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

NCT02953470 | Unknown DMC

• 1 other identifier: OsloAUCAS2016/859
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  six month

• 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.

  six month

Secondary Outcomes (7)

• Reach of goal setting

  three month

• Pain severity measured by the BPI short version

  six month

• Pain catastrophizing measured by the Catastrophizing subscale

  six month

• Falls efficacy measured by the Norwegian version of the Falls-Efficacy Scale international (FES-I)

  six month

• physical activity level according to a six-point scale

  six month

Other Outcomes (12)

• Consumer questions

  at three and six month

• Age

  baseline

• Gender

  baseline

Study Arms (2)

Individual tailored functional exercise

EXPERIMENTAL

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.

Behavioral: Individual tailored functional exercise

Standard care

ACTIVE COMPARATOR

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.

Behavioral: Standard care

Interventions

Individual tailored functional exercise BEHAVIORAL

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.

Individual tailored functional exercise

Standard care BEHAVIORAL

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.

Standard care

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Oslo Metropolitan University: lead

Study Sites (1)

Sara Cederbom

Oslo, 0130, Norway

Location

Related Publications (12)

• 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

  BACKGROUND

• 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.

  PMID: 12067390 BACKGROUND

• Global Recommendations on Physical Activity for Health. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK305057/

  PMID: 26180873 BACKGROUND

• 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.

  PMID: 847061 RESULT

• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

  PMID: 8080219 RESULT

• 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.

  PMID: 12547051 RESULT

• 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.

  PMID: 10811152 RESULT

• 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.

  PMID: 20031925 RESULT

• 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.

  PMID: 17762378 RESULT

• 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.

  PMID: 21210901 RESULT

• 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.

  RESULT

• 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.

  PMID: 19775862 RESULT

MeSH Terms

Conditions

Chronic Pain; Motor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Astrid Bergland, Professor

  Oslo Metropolitan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: November 2, 2016
• Study Start: October 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: April 19, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)