The "Free From Pain Exercise Book" Versus "The Back Book".
NCT ID: NCT05359107
Last Updated: 2022-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2023-01-01
2023-07-31
Brief Summary
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Detailed Description
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"The Back Book" is a booklet that promotes physical activity and a reduction of sedentary behaviour for the purpose of reducing back pain. One study by Hass et, al. found that the addition of this book to standard treatment improved disability scores significantly. The use of "The Back Book" was further supported by a cluster, randomised control trial which focussed on elderly adults from nursing homes. The study found a significant improvement in disability after one month of being provided with the book. It is known that, in later life, exercise can have many physiological and psychological benefits and can improve functional ability and well-being whilst reducing illness.
The complete "Free From Pain Exercise Book" presents exercises and educational information to improve pain, strength and quality of life in seniors. The "Free from Pain" exercise programme described within the exercise book is a 12-week exercise programme. It is fusion of three different generally accepted exercise programmes. Therapeutic exercise programmes exist for individual body parts, but there is no single generalised exercise programme that targets all body parts. Hence, the creation of this fusion of programmes. The three programmes are the Otago exercises for lower body strength and balance, the motor control exercises for the lower back and the isometric exercises for the neck and shoulder.
The Otago exercise program (OEP) was developed by Robertson and Campbell for the New Zealand accident compensation corporation (ACC). The initial aim of the programme was to improve balance and strength in patients to prevent falls. Further research has shown that the Otago exercise programme is an effective intervention for coping with musculoskeletal pain in community-dwelling older adults. For treating and preventing low back pain, exercise regimes include stretching, strengthening, endurance, aerobic fitness, walking, yoga, Pilates, and motor control exercises. Among these different modalities of exercises for the rehabilitation of low back pain, motor control exercises are one of the most commonly used interventions that have proven to be beneficial. With regards to neck pain, exercise regimes vary from stretching to strengthening exercises. Among the varied regimes, isometric and strengthening exercises of the neck and shoulder are effective modalities for treating neck pain.
Alongside descriptions and images of the exercises described previously, the exercise book also contains 13 chapters. The first chapter acts as an introduction and each of the remaining 12 chapters provide a 'reason to exercise' and an 'exercise-related metaphor'. Each chapter is assigned to a week, from week 1 through to week 12. The reader is encouraged to read one chapter each week over the 12 weeks in the order that they appear in the book.
This pragmatic randomised control feasibility trial will be conducted over 6 months.
60 participants will be split into two even groups of 30 (Group 1 and Group 2). Group 1 (experimental group) will test the use of the "Free From Pain Exercise Book" for reducing back pain and improving quality of life, whilst Group 2 (control group) will test the use of "The Back Book". Each participant will be in the study for a period of six months. As the "Free From Pain" programme is a 12-week exercise programme, the first 12 weeks of the entire six-month study is defined as the intervention period. The subsequent follow-up period, which will run from the 12-week point until the six-month point, is included in the study to allow analysis of long-term participant compliance and to assess the extended effects of both the "Free From Pain Exercise Book" and "The Back Book". Participants will be asked to provide data in the form of completed surveys three times; at baseline, at 12 weeks (once the intervention period is complete) and at six months (at the end of the follow-up period). The study 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. It will compare the effects of the Free from Pain programme when engaged in independently versus the provision of "The Back Book" - a booklet that promotes physical activity and a reduction of sedentary behaviour for the purpose of reducing back pain.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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"The Free From Pain Exercise Book"
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.
"The Free From Pain Exercise Book"
Contains educational information and exercises to improve musculoskeletal pain and reduce sarcopenia.
"The Back Book"
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.
"The Back Book"
Contains advice and guidance on how to deal with and reduce back pain.
Interventions
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"The Free From Pain Exercise Book"
Contains educational information and exercises to improve musculoskeletal pain and reduce sarcopenia.
"The Back Book"
Contains advice and guidance on how to deal with and reduce back pain.
Eligibility Criteria
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Inclusion Criteria
* Has back pain
Exclusion Criteria
* Lack of mental ability to participate in the exercise programme.
* Have had a lower-limb joint (hip or knee) replacement, as some of the exercises may be contra-indicative to these conditions.
* Participants who do not have the adequate skill of the English language - Due to lack of adequate resources and to avoid ethical issues, we will also not be including participants who do not have adequate communication skills in the English language.
60 Years
ALL
Yes
Sponsors
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Talita Cumi Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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George Ampat, MBBS, MS, FRCS
Role: PRINCIPAL_INVESTIGATOR
Talita Cumi Ltd.
Locations
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Talita Cumi LTD.
Southport, Merseyside, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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FFPETFETS006
Identifier Type: -
Identifier Source: org_study_id
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