Pain Management Following Musculoskeletal Injury
|ClinicalTrials.gov Identifier: NCT01689675|
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : October 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Musculoskeletal Strain Musculoskeletal Sprain Injury of Musculoskeletal System||Behavioral: Computer based pain management||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Pain Management Following Musculoskeletal Injury|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||December 2013|
Experimental: Computer based pain management
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|
Active Comparator: Education control
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|
- Pain [ Time Frame: 3 month followup ]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.
- Physical and Psychosocial Function [ Time Frame: 3 month followup ]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.
- Work Productivity [ Time Frame: 3 month followup ]Work productivity will be measured by the number of days away from work, restricted work days, and Worker's compensation costs related to this incident of care. Due to the lost productivity and worker compensation cost associated with MSID, it is critical to include these measures in the outcome analyses 10. In addition, the number of re-injuries that occur following treatment will also be included as an outcome measure. These data are available through contacting Worker's Compensation intermediary. We have experience accessing, manipulating and analyzing these data for previous program evaluation cost benefit analyses.
- Catastrophizing [ Time Frame: 3 month followup ]The Pain Catastrophizing Scale will be used to measure catastrophic thinking related to pain. Respondents rate the frequency with which they experience 13 different thoughts and feelings related to pain. The scale has been shown to be reliable (alpha =.87) and has been associated with pain levels, self-reported disability and employment status.
- Self-Efficacy [ Time Frame: 3 month followup ]There is evidence that enhancement of perceived self- efficacy may mediate pain control and improved psychosocial functioning in persons who participate in self-management intervention. Self-efficacy for pain management will be measured using the Pain Self-Efficacy scale which includes subscales that measure self-efficacy for pain management, self-efficacy for coping with symptoms, and self-efficacy for physical function.
- Fear-avoidance beliefs [ Time Frame: 3 month followup ]This variable will be measured with 2 questionnaires: 1) The Tampa Scale of Kinesiophobia (TSK), which has been shown to be a relevant measure of fear of movement/activity; 2) A modified form of the Fear-Avoidance Behavior Questionnaire that contains four items from the physical activity scales. These measures have both been associated with long term pain and work disability in acutely injured individuals.
- Utility and Use of Intervention Materials [ Time Frame: 4 weeks after starting treatment ]The use of computers for delivery of the intervention allows for ongoing monitoring of intervention activity materials. Quantitative metrics will be collected as part of the intervention including sessions attended, the amount of the program completed in each session, and utilization of Support Services (time on bulletin board and number of postings). Utilization of the website containing the intervention, Support Service and assessment materials will be evaluated for (1) the effectiveness with which users can accomplish tasks; (2) the speed with which users can find the information they are seeking and navigate through the elements of the prototype session; (3) the paths users take to complete a task; and 4) users' satisfaction level using the interactive tools. Qualitative data to be collected includes: user comments, concerns, frustrations, and suggestions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689675
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Stephen T Wegener, PhD||Johns Hopkins University|