between accomplishing important day-to-day activities and resting in order to reduce or avoid pain and fatigue (Hammond, 2004). This manual includes a total of 10 group sessions (duration: 2 hours each), two booster sessions at 3 and 6 months post-intervention (duration: 1 hour each) and a 1 follow-up session at 12 months post-intervention (duration: 1 hour). The 10 group sessions are held on a weekly basis for the 2 first months, and every 2 weeks for the remaining 3rd months.

Also known as: Activity pacing, Energy envelope

Energy Conservation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or over
• Presenting a formal diagnosis of FMS meeting either the American College of Rheumatology 1990 criteria or the 2010 clinical diagnostic criteria
• Able to provide informed consent
• Able to read, understand and answer questionnaires in English
• Available for follow-up booster sessions during a 12 months period

You may not qualify if:

• Have previously participated in a formal activity pacing intervention
• Present psychological comorbidity that might interfere with the activity pacing group sessions
• Present cognitive impairment that would prevent benefiting from the activity pacing group sessions

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

Location

Related Publications (18)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  PMID: 2306288 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Conservation of Energy Resources

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Conservation of Natural Resources; Environment; Environment and Public Health

Study Officials

• Warren Nielson, Ph.D.

  Lawson Health Research Institue and St. Joseph's Health Care London

  PRINCIPAL INVESTIGATOR

• Mélanie Racine, Ph.D.

  Lawson Health Research Institute and St. Joseph's Health Care London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2012
• First Posted: August 28, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 2, 2015

Record last verified: 2015-08

Locations

CA (1)