Trial record 15 of 92 for:    fibromyalgia | Open Studies | Exclude Unknown

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Warren Nielson, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01674335
First received: August 17, 2012
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Fibromyalgia
Chronic Pain
Chronic Fatigue
Behavioral: Operant Learning
Behavioral: Energy Conservation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Operant Learning Versus Energy Conservation Activity Pacing Interventions in a Sample of Fibromyalgia Patients: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Pain ratings (0-10 numerical rating scale assessing average pain over the last 7 days) [ Time Frame: 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)). ] [ Designated as safety issue: No ]
    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).

  • Fatigue ratings (0-10 numerical rating scale assessing average fatigue over the last 7 days) [ Time Frame: 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)). ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Socio-demographic questionnaire [ Time Frame: Pretreatment (T0). ] [ Designated as safety issue: No ]
    Information on sex, age, ethnicity, civil status, education, work status, income, will be collected

  • Brief Pain Inventory [ Time Frame: 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)). ] [ Designated as safety issue: No ]
    Questionnaire measuring pain interference in different life aspects.

  • Brief Fatigue Inventory [ Time Frame: 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)). ] [ Designated as safety issue: No ]
    Questionnaire measuring fatigue interference in different life aspects.

  • SF36v2 Health Survey [ Time Frame: 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)). ] [ Designated as safety issue: No ]
    Questionnaire measuring quality of life.

  • Medical Outcomes Study (MOS) - Sleep scale [ Time Frame: 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)). ] [ Designated as safety issue: No ]
    Questionnaire measuring sleep problems.

  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 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)). ] [ Designated as safety issue: No ]
  • Structured Assessment [ Time Frame: Pretreatment (T0) ] [ Designated as safety issue: No ]
    Information on current medications and health care utilization, fibromyalgia characteristics (symptoms, duration etc.), chronic pain and fatigue family history as well as comorbid mental and physical condition.


Other Outcome Measures:
  • Coping Strategies Questionnaire (CSQ) (Short-Form 2 items) [ Time Frame: 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)). ] [ Designated as safety issue: No ]
  • Multidimensional Pain Readiness to Change Questionnaire (MPRCQ2) - Pacing scale [ Time Frame: 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)). ] [ Designated as safety issue: No ]
  • Survey of Pain Attitudes (SOPA) (Short-Form 2 items) [ Time Frame: 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)). ] [ Designated as safety issue: No ]
  • Patterns of Activity - Pain (POAM-P) [ Time Frame: 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)). ] [ Designated as safety issue: No ]
  • Patients' Global Impression of Change (PGIC) [ Time Frame: PretreatmentPost-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)). ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Delayed-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.
Active Comparator: Operant Learning Behavioral: Operant Learning

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.

Other Names:
  • Activity pacing
  • Grade activity
Active Comparator: Energy Conservation Behavioral: Energy Conservation

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.

Other Names:
  • Activity pacing
  • Energy envelope

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674335

Contacts
Contact: Warren Nielson, Ph.D. 1-519-646-6000 ext 61038 warren.nielson@sjhc.london.on.ca
Contact: Racine Mélanie, Ph.D. 1-519-702-9519 melanie.racine@gmail.com

Locations
Canada, Ontario
St. Joseph's Health Care London Not yet recruiting
London, Ontario, Canada, N6A 4V2
Contact: Nielson         
St. Joseph's Health Care London Not yet recruiting
London, Ontario, Canada, N6A 4V2
Contact: Warren Nielson, Ph.D.    1-519-646-6000 ext 61038    warren.nielson@sjhc.london.on.ca   
Contact: Mélanie Racine, Ph.D.    1-519-702-9519    melanie.racine@gmail.com   
Principal Investigator: Warren Nielson, Ph.D.         
Sub-Investigator: Mélanie Racine, Ph.D.         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: 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
  More Information

Publications:

Responsible Party: Warren Nielson, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01674335     History of Changes
Other Study ID Numbers: PACING-2012
Study First Received: August 17, 2012
Last Updated: August 24, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Fibromyalgia
Chronic pain
Chronic fatigue
Activity pacing
Operant learning
Energy conservation
Treatment
Intervention
Biopsychosocial factors
Coping
Mood
Quality of life

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Chronic Pain
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Rheumatic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 19, 2015