Pain Management Following Musculoskeletal Injury

NCT01689675 | Completed

• 2 other identifiers: NA_000499271R01AR054009-01A1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

Musculoskeletal sprain/strain injuries and disorders (MSID) have a major impact on health, quality of life and societal productivity. Early intervention for pain following acute MSIDs may prevent secondary complications of chronic pain, disability, reduced quality of life or lost productivity. The investigators goal is to evaluate the efficacy of a computer-based self-management intervention for reducing pain and improving function in persons treated in on-site physical rehabilitation centers. The specific aims are:1) evaluate the efficacy of a computer-based self-management intervention in reducing pain and self-efficacy and function in high risk MSID patients; 2) determine long term impact during a six month follow-up period; and 3) determine whether reductions of pain and improved function translate into reductions in lost work time days away from work, restricted work days, worker's compensation costs and re-injury rates during the 6 month follow-up. Persons with sprain/strain injuries at risk for poor pain control will randomized to either: 1) control condition - standard care in the rehabilitation center plus computer exposure or 2) standard care plus computer-based self-management pain intervention. Assessment will be at baseline, treatment completion, 3 and 6 months. The primary outcome measures are self-efficacy, pain and physical/psychosocial functioning and secondary outcome measures are days away from work, restricted work days worker's compensation costs and re-injury rates. The investigation will also provide unique and valuable information regarding patients acceptance and use of computer-based interventions following acute injury. By establishing the utility and efficacy of computer-based pain management interventions for MSID the investigators have the potential to improve the health and quality of life of persons with injuries, improve productivity and develop new methods for health care delivery.

Conditions

Musculoskeletal Strain; Musculoskeletal Sprain; Injury of Musculoskeletal System

Keywords

musculoskeletal; pain; pain management; computer based intervention

Outcome Measures

Primary Outcomes (2)

• Pain

  Pain will be measured using the Brief Pain Inventory, which includes 4 pain items assessing current, worst, least, and average pain (0-no pain to 10-as bad as you can imagine) during the past week. This scale has excellent reliability and validity in a wide variety of acute and chronically painful conditions. In addition to measuring pain severity, 10 items measure pain-related interference in daily activities (0-does not interfere to 10-completely interferes) which also shows excellent reliability and validity in a wide variety of acute and chronically painful conditions.

  3 month followup

• Physical and Psychosocial Function

  The SF-12 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-12 includes items that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. A total score and two subscales scores are calculated -physical function and psychosocial function. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer, self-report, or by telephone.

  3 month followup

Secondary Outcomes (1)

• Work Productivity

  3 month followup

Other Outcomes (4)

• Catastrophizing

  3 month followup

• Self-Efficacy

  3 month followup

• Fear-avoidance beliefs

  3 month followup

Study Arms (2)

Computer based pain management

EXPERIMENTAL

The computer-based self-management program (CBSM) intervention will be administered over 8 sessions during the average 4 week period patients are receiving their standard on-site rehabilitation care. Patients will come to the center to receive their standard care and then interact with the computer for the 25-30 minute CBSM intervention. The primary goals of treatment include developing skills for managing acute injury and related pain including: reducing fear avoidance beliefs and catastrophizing, improving mood, increasing perceptions of control and self-efficacy, maintaining activity and reducing pain. Skills are presented and modeled by computer-based video during sessions, audio will be used to explain models and teach skills such as relaxation training.

Behavioral: Computer based pain management

Education control

ACTIVE COMPARATOR

The computer exposure will be administered over 8 sessions during the average 4-week period patients are receiving their standard on-site rehabilitation care. Patients will come to the center to receive their standard care and then interact with the computer for the 25-30 minute control condition. The primary goal of this condition is to provide a control for computer exposure. Briefly, the first session will concentrate on establishing the patient's ability to interact with the computer. The materials will provide general education regarding the injury and methods for preventing re-injury. This condition will not provide teaching and practice of specific pain management and coping management skills. This control computer education activity will equalize the computer exposure of the two groups and the duration of time devoted to injury care.

Behavioral: Computer based pain management

Interventions

Computer based pain management BEHAVIORAL

Computer based pain management; Education control

Eligibility Criteria

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

You may qualify if:

• age 18 years or older
• Musculoskeletal sprain/strain injury
• pain level greater or equal to 5
• English speaking

You may not qualify if:

• Age \< 18
• non-English speaking

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Stephen T Wegener, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 21, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

US (2)