Musculoskeletal PainNCT05404399
Free From Pain Study
A study testing "Free From Pain Exercise Book" and Physiotherapy in people with Musculoskeletal Pain and Quality of Life, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain, Quality of Life, Fear of Falling
- What is being tested?
- "Free From Pain Exercise Book" and Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool University Hospitals Nhs Foundation Trust
Liverpool, Merseyside, L7 8XP
George S Ampat, 07871590593, George.Ampat@liverpoolft.nhs.uk
About this 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.
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).
Read the 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).
- Conditions
- Musculoskeletal Pain, Quality of Life, Fear of Falling
- Being tested
- "Free From Pain Exercise Book", Physiotherapy
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Free From Pain Exercise Book"Behavioural
Participants in Group 1 will be provided with the "Free From Pain Exercise Book".
PhysiotherapyBehavioural
Participants in Group 2 would be referred to Physiotherapy (usual care)
| Study group | Role | What they receive |
|---|---|---|
| Free From Pain Exercise Book | Experimental | 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. Receives: Behavioral: "Free From Pain Exercise Book" |
| Usual Care (physiotherapy) | Active comparator | 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. Receives: Behavioral: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Secondary outcomes (6)
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Length of physiotherapy treatment
Participants in Group 2 will be asked to provide the date when physiotherapy commenced.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404399
- Sponsor's protocol ID
- SP0629
- Status last verified
- Feb 2022
- First submitted
- 27 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05404399
- Acronym / sponsor ID
- SP0629
- Conditions
- Musculoskeletal Pain, Quality of Life, Fear of Falling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free From Pain Exercise Book | Experimental | Behavioral: "Free From Pain Exercise Book"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. |
| Usual Care (physiotherapy) | Active comparator | Behavioral: PhysiotherapyThose 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Free From Pain Exercise Book"Participants in Group 1 will be provided with the "Free From Pain Exercise Book". | Behavioural | Free From Pain Exercise Book |
| PhysiotherapyParticipants in Group 2 would be referred to Physiotherapy (usual care) | Behavioural | Usual Care (physiotherapy) |
Primary outcome
Changes in musculoskeletal health as assessed by the Musculoskeletal Health Questionnaire (MSK-HQ)
Time frame: Baseline and 12 weeks
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.
6 secondary outcomes
Changes in musculoskeletal health as assessed by a Visual Anlogue Scale (VAS)
Time frame: Baseline and 12 weeks
Changes in health-related quality of life as assessed by the EuroQol- 5 Dimension (EQ-5D)
Time frame: Baseline and 12 weeks
Chanes in a fear of falling as assessed by the short Falls Efficacy Scale-International (short FES-I)
Time frame: Baseline and 12 weeks
Participant opinion on the reading mateiral provided as assessed by the Usefulness scale for patient educational material (USE)
Time frame: 12 weeks
Participant compliance to the exercise programme as assessed by an exercise diary
Time frame: 12 weeks
Length of physiotherapy treatment
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Free From Pain Exercise Book" and Physiotherapy in people with Musculoskeletal Pain and Quality of Life, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heather Rogers (01517063702, RGT@RLBUHT.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in musculoskeletal health as assessed by the Musculoskeletal Health Questionnaire (MSK-HQ) (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.