Chronic PainNCT03152604
Effectiveness of a Pain Management Programme
An observational study of Chronic Pain, run by Teesside University at 2 sites in United Kingdom.
Trial summary
Persistent pain (PP) affects many people worldwide. Patient Education is central to good management. Pain neurophysiology education (PNE) is a new form of education. It aims to help patients 'reconceptualise' their understanding of pain away from the perception that PP is an indicator of tissue damage, to PP is due to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- How many people
- 8 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 28 Jun 2017to 8 Mar 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with persistent musculoskeletal pain of greater than six months duration who have been referred to the pain management programme at James Cook University Hospital.
Who may be able to join
- Have capacity to give informed consent
- 18+ years of age
- Have had pain that has persisted for greater than six months
- Have been referred to the pain management programme at James Cook University Hospital.
Who cannot join
- Pain arising from a non-musculoskeletal origin such as cancer pain, visceral pain or post stroke pain
- Have worsening neural signs
- Anyone being treated by or who has been treated by the researcher (JW)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Teesside University
Middlesbrough, North Yorkshire, TS1 3BX
The Pain Clinic, South Tees Hospitals NHS Foundation Trust
Middlesbrough, North Yorkshire, TS4 3BW
About this study
Official title: The Effectiveness of a Pain Management Programme for Patients With Persistent Pain
Persistent pain (PP) affects many people worldwide. Patient Education is central to good management. Pain neurophysiology education (PNE) is a new form of education. It aims to help patients 'reconceptualise' their understanding of pain away from the perception that PP is an indicator of tissue damage, to PP is due to a sensitised nervous system. This perception is considered a less threatening and more conducive to rehabilitation. There is a growing body of evidence supporting its effectiveness. One unpublished Australian study combined PNE with a pain management program and found significant beneficial effects. However, there is a need to test this intervention rigorously under randomised controlled trial conditions to inform clinical practice. The Medical Research Council state that during the development and evaluation of a complex intervention (in this case a PNE informed PMP), it is important to undertake feasibility work, to investigate the components of randomised controlled trial (RCT) methodology prior to a full scale trial. The overarching aim of this mixed-methods study is to develop a feasible research protocol for a RCT investigating the efficacy of a pain neurophysiology education informed pain management programme. In this feasibility study, participants with PP will be assessed before and after a PNE informed pain management program that they are due to receive as part of their usual care. In the week before the programme participants will attend Teesside University (TU) where they will complete a battery of outcome measures. A subsample of participants will also undergo a semi-structured interview. In the week following completion of their usual care PMP participants will once again attend TU where they will complete the same outcome measures and the same subsample of participants will undergo a second semi-structured interview. At this point participants will have completed the study.
- Conditions
- Chronic Pain
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
The Brief Pain Inventory (Short Form)
Measured: Change from pre intervention (week 0) to post intervention (week 9)
Secondary outcomes (27)
Centre of pressure
Participants will be asked to stand quietly with your gaze at a fixation point, 3m away, at head height. When the participant has settled in double limb stance, arms by their sides they will be asked to instruct the researcher when they are ready. The centre of pressure data will then be recorded for 30 seconds. After the recording the participant will step off the force plate whilst it is re-calibrated giving them approximately one-minute rest before repeating the process so that three trials are recorded in total.
The balance tests will then be repeated in the same way except participants will be instructed to close their eyes.
Measured: Change from pre intervention (week 0) to post intervention (week 9)
Fifty-foot walk at fastest speed
Participants will be required to walk 25 feet, turn around and walk to the starting line as quickly as possible. The time taken will be recorded.
Measured: Change from pre intervention (week 0) to post intervention (week 9)
Repeated sit-to-stand
Participants will be required to sit-to-stand from a standard chair 5 times as quickly as possible. The time taken will be recorded. This will be repeated a further time and the average time take for the two trials used for analysis to enhance reliability (Simmonds et al., 1998).
Measured: Change from pre intervention (week 0) to post intervention (week 9)
The Pain Catastrophising Scale
Measured: Change from pre intervention (week 0) to post intervention (week 9)
Neurophysiology of Pain Questionnaire
Measured: Change from pre intervention (week 0) to post intervention (week 9)
EQ-5D-5L
Measured: Change from pre intervention (week 0) to post intervention (week 9)
EQ-VAS
Measured: Change from pre intervention (week 0) to post intervention (week 9)
The Tampa Scale of Kinesiophobia
Measured: Change from pre intervention (week 0) to post intervention (week 9)
Pain Self-Efficacy Questionnaire
Measured: Change from pre intervention (week 0) to post intervention (week 9)
CORE-10
Measured: Collected at the start of every session of the 8 session pain management programme which runs over 9 weeks
Stride Length
It is measured on the line of progression between the heel points of two consecutive footprints of the same foot (left to left, right to right).
Measured: Change from pre intervention (week 0) to post intervention (week 9)
Step Length
It is measured along the length of the walkway, from the heel center of the current footprint to the heel center of the previous footprint on the opposite foot.
Measured: Change from pre intervention (week 0) to post intervention (week 9)
H-H Base of Support or Base Width
It is the vertical distance from heel center of one footprint to the line of progression formed by two footprints of the opposite foot.
Measured: Change from pre intervention (week 0) to post intervention (week 9)
Toe In / Toe Out
It is the angle between the line of progression and the midline of the footprint. In Figure 7, theta is the angle between the mid-line of the right footprint and the line of progression. Angle theta is zero if the geometric mid- line of the footprint is parallel to the line of progression; positive, toe-out, when the mid-line of the footprint is outside the line of progression and negative, toe-in, when inside the line of progression. The unit of measure is degrees.
Measured: Change from pre intervention (week 0) to post intervention (week 9)
Step Width
It is measured from the midline midpoint of the current footprint to the midline midpoint of the previous footprint on the opposite foot.
Measured: Change from pre intervention (week 0) to post intervention (week 9)
Stride width
It is the vertical distance from midline midpoint of one footprint to the line formed by midline midpoints of two footprints of the opposite foot.
Measured: Change from pre intervention (week 0) to post intervention (week 9)
Step Time
It is the time elapsed from first contact of one foot to first contact of the opposite foot. It is measured in seconds (sec).
Measured: Change from pre intervention (week 0) to post intervention (week 9)
Stride Time
It is the time elapsed between the first contacts of two consecutive footfalls of the same foot. It is measured in seconds (sec).
Measured: Change from pre intervention (week 0) to post intervention (week 9)
Single Support
It is the time elapsed between the Last Contact of the current footfall to the First Contact of the next footfall of the same foot.
Measured: Change from pre intervention (week 0) to post intervention (week 9)
% Single Support
It is the % time elapsed between the Last Contact of the current footfall to the First Contact of the next footfall of the same foot.
Measured: Change from pre intervention (week 0) to post intervention (week 9)
Total Double Support
The two periods when both feet are on the floor, are called initial double support and terminal double support. Initial double support occurs from heel contact of one footfall to toe-off of the opposite footfall. Terminal double support occurs from opposite footfall heel strike to support footfall toe-off. Total double support is the sum of the initial double support added to the terminal double support. It is measured in seconds (sec).
Measured: Change from pre intervention (week 0) to post intervention (week 9)
%Total Double Support
The two periods when both feet are on the floor, are called initial double support and terminal double support. Initial double support occurs from heel contact of one footfall to toe-off of the opposite footfall. Terminal double support occurs from opposite footfall heel strike to support footfall toe-off. Total double support is the sum of the initial double support added to the terminal double support. It is measured in seconds (sec) and expressed as a percent of the Gait Cycle time for the same foot.
Measured: Change from pre intervention (week 0) to post intervention (week 9)
Stance Time
The stance phase is the weight bearing portion of each gait cycle. It is initiated by heel contact and ends with toe off of the same foot. It is the time elapsed between the First Contact and the Last Contact of two consecutive footfalls on the same foot. It is also presented as a percentage of the Gait Cycle time.
Measured: Change from pre intervention (week 0) to post intervention (week 9)
% Stance Time
The stance phase is the weight bearing portion of each gait cycle. It is initiated by heel contact and ends with toe off of the same foot. It is the time elapsed between the First Contact and the Last Contact of two consecutive footfalls on the same foot. It is presented as a percentage of the Gait Cycle time.
Measured: Change from pre intervention (week 0) to post intervention (week 9)
Swing Time
It is initiated with toe off and ends with heel strike. It is the time elapsed between the Last Contact of the current footfall to the First Contact of the next footfall on the same foot. It is expressed in seconds (sec). The Swing Time is equal to the Single Support time of the opposite foot.
Measured: Change from pre intervention (week 0) to post intervention (week 9)
%Swing Time
It is initiated with toe off and ends with heel strike. It is the time elapsed between the Last Contact of the current footfall to the First Contact of the next footfall on the same foot. It is expressed in seconds (sec) and it is presented as a percent of the Gait Cycle of the same foot. The Swing Time is equal to the Single Support time of the opposite foot.
Measured: Change from pre intervention (week 0) to post intervention (week 9)
Comfortable walking velocity
Measured: Change from pre intervention (week 0) to post intervention (week 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start28 Jun 2017
- Primary completion8 Mar 2019 (estimated)
- Study completion8 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Collaborators
- South Tees Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, James Watson, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152604
- Sponsor's protocol ID
- 177/16
- Status last verified
- Oct 2018
- First submitted
- 3 May 2017
- Last updated
- 26 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Pain Management Programme for Patients With Persistent Pain
- ClinicalTrials.gov ID
- NCT03152604
- Acronym / sponsor ID
- 177/16
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Collaborators
- South Tees Hospitals NHS Foundation Trust
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 8 Mar 2019 (estimated)
- Study completion
- 8 Mar 2019 (estimated)
- First posted
- 15 May 2017 (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.
Persistent pain (PP) affects many people worldwide. Patient Education is central to good management. Pain neurophysiology education (PNE) is a new form of education. It aims to help patients 'reconceptualise' their understanding of pain away from the perception that PP is an indicator of tissue damage, to PP is due to a sensitised nervous system. This perception is considered a less threatening and more conducive to rehabilitation. There is a growing body of evidence supporting its effectiveness. One unpublished Australian study combined PNE with a pain management program and found significant beneficial effects. However, there is a need to test this intervention rigorously under randomised controlled trial conditions to inform clinical practice. The Medical Research Council state that during the development and evaluation of a complex intervention (in this case a PNE informed PMP), it is important to undertake feasibility work, to investigate the components of randomised controlled trial (RCT) methodology prior to a full scale trial. The overarching aim of this mixed-methods study is to develop a feasible research protocol for a RCT investigating the efficacy of a pain neurophysiology education informed pain management programme. In this feasibility study, participants with PP will be assessed before and after a PNE informed pain management program that they are due to receive as part of their usual care. In the week before the programme participants will attend Teesside University (TU) where they will complete a battery of outcome measures. A subsample of participants will also undergo a semi-structured interview. In the week following completion of their usual care PMP participants will once again attend TU where they will complete the same outcome measures and the same subsample of participants will undergo a second semi-structured interview. At this point participants will have completed the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with persistent musculoskeletal pain of greater than six months duration who have been referred to the pain management programme at James Cook University Hospital.
Key inclusion criteria (4 listed)
- Have capacity to give informed consent
- 18+ years of age
- Have had pain that has persisted for greater than six months
- Have been referred to the pain management programme at James Cook University Hospital.
Key exclusion criteria (3 listed)
- Pain arising from a non-musculoskeletal origin such as cancer pain, visceral pain or post stroke pain
- Have worsening neural signs
- Anyone being treated by or who has been treated by the researcher (JW)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Brief Pain Inventory (Short Form)
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
27 secondary outcomes
Centre of pressure
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
Fifty-foot walk at fastest speed
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
Repeated sit-to-stand
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
The Pain Catastrophising Scale
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
Neurophysiology of Pain Questionnaire
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
EQ-5D-5L
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
EQ-VAS
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
The Tampa Scale of Kinesiophobia
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
Pain Self-Efficacy Questionnaire
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
CORE-10
Time frame: Collected at the start of every session of the 8 session pain management programme which runs over 9 weeks
Stride Length
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
Step Length
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
H-H Base of Support or Base Width
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
Toe In / Toe Out
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
Step Width
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
Stride width
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
Step Time
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
Stride Time
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
Single Support
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
% Single Support
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
Total Double Support
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
%Total Double Support
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
Stance Time
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
% Stance Time
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
Swing Time
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
%Swing Time
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
Comfortable walking velocity
Time frame: Change from pre intervention (week 0) to post intervention (week 9)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Teesside University at 2 sites 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 4 inclusion and 3 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 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Brief Pain Inventory (Short Form) (time frame: Change from pre intervention (week 0) to post intervention (week 9)). 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 26 Oct 2018; AzTrials last refreshed its copy on 28 Oct 2026.