The "Free From Pain Exercise Book" Versus "The Back Book".

Sarcopenia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05359107
• Other study ID #: FFPETFETS006
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: October 2022
• Source: Talita Cumi Ltd.
• Contact: George Ampat, MBBS, MS, FRCS
• Phone: 07871590593
• Email: geampat[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Chronic musculoskeletal conditions are the leading cause of disability worldwide. The World Health Organization estimates that approximately 1.71 billion people have musculoskeletal conditions globally. They cause a significant economic burden on the NHS, with £5 billion of England's yearly NHS budget going towards the treatment of musculoskeletal conditions. The most reported musculoskeletal ailment throughout the world is back pain, for which the lifetime prevalence has been reported to be as high as 84%. Back pain can affect individuals of all ages, but has a particularly negative effect on elderly people, causing difficulty in daily living tasks for those over 65 years old. Difficulty in completing everyday tasks can result in immobility, causing a loss of muscle mass and fitness, an increased risk of falls, further injury, and diseases associated with inactivity or sedentary behaviours (such as heart attack and some cancers).

"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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 31, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• > 60 years of age

• Has back pain

Exclusion Criteria:

• Lacking the physical ability or cardiovascular fitness required to participate in the "Free From Pain" exercises. This criterion will be explained on the participant information sheet by stating, "If you are unable to walk up a flight of stairs without getting breathless, please do not apply for participation in this study". This will also be confirmed in the initial consultation, during which Dr. Ampat will once again ask participants this question.

• 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.

Related Conditions & MeSH terms

• Arthritis
• Back Pain
• Sarcopenia

Intervention

Behavioral:
• "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.

Locations

Country	Name	City	State
United Kingdom	Talita Cumi LTD.	Southport	Merseyside

Sponsors (1)

Lead Sponsor	Collaborator
Talita Cumi Ltd.

Country where clinical trial is conducted

United Kingdom, 

References & Publications (15)

Arthritis Research UK. Understanding Arthritis: A Parliamentary Guide to Musculoskeletal Health. Chesterfield: Arthritis Research UK; 2013.

Baker MK, Atlantis E, Fiatarone Singh MA. Multi-modal exercise programs for older adults. Age Ageing. 2007 Jul;36(4):375-81. Epub 2007 May 30. Review. — View Citation

Byström 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. — View Citation

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. — View Citation

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. — View Citation

Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. Review. — View Citation

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, Brønfort G, Santaguida PL; Cervical Overview Group. Exercises for mechanical neck disorders. Cochrane Database Sys — View Citation

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. — View Citation

Hölzel LP, Ries Z, Dirmaier J, Zill JM, Kriston L, Klesse C, Härter 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- — View Citation

Kovacs F, Abraira V, Santos S, Díaz 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 — View Citation

Kovacs FM, Abraira V, Zamora J, Fernández 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). — View Citation

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. Review. — View Citation

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. Review. — View Citation

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

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 — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance to participate in the "Free From Pain" exercises	Participants in Group 1 will be required to fill in the exercise diary found at the back of the "Free From Pain Exercise Book" each time they engage in the "Free From Pain" exercises during the initial 12-week intervention period. To assess long-term compliance, they will be required to populate this second diary every time they engage in the "Free From Pain" exercises during the follow-up period.	12 weeks and 6 months
Other	Engagement in exercises following use of "The Back Book"	During a phone call at 12 weeks and six months, participants in Group 2 will be asked to report how much they exercised (if at all) during the intervention and follow-up periods respectively, and what this physical activity involved.	12 weeks and 6 months
Primary	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
Secondary	Numerical Pain Rating Scale (NRPS)	Differences in 11-point Numerical Pain Rating Scale (NPRS) scores to determine changes in back pain. Participants will be required to rate their back pain on this scale, where 0 denotes 'no pain at all' and 10 denotes the 'worst possible pain'.	Baseline, 12 weeks and 6 months
Secondary	EuroQol 5-Dimension (EQ-5D)	Differences in EuroQol 5-Dimension (EQ-5D) Questionnaire scores to observe alterations in health-related quality of life	Baseline, 12 weeks and 6 months
Secondary	Usefulness scale for patient educational material (USE)	Usefulness scale for patient educational material (USE) to evaluate the usefulness of the reading material provided ("Free From Pain Exercise Book" / "The Back Book"). A maximum total score of 90 suggests that the participant 'completely agrees' with nine positive statements regarding the usefullness of the information material provided, whilst a minimum score of 0 suggests that they 'completely disagree' with said statements.	12 weeks and 6 months
Secondary	Qualatitive questions	Qualitative questions to assess participant opinions regarding the "Free From Pain Exercise Book" and "The Back Book". Questions will include 'What did you like about the "Free From Pain Exercise Book" / "The Back Book?"' and 'How do you think the "Free From Pain Exercise Book" / "The Back Book" could be improved?'.	12 weeks and 6 months