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

Chronic Pain Clinical Trial

Official title:

Community-dwelling Older Adults Living With Chronic Musculoskeletal Pain: The Effect of an Evidence-based Intervention on Pain, Function, Health and Behaviour

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02953470
• Other study ID #: OsloAUCAS2016/859
• Status: Active, not recruiting
• Phase: N/A
• First received: October 21, 2016
• Last updated: April 18, 2018
• Start date: October 2016
• Est. completion date: September 2018

Study information

• Verified date: April 2018
• Source: Oslo and Akershus University College of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Individual tailored functional exercise
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.
• Standard care
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.

Locations

Country	Name	City	State
Norway	Sara Cederbom	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo and Akershus University College of Applied Sciences

Country where clinical trial is conducted

Norway, 

References & Publications (12)

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. Review. — View Citation

Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. — View 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

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

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 — View 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. — View 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. — View 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. — View 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 Spor — View Citation

Utne I, Miaskowski C, Bjordal K, Paul SM, Jakobsen G, Rustøen 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.2 — View Citation

World health organization: Organiztion, Global recommendations on physical activity for health.

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Consumer questions	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	at three and six month
Other	Age	Age (years)	baseline
Other	Gender	Gender; male/female	baseline
Other	Home-help services	Number of home help services	baseline
Other	Home care	Number of help from home care	baseline
Other	Medical diagnoses	self-reported number Medical diagnoses	baseline
Other	Pain medication	self-reported Number and use of pain medication	baseline
Other	Years With pain	Number of years With pain	baseline
Other	Falls	Number of falls last year	baseline
Other	Physical activity	If the participants are so physically active as they wish	baseline
Other	Walking aid	use of walking aid	baseline
Other	Getting outdoors	If get outdoors by them selves	baseline
Primary	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
Primary	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	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	three month
Secondary	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.	six month
Secondary	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.	six month
Secondary	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.	six month
Secondary	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.	six month
Secondary	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.	six month
Secondary	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.	three month