Chronic PainNCT02953470
Effect Study of on Intervention on Pain, Function, Health and Behaviour for Older Adults Living With Chronic Pain
A study testing Individual tailored functional exercise in people with Chronic Pain, run by Oslo Metropolitan University at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Individual tailored functional exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Older adults ongoing physiotherapy treatment for injury/illness, Are in a palliative stage of treatment Have experienced heart failure in the past three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community-dwelling Older Adults Living With Chronic Musculoskeletal Pain: The Effect of an Evidence-based Intervention on Pain, Function, Health and Behaviour
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Individual tailored functional exercise, Standard care
- 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
- Medical subject headings
- Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual tailored functional exerciseBehavioural
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 careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: six month
Secondary outcomes (7)
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
Measured: three month
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.
Measured: six month
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.
Measured: six month
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.
Measured: six month
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.
Measured: six month
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.
Measured: six month
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.
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Astrid Bergland, Professor, Study chair, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953470
- Sponsor's protocol ID
- OsloAUCAS2016/859
- Status last verified
- Apr 2018
- First submitted
- 21 Oct 2016
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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
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.
PubMed 12067390Global Recommendations on Physical Activity for Health. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK305057/
PubMed 26180873Bandura 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.
PubMed 847061Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
PubMed 8080219Klepstad 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.
PubMed 12547051Guralnik 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.
PubMed 10811152Helbostad 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.
PubMed 20031925Nelson 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.
PubMed 17762378Jakobsson 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.
PubMed 21210901Frändin K, Grimby G. Assessment of physical activity, fitness and performance in 76-year-olds. Scand J Med Sci Sports. 1994;4(1):41-6.
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.
PubMed 19775862
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-dwelling Older Adults Living With Chronic Musculoskeletal Pain: The Effect of an Evidence-based Intervention on Pain, Function, Health and Behaviour
- ClinicalTrials.gov ID
- NCT02953470
- Acronym / sponsor ID
- OsloAUCAS2016/859
- Conditions
- Chronic Pain
- Keywords
- chronic pain, community-dwelling, older adults, physical activity, physiotherapy, behavioural medicine, biopsychosocial, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual tailored functional exercise | Experimental | Behavioral: Individual tailored functional exerciseReceives 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. |
| Standard care | Active comparator | Behavioral: Standard careThe 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Older adults ongoing physiotherapy treatment for injury/illness, Are in a palliative stage of treatment Have experienced heart failure in the past three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual tailored functional exerciseReceive 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. | Behavioural | Individual tailored functional exercise |
| Standard careReceives 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. | Behavioural | Standard care |
Primary outcome
Pain-related disability measured with the pain interference score in Brief Pain Inventory (BPI)
Time frame: six month
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
Time frame: six month
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.
7 secondary outcomes
Reach of goal setting
Time frame: three month
Pain severity measured by the BPI short version
Time frame: six month
Pain catastrophizing measured by the Catastrophizing subscale
Time frame: six month
Falls efficacy measured by the Norwegian version of the Falls-Efficacy Scale international (FES-I)
Time frame: six month
physical activity level according to a six-point scale
Time frame: six month
Health related quality of life measured with SF-12
Time frame: six month
Self-efficacy in relation to goal setting
Time frame: three month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- BackgroundCederbom, 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: PubMed 12067390AGS 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.
- Background: PubMed 26180873Global Recommendations on Physical Activity for Health. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK305057/
- Results publication: PubMed 847061Bandura 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 publication: PubMed 8080219Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Results publication: PubMed 12547051Klepstad 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 publication: PubMed 10811152Guralnik 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 publication: PubMed 20031925Helbostad 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 publication: PubMed 17762378Nelson 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 publication: PubMed 21210901Jakobsson 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 publicationFrändin 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 publication: PubMed 19775862Utne 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astrid Bergland, Professor study chair
Oslo Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual tailored functional exercise in people with Chronic Pain, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-related disability measured with the pain interference score in Brief Pain Inventory (BPI) (time frame: six month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02953470, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.