A Pragmatic Randomised Control Trial Comparing the Efficacy of the "Free From Pain Exercise Book" Versus "The Back Book" in Decreasing Back Pain in Adults Over 60 Years of Age.
Sponsor study identifier
interventional
60
1 country
1
Study Start
January 1, 2023
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Primary Completion
July 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This pragmatic randomised control feasibility trial aims to investigate the effectiveness of the "Free From Pain Exercise Book" in comparison to "The Back Book" for reducing back pain in adults aged 60 and over. The "Free From Pain Exercise Book" contains a 12-week exercise and education programme. The programme is designed to reduce early osteoarthritic and generalised musculoskeletal pain and fear of falling in people over the age of 60. The study will compare the effects of the Free from Pain programme when engaged in independently versus the provision of "The Back Book", which is a booklet that promotes physical activity and a reduction of sedentary behaviour for the purpose of reducing back pain.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 27, 2022
Actual (reported)May 3, 2022
Actual (reported)January 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Oswestry Low Back Pain Disability Questionnaire (OLBPDQ)
Differences in Oswestry Low Back Pain Disability Questionnaire (OLBPDQ) scores to will be assessed to quantify changes in back pain. The OLBPDQ comprises ten questions to assess the severity of back pain, and its effects on personal care, carrying out activities (walking, lifting etc.), sleep quality, social life, travelling and sex-life. Levels of pain/effects of pain will be reported by selecting one statement from five, with the most positive statement denoting a score of 0 and the most negative statement denoting a score of 5.
Baseline, 12 weeks and 6 months
Numerical Pain Rating Scale (NRPS)
Baseline, 12 weeks and 6 months
EuroQol 5-Dimension (EQ-5D)
Baseline, 12 weeks and 6 months
Usefulness scale for patient educational material (USE)
12 weeks and 6 months
Qualatitive questions
12 weeks and 6 months
Compliance to participate in the "Free From Pain" exercises
12 weeks and 6 months
Engagement in exercises following use of "The Back Book"
12 weeks and 6 months
Participants who consent and are randomised into Group 1 (experimental group) will be provided with the "Free From Pain Exercise Book". Participants in Group 1 will be asked to independently engage in the exercises included in the book throughout the entire 6 month study period. They will be advised to either do all 3 sets of exercises 3 times a week or to do the neck and low back exercises twice a week and the Otago exercises 3 times a week. The exercises should take around an hour to complete each day. Furthermore, it will be recommended that participants in this group read one information chapter and one metaphor each week for 12 weeks, to ensure that they absorb the information fully and do not overbear themselves with information.
Participants who consent and are randomised into Group 2 (control group) will be provided with "The Back Book". Participants in Group 2 will be asked to ensure that they read the book in its entirety during the 12-week intervention period and refer to relevant sections during the follow-up period for advice if required.
Contains educational information and exercises to improve musculoskeletal pain and reduce sarcopenia.
Contains advice and guidance on how to deal with and reduce back pain.
Talita Cumi LTD.
Southport, Merseyside, PR8 3NS, United Kingdom
World Health Organisation (WHO) (2021). Musculoskeletal Conditions [Fact Sheet]. [Cited January 2021]. Retrieved from: https://www.who.int/news-room/fact-sheets/detail/musculoskeletal-conditions
Arthritis Research UK. Understanding Arthritis: A Parliamentary Guide to Musculoskeletal Health. Chesterfield: Arthritis Research UK; 2013.
Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000 Jun;13(3):205-17. doi: 10.1097/00002517-200006000-00003.
George Ampat, MBBS, MS, FRCS
Talita Cumi Ltd.
First Submitted
April 27, 2022
First Posted
May 3, 2022
Study Start
January 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 30, 2023
Estimated (date passed)Measurement and Treatment of Back Pain
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Kovacs FM, Abraira V, Zamora J, Fernandez C; Spanish Back Pain Research Network. The transition from acute to subacute and chronic low back pain: a study based on determinants of quality of life and prediction of chronic disability. Spine (Phila Pa 1976). 2005 Aug 1;30(15):1786-92. doi: 10.1097/01.brs.0000172159.47152.dc.
Haas M, Groupp E, Muench J, Kraemer D, Brummel-Smith K, Sharma R, Ganger B, Attwood M, Fairweather A. Chronic disease self-management program for low back pain in the elderly. J Manipulative Physiol Ther. 2005 May;28(4):228-37. doi: 10.1016/j.jmpt.2005.03.010.
Kovacs F, Abraira V, Santos S, Diaz E, Gestoso M, Muriel A, Gil del Real MT, Mufraggi N, Noguera J, Zamora J; Spanish Back Pain Research Network. A comparison of two short education programs for improving low back pain-related disability in the elderly: a cluster randomized controlled trial. Spine (Phila Pa 1976). 2007 May 1;32(10):1053-9. doi: 10.1097/01.brs.0000261556.84266.0f.
Baker MK, Atlantis E, Fiatarone Singh MA. Multi-modal exercise programs for older adults. Age Ageing. 2007 Jul;36(4):375-81. doi: 10.1093/ageing/afm054. Epub 2007 May 30.
Campbell AJ, Robertson MC, Gardner MM, Norton RN, Tilyard MW, Buchner DM. Randomised controlled trial of a general practice programme of home based exercise to prevent falls in elderly women. BMJ. 1997 Oct 25;315(7115):1065-9. doi: 10.1136/bmj.315.7115.1065.
Cederbom S, Arkkukangas M. Impact of the fall prevention Otago Exercise Programme on pain among community-dwelling older adults: a short- and long-term follow-up study. Clin Interv Aging. 2019 Apr 26;14:721-726. doi: 10.2147/CIA.S200188. eCollection 2019.
Bystrom MG, Rasmussen-Barr E, Grooten WJ. Motor control exercises reduces pain and disability in chronic and recurrent low back pain: a meta-analysis. Spine (Phila Pa 1976). 2013 Mar 15;38(6):E350-8. doi: 10.1097/BRS.0b013e31828435fb.
Gross A, Kay TM, Paquin JP, Blanchette S, Lalonde P, Christie T, Dupont G, Graham N, Burnie SJ, Gelley G, Goldsmith CH, Forget M, Hoving JL, Bronfort G, Santaguida PL; Cervical Overview Group. Exercises for mechanical neck disorders. Cochrane Database Syst Rev. 2015 Jan 28;1(1):CD004250. doi: 10.1002/14651858.CD004250.pub5.
Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
Young IA PT, DSc, Dunning J PT, DPT, Butts R PT, PhD, Mourad F PT, DPT, Cleland JA PT, PhD. Reliability, construct validity, and responsiveness of the neck disability index and numeric pain rating scale in patients with mechanical neck pain without upper extremity symptoms. Physiother Theory Pract. 2019 Dec;35(12):1328-1335. doi: 10.1080/09593985.2018.1471763. Epub 2018 Jun 1.
Obradovic M, Lal A, Liedgens H. Validity and responsiveness of EuroQol-5 dimension (EQ-5D) versus Short Form-6 dimension (SF-6D) questionnaire in chronic pain. Health Qual Life Outcomes. 2013 Jul 1;11:110. doi: 10.1186/1477-7525-11-110.
Holzel LP, Ries Z, Dirmaier J, Zill JM, Kriston L, Klesse C, Harter M, Bermejo I. Usefulness scale for patient information material (USE) - development and psychometric properties. BMC Med Inform Decis Mak. 2015 Apr 19;15:34. doi: 10.1186/s12911-015-0153-7.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 21, 2022
Record last verified: 2022-10
At the end of the study, data will be fully anonymised. Only non-identifiable, anonymised data will be archived along with the publication for use of other researchers. For instance, the age, sex, and study results of participants will be archived indefinitely as a supplementary document to the publication.
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