Free From Pain Study
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.
1 other identifier
interventional
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2022
CompletedFirst Posted
Study publicly available on registry
June 3, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJune 3, 2022
February 1, 2022
5 months
May 27, 2022
June 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Changes in musculoskeletal health as assessed by a Visual Anlogue Scale (VAS)
Baseline and 12 weeks
Changes in health-related quality of life as assessed by the EuroQol- 5 Dimension (EQ-5D)
Baseline and 12 weeks
Chanes in a fear of falling as assessed by the short Falls Efficacy Scale-International (short FES-I)
Baseline and 12 weeks
Participant opinion on the reading mateiral provided as assessed by the Usefulness scale for patient educational material (USE)
12 weeks
Participant compliance to the exercise programme as assessed by an exercise diary
12 weeks
- +1 more secondary outcomes
Study Arms (2)
Free From Pain Exercise Book
EXPERIMENTALParticipants 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.
Usual Care (physiotherapy)
ACTIVE COMPARATORThose 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.
Interventions
Participants in Group 1 will be provided with the "Free From Pain Exercise Book".
Participants in Group 2 would be referred to Physiotherapy (usual care)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Liverpool University Hospitals Nhs Foundation Trust
Liverpool, Merseyside, L7 8XP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2022
First Posted
June 3, 2022
Study Start
July 1, 2022
Primary Completion
November 30, 2022
Study Completion
December 31, 2022
Last Updated
June 3, 2022
Record last verified: 2022-02