Condition category
Signs and Symptoms
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Mary Ersek


Contact details

550 16th Ave
Suite 405
United States of America

Additional identifiers

EudraCT number number

Protocol/serial number

5 RO1 NR007787-02

Study information

Scientific title


PSM Study

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet


Chronic pain


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



Not Specified

Drug names

Primary outcome measures

Roland-Morris Disability Questionnaire (RMDQ)

Secondary outcome measures

1. Brief Pain Inventory (BPI)
2. Geriatric Depression Scale (GDS)

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants


Participant exclusion criteria

Current, active cancer

Recruitment start date


Recruitment end date



Countries of recruitment

United States of America

Trial participating centre

550 16th Ave
United States of America

Sponsor information


NIH/National Institute of Nursing Research (USA)

Sponsor details

Bldg. 45
Rm 3AN12
45 Center Drive
MSC 6300
United States of America

Sponsor type




Funder type


Funder name

National Institutes of Health (NIH) (USA) (ref: 5 RO1 NR007787-02)

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

federal/national government


United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. Protocol in
2. Descriptive study results in
3. RCT results in

Publication citations

  1. Protocol

    Ersek M, Turner JA, Cain KC, Kemp CA, Chronic pain self-management for older adults: a randomized controlled trial [ISRCTN11899548]., BMC Geriatr, 2004, 4, 7, doi: 10.1186/1471-2318-4-7.

  2. Descriptive study results

    Kemp CA, Ersek M, Turner JA, A descriptive study of older adults with persistent pain: use and perceived effectiveness of pain management strategies [ISRCTN11899548]., BMC Geriatr, 2005, 5, 12, doi: 10.1186/1471-2318-5-12.

  3. RCT results

    Ersek M, Turner JA, Cain KC, Kemp CA, Results of a randomized controlled trial to examine the efficacy of a chronic pain self-management group for older adults [ISRCTN11899548]., Pain, 2008, 138, 1, 29-40, doi: 10.1016/j.pain.2007.11.003.

Additional files

Editorial Notes