Chronic Pain Self-Management (PSM) for the elderly
| ISRCTN | ISRCTN11899548 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11899548 |
| Protocol serial number | 5 RO1 NR007787-02 |
| Sponsor | NIH/National Institute of Nursing Research (USA) |
| Funder | National Institutes of Health (NIH) (USA) (ref: 5 RO1 NR007787-02) |
- Submission date
- 20/05/2004
- Registration date
- 28/07/2004
- Last edited
- 31/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mary Ersek
Scientific
Scientific
550 16th Ave
Suite 405
Seattle
98122
United States of America
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | PSM Study |
| Study objectives | The primary goal of this study is to evaluate the efficacy of a pain self-management group intervention (SMG), as compared with a control condition (BOOK), in decreasing physical disability, pain, pain-related interference with activities, and depression in older retirement community residents with chronic pain. The hypotheses are as follows: 1. At post-treatment and each follow-up, participants assigned to SMG, as compared with participants assigned to BOOK, will report less physical disability (primary outcome), and lower pain intensity, pain-related interference with activities, and depressive symptom severity (secondary outcomes) 2. Participants assigned to SMG, as compared with participants assigned to BOOK, will show greater pre- to post-treatment increases in self-efficacy and use of adaptive pain coping strategies and greater decreases in catastrophizing. Significant differences between SMG and BOOK groups in pain-related beliefs and coping strategies will be maintained at 6-month and 1-year follow-ups. 3. Pre- to post-treatment changes in specific pain-related beliefs (catastrophizing, self-efficacy) and coping strategies (Chronic Pain Coping Inventory subscales) will be associated significantly with changes in physical and social functioning, pain intensity, and depression over the same period among SMG participants. These changes in beliefs and coping strategies will be maintained at 6-month and 1-year follow-ups. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Chronic pain |
| Intervention | After all participants from a facility have completed the baseline questionnaires, the facility is randomised to receive either the BOOK or the SMG. SMG intervention: This consists of seven weekly 90-minute group sessions. The SMG group facilitator telephones each participant at 12, 16, 22, and 30 weeks after the final group session. During the booster phone calls, facilitators inquire about pain and functioning, current pain management plans, and successes and obstacles in meeting pain management goals, as well as provide encouragement and assistance in problem-solving obstacles encountered in pain management. BOOK intervention: Participants receive a copy of The Chronic Pain Workbook, 2nd Edition. Facilitators telephone participants 1 and 4 weeks after participants receive the workbook. BOOK participants receive follow-up phone calls at the same intervals to control for attention. |
| Intervention type | Other |
| Primary outcome measure(s) |
Roland-Morris Disability Questionnaire (RMDQ) |
| Key secondary outcome measure(s) |
1. Brief Pain Inventory (BPI) |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 273 |
| Key inclusion criteria | 1. Adults 65 years or older 2. Non-cancer musculoskeletal pain greater than three months duration that interferes with daily activities 3. Can read and comprehend questionnaires in English 4. No or minimal cognitive impairment 5. Have not had surgery within the past six months 6. Do not have surgery planned in the next six months |
| Key exclusion criteria | Current, active cancer |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/01/2005 |
Locations
Countries of recruitment
- United States of America
Study participating centre
550 16th Ave
Seattle
98122
United States of America
98122
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Descriptive study results | 08/11/2005 | Yes | No | |
| Results article | RCT results | 15/08/2008 | Yes | No | |
| Protocol article | Protocol | 30/07/2004 | Yes | No |
