Quality of Life Clinical Trial
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.
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).
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2022 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Liverpool University Hospitals Nhs Foundation Trust | Liverpool | Merseyside |
Lead Sponsor | Collaborator |
---|---|
Liverpool University Hospitals NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in musculoskeletal health as assessed by the Musculoskeletal Health Questionnaire (MSK-HQ) | The Musculoskeletal Health Questionnaire (MSKHQ), developed by Arthritis Research UK, has been shown to be an easy to understand and relevant survey that is widely used in musculoskeletal health research. For this outcome measure, the minimal clinical difference is a change of 6 points or more in the participant's score. | Baseline and 12 weeks | |
Secondary | Changes in musculoskeletal health as assessed by a Visual Anlogue Scale (VAS) | Improvements in 10-point VAS scale for perceived musculoskeletal pain in the lower back, hips, knees, ankles, and feet, where 0 denotes no pain and 10 denotes extremely severe pain. The Visual Analogue Scale (VAS) is a validated, subjective measure of acute and chronic pain. | Baseline and 12 weeks | |
Secondary | Changes in health-related quality of life as assessed by the EuroQol- 5 Dimension (EQ-5D) | Improvement in EQ-5D. The EuroQol- 5 Dimension (EQ-5D) questionnaire, first developed by the EuroQol Group, evaluates health-related quality of life in a simple survey. | Baseline and 12 weeks | |
Secondary | Chanes in a fear of falling as assessed by the short Falls Efficacy Scale-International (short FES-I) | Improvement in short FES-I. The short Falls Efficacy Scale-International (short FES-I) is a 7-item version of the FES-I. This version has been validated for community-dwelling older population. Furthermore, the short FES-I can predict future falls, muscle weakness, frailty, and overall disability. | Baseline and 12 weeks | |
Secondary | Participant opinion on the reading mateiral provided as assessed by the Usefulness scale for patient educational material (USE) | Usefulness scale for patient educational material (USE) will be used to assess the usefulness of the information provided. | 12 weeks | |
Secondary | Participant compliance to the exercise programme as assessed by an exercise diary | Participant compliance to the exercise programme as assessed using the "Free From Pain" exercise diary for Group 1 participants in order to determine the effects of the programme with relation to intervention acceptance. | 12 weeks | |
Secondary | Length of physiotherapy treatment | Participants in Group 2 will be asked to provide the date when physiotherapy commenced. | 12 weeks |
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