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

October 20, 2022 updated by: Talita Cumi Ltd.

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: George Ampat, MBBS, MS, FRCS
  • Phone Number: 07871590593
  • Email: geampat@gmail.com

Study Contact Backup

Study Locations

  • United Kingdom
    • Merseyside
      • Southport, Merseyside, United Kingdom, PR8 3NS
        • Talita Cumi LTD.
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Low Back Pain Disability Questionnaire (OLBPDQ)
Time Frame: Baseline, 12 weeks and 6 months
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)
Time Frame: Baseline, 12 weeks and 6 months
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)
Time Frame: Baseline, 12 weeks and 6 months
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)
Time Frame: 12 weeks and 6 months
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
Time Frame: 12 weeks and 6 months
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance to participate in the "Free From Pain" exercises
Time Frame: 12 weeks and 6 months
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
Engagement in exercises following use of "The Back Book"
Time Frame: 12 weeks and 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Talita Cumi Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

July 30, 2023

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

April 27, 2022

First Posted (Actual)

May 3, 2022

Study Record Updates

Last Update Posted (Actual)

October 21, 2022

Last Update Submitted That Met QC Criteria

October 20, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFPETFETS006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Time Frame

The data will become available at the completion of the study on 31/12/2022. It will be available for other researchers indefinitely.

IPD Sharing Access Criteria

The non-identifiable data will be openly available as a supplementary document to the publication.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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