Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis

Pain Clinical Trial

— AIM  

Official title:

Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192516
• Other study ID #: E7557-R
• Status: Completed
• Phase: N/A
• First received: August 25, 2010
• Last updated: March 18, 2015
• Start date: January 2010
• Est. completion date: September 2013

Study information

• Verified date: March 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 exclusion criteria that, by the opinion of the study personnel, would make the participant unable to safely or effectively complete the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Pain

Intervention

Behavioral:
• Tailored Activity Pacing
Therapeutic intervention will be based on a tailored approach using collected data on symptom and activity patterns of each participant.
• General Activity Pacing
Therapeutic intervention using generalized pacing instruction to manage symptoms

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline	No
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.	10 weeks post-baseline	No
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.	6 months post-baseline	No
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.	Baseline	No
Primary	Pain- WOMAC	This is a 5-item pain scale in which scores from 0 - 4 are summed. A higher score indicates more pain.	10 weeks post-baseline	No
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.	6 months post baseline	No
Secondary	Physical Function- Six Minute Walk	Six minute walk is the distance (in feet) that people walk at a usual pace over 6 minutes	Baseline	No
Secondary	Physical Function- Six Minute Walk	This is the distance in feet that people walk over 6 minutes.	10 weeks post-baseline	No
Secondary	Physical Function- Six Minute Walk	This is the distance people walk in feet over 6 minutes	6 months post baseline	No