NCT00636454

Brief Summary

Osteoarthritis (OA) is the leading cause of disability in the United States. Studies have shown that training patients to cope with pain improves physical and social functioning, increases self-efficacy, and reduces psychological distress. However, this type of training is not available to the vast majority of OA patients. This study will determine the effectiveness of a training program for coping with pain that will be administered in community medical practices. A THIRD ARM OF THE TRIAL WAS FUNDED 09/09. TREATED PATIENTS WILL BE RANDOMIZED TO (1)A 4-MONTH COMPUTER-DRIVEN TELEPHONE PROGRAM TO ENHANCE MAINTANENCE OF TREATMENT GAINS OR (2)USUAL CARE. THIS ARM WILL ONLY BE CONDUCTED AT THE STONY BROOK SITE.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
257

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2008

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 27, 2013

Status Verified

September 1, 2013

Enrollment Period

5.1 years

First QC Date

March 12, 2008

Last Update Submit

September 25, 2013

Conditions

Osteoarthritis

Keywords

OAPainCognitive TherapyBehavior TherapyKnee OAHip OA

Outcome Measures

Primary Outcomes (6)

  • Pain

    Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups

  • Physical disability

    Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups

  • Psychological disability

    Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups

  • Self-efficacy

    Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups

  • Use of coping strategies

    Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups

  • Quality of life

    Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups

Secondary Outcomes (2)

  • Cost effectiveness of treatment

    Measured at 12-month follow-up

  • RE-AIM measures of treatment fidelity

    Throughout the study

Study Arms (2)

1

ACTIVE COMPARATOR

This group will serve as the control group and will receive only the care usually given to OA patients.

Other: Usual care

2

EXPERIMENTAL

This group will take part in the 10-session treatment program that will teach patients cognitive and behavioral skills to cope with pain.

Behavioral: Coping skills training (CST) for chronic pain

Interventions

Coping skills training (CST) for chronic painBEHAVIORAL

Participants will attend 10 sessions lasting between 45 and 60 minutes each. Topics will include relaxation training, managing activity cycles, and changing thought patterns to reduce the negative effects of pain.

2
Usual careOTHER

Participants will receive the care usually given to patients with knee or hip OA.

1

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient in one of the two recruitment community clinics
  • Diagnosis of knee or hip OA
  • History of pain greater than or equal to a 4 on a 10-point scale for at least 6 months prior to study entry
  • Able to read, write, and understand English
  • Absence of significant psychiatric or cognitive dysfunction
  • Able to attend 10 treatment sessions
  • Access to telephone to complete interactive voice response (IVR) ratings and possible phone sessions
  • Completion of baseline assessment

You may not qualify if:

  • Scheduled for joint replacement surgery within the 18 months following study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Stony Brook Primary Care

Setauket, New York, 11733, United States

Location

Rheumatology Associates of Long Island

Smithtown and Port Jefferson, New York, United States

Location

Piedmont Primary Care

Danville, Virginia, United States

Location

MeSH Terms

Conditions

OsteoarthritisPainOsteoarthritis, Hip

Interventions

galactosylceramide sulfotransferase

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joan E. Broderick, PhD

    Stony Brook University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 14, 2008

Study Start

May 1, 2008

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

September 27, 2013

Record last verified: 2013-09

Locations

US(3)