Free From Pain Study

Liverpool University Hospitals NHS Foundation Trust

Status: Unknown

Conditions: Musculoskeletal Pain; Quality of Life; Fear of Falling

Treatments: Behavioral: Physiotherapy; Behavioral: "Free From Pain Exercise Book"

Study type: Interventional

Funder types: Other

Identifiers

NCT05404399

SP0629

Details and patient eligibility

About

To determine the effectiveness of the "Free From Pain" Exercise Book containing the preformulated 12-week "Free From Pain" exercise programme in reducing pain, improving quality of life and decreasing fear of falling in people over 60 years of age when compared to usual care (referral to physiotherapy).

Full description

According to the World Health Organisation, over 1.5 billion people have musculoskeletal conditions worldwide. Musculoskeletal conditions can cause significant pain, leading to extended periods of immobility and subsequent disability. This causes a loss of fitness, increasing the threat of conditions associated with inactivity, such as cancer and cardiovascular disease. Inactivity will also reduce muscle mass, bringing an increased risk of falls and fall-related injuries. Fortunately, exercise can bring about many health benefits in older age, by improving functional ability and well-being. Additionally, specific programmes which focus on balance and strength reduce the risk and rate of falls. Currently, the most popular rehabilitation modality for seniors is physiotherapy. Unfortunately, there is a huge demand for physiotherapy and there is a waiting period. Waiting for physiotherapy services may have detrimental effects on pain, disability, quality of life, and psychological symptoms in persons with musculoskeletal disorders. A more inexpensive and readily available intervention could therefore be desirable to manage musculoskeletal pain in seniors.

The "Free from Pain" exercise programme, found within the "Free From Pain" exercise book, is a fusion of three different generally accepted exercise 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. Developed by Robertson and Campbell for the New Zealand Accident Compensation Corporation (ACC), the Otago exercise programme aimed to improve balance and strength in patients in order to prevent falls. As a secondary effect, the Otago exercise programme also reduces musculoskeletal pain in community-dwelling older adults. Along with the exercises, the "Free From Pain Exercise Book" also contains 13 chapters. These comprise an introductory chapter, 12 motivation/reason to exercise chapters and 12 exercise-related metaphors.

This is a randomised control trial that will be conducted over a 12-week period. The study population will include 60 participants who will be randomised into a test group and a control group. Participants in the test group (Group 1) will be provided with the "Free From Pain Exercise Book" and participants in the control group (Group 2) would be referred to Physiotherapy (usual care). Participants in the test group (Group 1) will be asked to engage in the 3 sets of exercises within the exercise book for the following 12 weeks. They will be advised to engage in the exercises at least five times a week, whilst reading the informative material once a week. Participants will be asked to provide data in the form of completed surveys at the beginning and the end of the study period.

The aim of the study is to investigate whether the "Free From Pain" exercise Book, containing the preformulated 12-week exercise programme, reduces pain, improves quality of life and decreases fear of falling in people over 60 years of age more than usual care (referral to physiotherapy).

Enrollment: 60 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be at least 60 years of age.
• Have generalised neck, low back and/or musculoskeletal pain.
• Clinical patient not requiring surgical intervention or patient not keen on surgical intervention

Exclusion criteria

• Lacking the physical ability or cardiovascular fitness required to participate in an exercise programme. 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".
• Self-identified lack of mental ability to participate in the exercise programme.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Free From Pain Exercise Book

Experimental group

Description:

Participants in Group 1 will be asked to engage in the 3 sets of exercises within the exercise book for the following 12 weeks. They will be advised to engage in the exercises at least five times a week. The ideal plan would be as follows: Monday - Otago exercises. Tuesday - Neck and Back exercises. Wednesday - Otago exercises. Thursday - Reading the weekly reading material. Friday - Neck and Back exercises. Saturday - Otago exercises. Sunday - Rest day. Furthermore, it will be recommended that participants in Group 1 read one motivation/reason 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 in Group 1 will also be asked to fill in the exercise diary, found at the back of the exercise book, each time they exercise as part of the "Free From Pain" programme.

Treatment:

Behavioral: "Free From Pain Exercise Book"

Usual Care (physiotherapy)

Active Comparator group

Description:

Those in Group 2 (control group) will not be provided with the "Free From Pain Exercise Book", and will instead be referred to physiotherapy as part of standard / usual care. They will be asked to report when their physiotherapy commenced.

Treatment:

Behavioral: Physiotherapy