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Free From Pain Study

Primary Purpose

Musculoskeletal Pain, Quality of Life, Fear of Falling

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
"Free From Pain Exercise Book"
Physiotherapy
Sponsored by
Liverpool University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Liverpool University Hospitals Nhs Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Free From Pain Exercise Book

Usual Care (physiotherapy)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Length of physiotherapy treatment
Participants in Group 2 will be asked to provide the date when physiotherapy commenced.

Full Information

First Posted
May 27, 2022
Last Updated
June 1, 2022
Sponsor
Liverpool University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05404399
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool University Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain, Quality of Life, Fear of Falling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Free From Pain Exercise Book
Arm Type
Experimental
Arm 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.
Arm Title
Usual Care (physiotherapy)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
"Free From Pain Exercise Book"
Intervention Description
Participants in Group 1 will be provided with the "Free From Pain Exercise Book".
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy
Intervention Description
Participants in Group 2 would be referred to Physiotherapy (usual care)
Primary Outcome Measure Information:
Title
Changes in musculoskeletal health as assessed by the Musculoskeletal Health Questionnaire (MSK-HQ)
Description
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.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Changes in musculoskeletal health as assessed by a Visual Anlogue Scale (VAS)
Description
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.
Time Frame
Baseline and 12 weeks
Title
Changes in health-related quality of life as assessed by the EuroQol- 5 Dimension (EQ-5D)
Description
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.
Time Frame
Baseline and 12 weeks
Title
Chanes in a fear of falling as assessed by the short Falls Efficacy Scale-International (short FES-I)
Description
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.
Time Frame
Baseline and 12 weeks
Title
Participant opinion on the reading mateiral provided as assessed by the Usefulness scale for patient educational material (USE)
Description
Usefulness scale for patient educational material (USE) will be used to assess the usefulness of the information provided.
Time Frame
12 weeks
Title
Participant compliance to the exercise programme as assessed by an exercise diary
Description
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.
Time Frame
12 weeks
Title
Length of physiotherapy treatment
Description
Participants in Group 2 will be asked to provide the date when physiotherapy commenced.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Rogers
Phone
01517063702
Email
RGT@RLBUHT.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
George Ampat, MBS, FRCS
Phone
07871590593
Email
George.Ampat@liverpoolft.nhs.uk
Facility Information:
Facility Name
Liverpool University Hospitals Nhs Foundation Trust
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George S Ampat
Phone
07871590593
Email
George.Ampat@liverpoolft.nhs.uk

12. IPD Sharing Statement

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Free From Pain Study

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