The Free From Pain Exercise Book Versus The Back Book.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Sarcopenia, Back Pain, Arthritis

Intervention / Treatment
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* Behavioral: The Free From Pain Exercise Book
* Behavioral: The Back Book


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Free From Pain Exercise Book<br>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. | Behavioral: The Free From Pain Exercise Book<br>* Contains educational information and exercises to improve musculoskeletal pain and reduce sarcopenia.<br>|
| Active Comparator: The Back Book<br>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. | Behavioral: The Back Book<br>* Contains advice and guidance on how to deal with and reduce back pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |