Clinical trial NCT02953470: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 105
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Pain-related disability measured with the pain interference score in Brief Pain Inventory (BPI)
timeFrame: six month
measure: Physical function measured by the Norwegian version of the Short Physical Performance Battery
timeFrame: six month
Secondary outcomes:
measure: Reach of goal setting
timeFrame: three month
measure: Pain severity measured by the BPI short version
timeFrame: six month
measure: Pain catastrophizing measured by the Catastrophizing subscale
timeFrame: six month
measure: Falls efficacy measured by the Norwegian version of the Falls-Efficacy Scale international (FES-I)
timeFrame: six month
measure: physical activity level according to a six-point scale
timeFrame: six month
measure: Health related quality of life measured with SF-12
timeFrame: six month
measure: Self-efficacy in relation to goal setting
timeFrame: three month
Other outcomes:
measure: Consumer questions
timeFrame: at three and six month
measure: Age
timeFrame: baseline
measure: Gender
timeFrame: baseline
measure: Home-help services
timeFrame: baseline
measure: Home care
timeFrame: baseline
measure: Medical diagnoses
timeFrame: baseline
measure: Pain medication
timeFrame: baseline
measure: Years With pain
timeFrame: baseline
measure: Falls
timeFrame: baseline
measure: Physical activity
timeFrame: baseline
measure: Walking aid
timeFrame: baseline
measure: Getting outdoors
timeFrame: baseline
Locations:
city: Oslo
country: Norway
facility: Sara Cederbom
Study officials:
affiliation: Oslo Metropolitan University
name: Astrid Bergland, Professor
role: STUDY_CHAIR
References:
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
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.
citation: Global Recommendations on Physical Activity for Health. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK305057/
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.
citation: Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
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.
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.
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.
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.
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.
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.
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.