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Effect Study of on Intervention on Pain, Function, Health and Behaviour for Older Adults Living With Chronic Pain

Primary Purpose

Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Individual tailored functional exercise
Standard care
Sponsored by
Oslo Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Pain focused on measuring chronic pain, community-dwelling, older adults, physical activity, physiotherapy, behavioural medicine, biopsychosocial, exercise, independency, everyday activities, self-efficacy, quality of life, pain-related beliefs, pain-related disability

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 75 years, Living in the central part of Oslo, Norway Living alone in ordinary housing Dependent on home help services for individual care and/or housekeeping activities or home care for medical needs The presence of musculoskeletal pain for three month or longer Ability to walk independently indoors, with or without a walking aid Ability to understand and speak Norwegian Ability to fill in activity diary or to have someone to help them with that.

Exclusion Criteria:

Older adults ongoing physiotherapy treatment for injury/illness, Are in a palliative stage of treatment Have experienced heart failure in the past three months.

Sites / Locations

  • Sara Cederbom

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individual tailored functional exercise

Standard care

Arm Description

Receives general advice about physical activity with the goal to be physically active at least 30 minutes per day at 5 of 7 days per week. The intervention group, which is based on a behavioural medicine approach in physiotherapy, also receive individual tailored functional exercise with the goal to enhance the ability to perform everyday activities by reduce pain-related disability and pain-related beliefs and increase physical function. The participants receive 9 visits from a physiotherapist during the 12 weeks period. The participants will also fill in a activity diary to check the compliance to the intervention and to enhance their self-efficacy in relation to perform everyday activities, exercise and physical activity.

The participants in the comparison Group will receive standard care which means that they receives one visit from physiotherapist where the participant receive general advice about physical activity with the goal to be physically active at least 30 minutes per day at 5 of 7 days per week. During intervention week 1-8 and 10 the participants receive telephone calls once a week where they will be reminded to follow the advice about physical activity.

Outcomes

Primary Outcome Measures

Pain-related disability measured with the pain interference score in Brief Pain Inventory (BPI)
Pain-related disability will be measured with the pain interference score in Brief Pain Inventory (BPI). The BPI is a self-report pain assessment tool and the patient is instructed to report pain as intensity and as interference with seven different functions. The interference scale includes seven items which assess pain's interference with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life. The BPI has shown to be The BPI is validated for use in older adults with non cancer pain.
Physical function measured by the Norwegian version of the Short Physical Performance Battery
Physical function will be measured by the Norwegian version of The short physical performance battery. The Short Physical Performance Battery (SPPB) evaluates balance, mobility and muscle strength by examining an individual's ability to stand with feet together in side-by side, semi-tandem and tandem positions, time to walk 8 ft and time to rise from a chair and return to the seated position five times. Each of the three tests is scored, based on performance between 0 and 4, leaving a maximum score of 12 for those individuals performing at the highest levels. The SPPB is a reliable and valid measure of lower extremity performance. Meaningful changes in the SPPB have been defined. Thus, the SPPB can be used as a standard measure of physical performance both for research and in clinical practice.

Secondary Outcome Measures

Reach of goal setting
For the participants in the intervention group will the following be checked: If the goal setting is reached or not will be measured by an Yes/No question
Pain severity measured by the BPI short version
Pain severity measured by the BPI short version. The BPI is a self-report pain assessment tool and the patient is instructed to report pain as intensity and as interference with seven different functions (49). The intensity scale contains four items measuring worst, least and average pain intensity (usually during the past 24 hours or past week) and intensity now.
Pain catastrophizing measured by the Catastrophizing subscale
will be measured with two items from the Catastrophizing subscale which is a part of the Coping strategies questionnaire.
Falls efficacy measured by the Norwegian version of the Falls-Efficacy Scale international (FES-I)
is measured by the Norwegian version of the Falls-Efficacy Scale international (FES-I). The FES-I assesses level of concern about falling on a 4 point scale during 16 activities of daily living. Scores range from 16 to 64 with higher scores indicating greater concern about falling.
physical activity level according to a six-point scale
The level of physical activity, including housekeeping activities, was estimated for the summer and winter seasons according to a six-point scale. The scale ranged from "hardly any physical activity" (level 1) to "hard exercise several times a week" (level 6). The scale has been shown to be valid for older people.
Health related quality of life measured with SF-12
will be measured with The Short Form Health survey,SF-12. SF-12 is a shortened version of SF-36 (55)) and has shown to be valid to use among older people.
Self-efficacy in relation to goal setting
The participants in the intervention Group will measure their self-efficacy in relation to the goal setting by and Self-efficacy in relation to the goal setting will be measured by a four-graded verbal descriptive scale; Not sure at all, little sure, rather sure, very sure.

Full Information

First Posted
October 21, 2016
Last Updated
April 18, 2018
Sponsor
Oslo Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT02953470
Brief Title
Effect Study of on Intervention on Pain, Function, Health and Behaviour for Older Adults Living With Chronic Pain
Official Title
Community-dwelling Older Adults Living With Chronic Musculoskeletal Pain: The Effect of an Evidence-based Intervention on Pain, Function, Health and Behaviour
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo Metropolitan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim for the study is to examined the effect of an individually tailored integrated behavioral medicine in physiotherapy intervention including functional exercise, for older adults, having chronic musculoskeletal pain, living alone and dependent on formal care. The study is a pragmatic randomized controlled trial with one intervention group and one control group. The intervention is a 12-weeks home-based program. The intervention consists of an individually tailored intervention and aims to enhance ability to perform everyday activities by improving physical function and reduce pain-related beliefs and pain-related disability. The comparison group achieves general advice about physical activity. All participants will be tested at baseline, a post-assessment at 12 week and a three month follow-up. Primary outcome is pain interference by the Brief Pain Inventory and physical function by Short Physical Performance Battery. Secondary outcomes measures if the goal setting is reached, self-efficacy in relation to the goal setting, pain catastrophizing, level of physical Activity, falls efficacy and Health related quality of life.
Detailed Description
Intervention group The base for the intervention is to identify a problematic everyday activity and identify factors, including physical, psychological and environmental factors, that can inhibit and/or promote the ability to perform the activity. The exercise that will improve the physical factors will be based on functional exercise such as Balance training and muscle strength training, e.g. fast walking in circle, marching on the spot with a high knee lift, leg lifts, power walking and stair walking, squats, lunge, turning trunk and head while standing, and walking over obstacles. Number of exercises and the dosage are based on how much the participant are able to do and want to do and will increase progressively considering the changes in function and health status of the participants. The content of the visits is as follow: Session: Identification of a problematic everyday activity and advice about physical activity. Session 2: Doing functional behavioural analyse including goal setting, discuss performance dosage of training. Session 3-5: Training in the basic physical and psychological skills relevant to goal setting. Session 6-9: Training to apply basic skills adequately for the goal setting, application of basic and applied skills to other behaviours, starting with subsequent activity goals. Discussion about how the participant can be able to maintain their new behaviour. Discussion of problem-solving strategies, how he/she can prevent and address new activity problems that may arise related to the goal setting and in relation to being physically active. During the intervention period will the participant receive visits by a physiotherapist during intervention weeks 1-8 and 12. Under week 10 will the participants receive one telephone call for support. Non-intervention Group The comparison group will receive standard care which means that the participants get one visit from physiotherapist which consist of written and oral information about general advice regarding physical Activity..Further will the comparison group receive telephone Calls to remind them of being physically active according to the advice during week 1-8 and week 10.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, community-dwelling, older adults, physical activity, physiotherapy, behavioural medicine, biopsychosocial, exercise, independency, everyday activities, self-efficacy, quality of life, pain-related beliefs, pain-related disability

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual tailored functional exercise
Arm Type
Experimental
Arm Description
Receives general advice about physical activity with the goal to be physically active at least 30 minutes per day at 5 of 7 days per week. The intervention group, which is based on a behavioural medicine approach in physiotherapy, also receive individual tailored functional exercise with the goal to enhance the ability to perform everyday activities by reduce pain-related disability and pain-related beliefs and increase physical function. The participants receive 9 visits from a physiotherapist during the 12 weeks period. The participants will also fill in a activity diary to check the compliance to the intervention and to enhance their self-efficacy in relation to perform everyday activities, exercise and physical activity.
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
The participants in the comparison Group will receive standard care which means that they receives one visit from physiotherapist where the participant receive general advice about physical activity with the goal to be physically active at least 30 minutes per day at 5 of 7 days per week. During intervention week 1-8 and 10 the participants receive telephone calls once a week where they will be reminded to follow the advice about physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Individual tailored functional exercise
Intervention Description
Receive individual tailored exercise to increase ability to perform everyday activities through increased physical function and self-efficacy in relation to be able to exercise and decreased pain-related beliefs such as fear of falling, catastrophizing thoughts and fear of movement.
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
Receives written and oral advice about physical Activity and the benefits of being physically active by one visits from a physiotherapist. Than will the participants receive Telephone reminder about following the advice once a week during intervention week 1-8 and 10.
Primary Outcome Measure Information:
Title
Pain-related disability measured with the pain interference score in Brief Pain Inventory (BPI)
Description
Pain-related disability will be measured with the pain interference score in Brief Pain Inventory (BPI). The BPI is a self-report pain assessment tool and the patient is instructed to report pain as intensity and as interference with seven different functions. The interference scale includes seven items which assess pain's interference with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life. The BPI has shown to be The BPI is validated for use in older adults with non cancer pain.
Time Frame
six month
Title
Physical function measured by the Norwegian version of the Short Physical Performance Battery
Description
Physical function will be measured by the Norwegian version of The short physical performance battery. The Short Physical Performance Battery (SPPB) evaluates balance, mobility and muscle strength by examining an individual's ability to stand with feet together in side-by side, semi-tandem and tandem positions, time to walk 8 ft and time to rise from a chair and return to the seated position five times. Each of the three tests is scored, based on performance between 0 and 4, leaving a maximum score of 12 for those individuals performing at the highest levels. The SPPB is a reliable and valid measure of lower extremity performance. Meaningful changes in the SPPB have been defined. Thus, the SPPB can be used as a standard measure of physical performance both for research and in clinical practice.
Time Frame
six month
Secondary Outcome Measure Information:
Title
Reach of goal setting
Description
For the participants in the intervention group will the following be checked: If the goal setting is reached or not will be measured by an Yes/No question
Time Frame
three month
Title
Pain severity measured by the BPI short version
Description
Pain severity measured by the BPI short version. The BPI is a self-report pain assessment tool and the patient is instructed to report pain as intensity and as interference with seven different functions (49). The intensity scale contains four items measuring worst, least and average pain intensity (usually during the past 24 hours or past week) and intensity now.
Time Frame
six month
Title
Pain catastrophizing measured by the Catastrophizing subscale
Description
will be measured with two items from the Catastrophizing subscale which is a part of the Coping strategies questionnaire.
Time Frame
six month
Title
Falls efficacy measured by the Norwegian version of the Falls-Efficacy Scale international (FES-I)
Description
is measured by the Norwegian version of the Falls-Efficacy Scale international (FES-I). The FES-I assesses level of concern about falling on a 4 point scale during 16 activities of daily living. Scores range from 16 to 64 with higher scores indicating greater concern about falling.
Time Frame
six month
Title
physical activity level according to a six-point scale
Description
The level of physical activity, including housekeeping activities, was estimated for the summer and winter seasons according to a six-point scale. The scale ranged from "hardly any physical activity" (level 1) to "hard exercise several times a week" (level 6). The scale has been shown to be valid for older people.
Time Frame
six month
Title
Health related quality of life measured with SF-12
Description
will be measured with The Short Form Health survey,SF-12. SF-12 is a shortened version of SF-36 (55)) and has shown to be valid to use among older people.
Time Frame
six month
Title
Self-efficacy in relation to goal setting
Description
The participants in the intervention Group will measure their self-efficacy in relation to the goal setting by and Self-efficacy in relation to the goal setting will be measured by a four-graded verbal descriptive scale; Not sure at all, little sure, rather sure, very sure.
Time Frame
three month
Other Pre-specified Outcome Measures:
Title
Consumer questions
Description
To assess the participants expected results of the intervention they will be asked to answer the following questions: How do you experience your physical activity level now after participation in the study? How do you experience your physical activity level now after participation in the study? 3) How are your physically problems now after ending the participation in the study? 4) Do you use what you learned during the intervention to manage or prevent your physically problem? 5) Describe how you use what you have learned to manage or prevent your physically problems 7) Do you take any pain medication more or less or the same Have you visit a physiotherapist Yes/no, if Yes, for what and what treatment did you get
Time Frame
at three and six month
Title
Age
Description
Age (years)
Time Frame
baseline
Title
Gender
Description
Gender; male/female
Time Frame
baseline
Title
Home-help services
Description
Number of home help services
Time Frame
baseline
Title
Home care
Description
Number of help from home care
Time Frame
baseline
Title
Medical diagnoses
Description
self-reported number Medical diagnoses
Time Frame
baseline
Title
Pain medication
Description
self-reported Number and use of pain medication
Time Frame
baseline
Title
Years With pain
Description
Number of years With pain
Time Frame
baseline
Title
Falls
Description
Number of falls last year
Time Frame
baseline
Title
Physical activity
Description
If the participants are so physically active as they wish
Time Frame
baseline
Title
Walking aid
Description
use of walking aid
Time Frame
baseline
Title
Getting outdoors
Description
If get outdoors by them selves
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 75 years, Living in the central part of Oslo, Norway Living alone in ordinary housing Dependent on home help services for individual care and/or housekeeping activities or home care for medical needs The presence of musculoskeletal pain for three month or longer Ability to walk independently indoors, with or without a walking aid Ability to understand and speak Norwegian Ability to fill in activity diary or to have someone to help them with that. Exclusion Criteria: Older adults ongoing physiotherapy treatment for injury/illness, Are in a palliative stage of treatment Have experienced heart failure in the past three months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid Bergland, Professor
Organizational Affiliation
Oslo Metropolitan University
Official's Role
Study Chair
Facility Information:
Facility Name
Sara Cederbom
City
Oslo
ZIP/Postal Code
0130
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Cederbom, S. (2014). Ability in everyday activities and morale among older women with chronic musculoskeletal pain living alone. A behavioural medicine approach in physiotherapy (Doctoral Thesis), Karolinska Institutet, Stockholm,Sweden
Results Reference
background
PubMed Identifier
12067390
Citation
AGS Panel on Persistent Pain in Older Persons. The management of persistent pain in older persons. J Am Geriatr Soc. 2002 Jun;50(6 Suppl):S205-24. doi: 10.1046/j.1532-5415.50.6s.1.x. No abstract available.
Results Reference
background
PubMed Identifier
26180873
Citation
Global Recommendations on Physical Activity for Health. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK305057/
Results Reference
background
PubMed Identifier
847061
Citation
Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
Results Reference
result
PubMed Identifier
8080219
Citation
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
Results Reference
result
PubMed Identifier
12547051
Citation
Klepstad P, Loge JH, Borchgrevink PC, Mendoza TR, Cleeland CS, Kaasa S. The Norwegian brief pain inventory questionnaire: translation and validation in cancer pain patients. J Pain Symptom Manage. 2002 Nov;24(5):517-25. doi: 10.1016/s0885-3924(02)00526-2.
Results Reference
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PubMed Identifier
10811152
Citation
Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.
Results Reference
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PubMed Identifier
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Citation
Helbostad JL, Taraldsen K, Granbo R, Yardley L, Todd CJ, Sletvold O. Validation of the Falls Efficacy Scale-International in fall-prone older persons. Age Ageing. 2010 Mar;39(2):259. doi: 10.1093/ageing/afp224. Epub 2009 Dec 22. No abstract available.
Results Reference
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PubMed Identifier
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Citation
Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1435-45. doi: 10.1249/mss.0b013e3180616aa2.
Results Reference
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PubMed Identifier
21210901
Citation
Jakobsson U, Westergren A, Lindskov S, Hagell P. Construct validity of the SF-12 in three different samples. J Eval Clin Pract. 2012 Jun;18(3):560-6. doi: 10.1111/j.1365-2753.2010.01623.x. Epub 2011 Jan 6.
Results Reference
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Citation
Frändin K, Grimby G. Assessment of physical activity, fitness and performance in 76-year-olds. Scand J Med Sci Sports. 1994;4(1):41-6.
Results Reference
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PubMed Identifier
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Citation
Utne I, Miaskowski C, Bjordal K, Paul SM, Jakobsen G, Rustoen T. Differences in the use of pain coping strategies between oncology inpatients with mild vs. moderate to severe pain. J Pain Symptom Manage. 2009 Nov;38(5):717-26. doi: 10.1016/j.jpainsymman.2009.03.005. Epub 2009 Sep 22.
Results Reference
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Effect Study of on Intervention on Pain, Function, Health and Behaviour for Older Adults Living With Chronic Pain

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