Clinical trial NCT05404399: Free From Pain Study
Official title: A Randomised Control Trial Evaluating the Use of a Combined Preformulated Exercise Plan in the Improvement of Musculoskeletal Health in Patients With Generalised Neck and Low Back Pain.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Musculoskeletal Pain
Quality of Life
Fear of Falling
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2022-06-03
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in musculoskeletal health as assessed by the Musculoskeletal Health Questionnaire (MSK-HQ)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Changes in musculoskeletal health as assessed by a Visual Anlogue Scale (VAS)
timeFrame: Baseline and 12 weeks
measure: Changes in health-related quality of life as assessed by the EuroQol- 5 Dimension (EQ-5D)
timeFrame: Baseline and 12 weeks
measure: Chanes in a fear of falling as assessed by the short Falls Efficacy Scale-International (short FES-I)
timeFrame: Baseline and 12 weeks
measure: Participant opinion on the reading mateiral provided as assessed by the Usefulness scale for patient educational material (USE)
timeFrame: 12 weeks
measure: Participant compliance to the exercise programme as assessed by an exercise diary
timeFrame: 12 weeks
measure: Length of physiotherapy treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals Nhs Foundation Trust
state: Merseyside
Study officials:
References: