Chronic Musculoskeletal PainNCT06175884
Effectiveness of Physiotherapist's Communication Skills on Clinical Outcomes in Chronic Musculoskeletal Patients
A study testing Video about pain neuroscience education with enhancing communication skills and Video about pain neuroscience education without enhancing communication skills in people with Chronic Musculoskeletal Pain, run by University of Thessaly at 1 site in Greece.
Trial summary
The purpose of this study is to investigate the impact of the physiotherapist's communication on the clinical presentation of patients with chronic musculoskeletal pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Musculoskeletal Pain
- What is being tested?
- Video about pain neuroscience education with enhancing communication skills and Video about pain neuroscience education without enhancing communication skills
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteGreece
- Study dates
- 15 Jan 2024to 30 Mar 2025
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants should speak and understand the Greek language, as the questionnaires and the video will be in Greek
- Participants should experience pain in one of the following four different areas: cervical or lumbar spine, knee, or shoulder
- Pain of musculoskeletal origin
- Pain lasting more than 3 months, evident on most days of the week to be classified as chronic pain, with a pain intensity of at least 3/10 Numeric Pain Rating Scale.
Who cannot join
- Medication for neurological/psychiatric disorders
- Pain medication on the day agreed upon with the researcher, in order to minimize the potential influence of medication
- Undergoing surgery in the last six months
- Pregnancy or childbirth before 1 year
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University of Thessaly
Lamia, 35132
Eleni Kapreli, PhD, ekapreli@uth.gr
Konstantina Savvoulidou, MSc, ksavvoulidou@uth.gr
About this study
Official title: Effectiveness of Physiotherapist's Communication Skills on Clinical Outcomes in Patients With Chronic Musculoskeletal Pain: A Randomized Controlled Trial
The purpose of this study is to investigate the impact of the physiotherapist's communication on the clinical presentation of patients with chronic musculoskeletal pain.
Read the detailed description
The purpose of this study is to investigate the impact of the physiotherapist's communication on the clinical presentation of patients with chronic musculoskeletal pain. Sixty-nine (69) patients with chronic musculoskeletal pain in the cervical or lumbar spine, knee, or shoulder will participate. They will be randomly divided into three groups, each consisting of thirty-three (33) patients. One group (Experimental- Good communication skills) will watch the video in which physiotherapist will develop qualities of good communication while he explains about chronic musculoskeletal pain, the other group (Experimental- Poor communication skills ) will view the video in which the physiotherapist imparts information and explains chronic pain without enhancing his communication skills and lastly, the control group (control) that will not view any video.
- Conditions
- Chronic Musculoskeletal Pain
- Being tested
- Video about pain neuroscience education with enhancing communication skills, Video about pain neuroscience education without enhancing communication skills
- Keywords
- communication skills, chronic musculoskeletal pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video about pain neuroscience education with enhancing communication skillsOther
Participants will watch a brief video on pain neuroscience in which physiotherapist will show evidence-based communication skills to effectively convey information to patients.
Video about pain neuroscience education without enhancing communication skillsOther
Participants will watch a brief video on pain neuroscience in which physiotherapist will not show evidence-based communication skills to effectively convey information to patients.
| Study group | Role | What they receive |
|---|---|---|
| Good communication skills | Experimental | Participants will watch a video about the pain neuroscience education in which physiotherapist will develop qualities of good communication while he will be giving information and explanation about chronic musculoskeletal pain. Receives: Other: Video about pain neuroscience education with enhancing communication skills |
| Poor communication skills | Experimental | Participants will watch a video about the pain neuroscience education in which physiotherapist will not develop qualities of good communication while he will be giving information and explanation about chronic musculoskeletal pain. Receives: Other: Video about pain neuroscience education without enhancing communication skills |
| Control | No intervention | Participants will not watch any video |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS: Numeric Pain Rating Scale
The Numeric Pain Rating Scale will be utilized to evaluate the severity of pain. Participants will provide a score ranging from 0 (indicating no pain) to 10 (representing the most intense pain they have ever felt).
Measured: Changes from baseline to10 minutes after watching the video
PPT: Pressure Pain Threshold
The Pain Pressure Threshold (PPT) is a method utilized to quantify the sensitivity of deep muscular tissues. In this measurement, an algometer is commonly employed to apply pressure to a specific area, and the point at which a gradually increasing pressure becomes painful is noted. In the context of PPT, lower values are indicative of heightened sensitivity, suggesting that the individual experiences pain at a lower pressure threshold. Therefore, lower PPT values are interpreted as an indication of increased sensitivity in the deep muscular tissues.
Measured: Changes from baseline to10 minutes after watching the video
Secondary outcomes (9)
Pain Distribution
The Pain Distribution App (PDA) will be employed to document the location of pain. This self-reported tool is designed to evaluate the distribution and extent of pain across different areas of the body. The reliability of the PDA has been previously demonstrated.
Measured: Changes from baseline to10 minutes after watching the video
CSI: Central Sensitisation Inventory
The Central Sensitisation Inventory (CSI) serves as a self-report tool aimed at identifying individuals with symptoms potentially linked to Central Sensitisation. The inventory consists of two parts. Part A involves 25 questions related to common Central Sensitisation Syndrome (CSS) symptoms. Patients rate each question on a scale from 0 (never) to 4 (always). A total score exceeding 40 suggests the presence of central sensitisation. In Part B, patients indicate if they have received a diagnosis for specific CSS disorders or related conditions, such as anxiety and depression. Notably, only the scores from Part A are considered in the assessment.
Measured: Baseline
BIPQ: Brief Illness Perception Questionnaire
The Brief Illness Perception Questionnaire (B-IPQ) functions as an assessment tool for examining cognitive and emotional perceptions of illness. Comprising eight items, this questionnaire evaluates cognitive illness representation, emotional illness representation, and illness comprehensibility representation. Scoring involves rating each item on a scale from 0 to 10, where higher scores signify a more threatening perception of the illness. The total B-IPQ score is obtained by summing the scores of all eight items, resulting in a potential range of 0 to 80. Elevated scores on this scale indicate a more negative or distressing perception of the illness.
Measured: Changes from baseline to 10 minutes after watching the video
PCS: Pain Catastrophizing Scale
The 13-item scale is structured around three dimensions: rumination over pain, magnification of pain, and helplessness in the face of pain symptoms. Both the total score and subscale scores for the Pain Catastrophizing Scale (PCS) are calculated by adding up the ratings for each item. In this study, the focus is on the total score, which ranges from 0 to 52, with higher scores indicating a higher level of pain catastrophizing.
Measured: Changes from baseline to 10 minutes after watching the video
STAI-40: State - Trait Anxiety Inventory
The State-Trait Anxiety Inventory (STAI) is a psychological assessment tool comprising 40 self-report items, rated on a 4-point Likert scale. This inventory is designed to gauge two distinct forms of anxiety: state anxiety and trait anxiety. Elevated scores on the STAI are positively associated with increased levels of anxiety.
Measured: Changes from baseline to 10 minutes after watching the video
TSK: Tampa Scale for Kinesiophobia
This questionnaire serves as a tool for assessing the fear of movement or the fear of (re)injury in individuals experiencing pain. The resulting score can range from a minimum of 11 to a maximum of 44 points, with a higher score indicating a greater degree of kinesiophobia. A score of ≥18 is considered indicative of a fear of movement, and the severity of this fear escalates with higher scores.
Measured: Changes from baseline to 10 minutes after watching the video
VES: Video Engagement Scale
Video Engagement was evaluated using the Video Engagement Scale (VES-sf). This questionnaire, designed to measure participants' engagement while watching a video, consists of eight items rated on a scale from 0 ('totally disagree') to 7 ('totally agree'). Scores on the VES-sf range from 0 to 56, with higher scores indicating greater engagement during video viewing. To determine participant inclusion or exclusion, the specific item 'I was fully concentrated on the video while watching' was utilized. Participants with a score lower than 3 on this item were excluded from the study.
Measured: Changes from baseline to 10 minutes after watching the video
Working Alliance Inventory - Short Revised (WAI-SR)
The measurement of bonding in the context of patient-physiotherapist interactions is conducted using the Bonding scale of the Working Alliance Inventory - Short Revised (WAI-SR). Bonding, a crucial component of the working alliance, is defined as the collaborative, warm, and supportive connection between a patient and a therapist. The WAI-SR bond scale assesses the quality of this bond and comprises four items, each rated on a scale from 1 ('never') to 5 ('always'). Scores on the bond scale range from 4 to 20, with higher scores indicative of a higher perceived quality in the bond between the patient and the therapist.
Measured: Changes from baseline to 10 minutes after watching the video
Global Rating of Change Scales
The Global Rating of Change (GRoC) is a scale designed to evaluate the extent to which a patient's condition has improved, worsened, or remained stable, usually after receiving treatment. The GRoC typically involves a single question that prompts the patient to rate the change in their specific condition over a defined time frame. The GRoC is an 11-point scale, ranging from -5 (indicating a significant deterioration or being "very much worse") to 0 (representing no change or "unchanged") and up to +5 (indicating complete recovery or being "completely recovered").
Measured: Changes from baseline to 10 minutes after watching the video
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start15 Jan 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantina Savvoulidou, University of Thessaly
- Investigators
- Eleni Kapreli, Study chair, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175884
- Sponsor's protocol ID
- 10
- Status last verified
- Oct 2024
- First submitted
- 27 Nov 2023
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physiotherapist's Communication Skills on Clinical Outcomes in Patients With Chronic Musculoskeletal Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06175884
- Acronym / sponsor ID
- 10
- Conditions
- Chronic Musculoskeletal Pain
- Keywords
- communication skills, chronic musculoskeletal pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 19 Dec 2023 (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.
The purpose of this study is to investigate the impact of the physiotherapist's communication on the clinical presentation of patients with chronic musculoskeletal pain.
Detailed description
The purpose of this study is to investigate the impact of the physiotherapist's communication on the clinical presentation of patients with chronic musculoskeletal pain. Sixty-nine (69) patients with chronic musculoskeletal pain in the cervical or lumbar spine, knee, or shoulder will participate. They will be randomly divided into three groups, each consisting of thirty-three (33) patients. One group (Experimental- Good communication skills) will watch the video in which physiotherapist will develop qualities of good communication while he explains about chronic musculoskeletal pain, the other group (Experimental- Poor communication skills ) will view the video in which the physiotherapist imparts information and explains chronic pain without enhancing his communication skills and lastly, the control group (control) that will not view any video.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Good communication skills | Experimental | Other: Video about pain neuroscience education with enhancing communication skillsParticipants will watch a video about the pain neuroscience education in which physiotherapist will develop qualities of good communication while he will be giving information and explanation about chronic musculoskeletal pain. |
| Poor communication skills | Experimental | Other: Video about pain neuroscience education without enhancing communication skillsParticipants will watch a video about the pain neuroscience education in which physiotherapist will not develop qualities of good communication while he will be giving information and explanation about chronic musculoskeletal pain. |
| Control | No intervention | –Participants will not watch any video |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants should speak and understand the Greek language, as the questionnaires and the video will be in Greek
- Participants should experience pain in one of the following four different areas: cervical or lumbar spine, knee, or shoulder
- Pain of musculoskeletal origin
- Pain lasting more than 3 months, evident on most days of the week to be classified as chronic pain, with a pain intensity of at least 3/10 Numeric Pain Rating Scale.
Key exclusion criteria (4 listed)
- Medication for neurological/psychiatric disorders
- Pain medication on the day agreed upon with the researcher, in order to minimize the potential influence of medication
- Undergoing surgery in the last six months
- Pregnancy or childbirth before 1 year
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 |
|---|---|---|
| Video about pain neuroscience education with enhancing communication skillsParticipants will watch a brief video on pain neuroscience in which physiotherapist will show evidence-based communication skills to effectively convey information to patients. | Other | Good communication skills |
| Video about pain neuroscience education without enhancing communication skillsParticipants will watch a brief video on pain neuroscience in which physiotherapist will not show evidence-based communication skills to effectively convey information to patients. | Other | Poor communication skills |
Primary outcome
NPRS: Numeric Pain Rating Scale
Time frame: Changes from baseline to10 minutes after watching the video
The Numeric Pain Rating Scale will be utilized to evaluate the severity of pain. Participants will provide a score ranging from 0 (indicating no pain) to 10 (representing the most intense pain they have ever felt).
PPT: Pressure Pain Threshold
Time frame: Changes from baseline to10 minutes after watching the video
The Pain Pressure Threshold (PPT) is a method utilized to quantify the sensitivity of deep muscular tissues. In this measurement, an algometer is commonly employed to apply pressure to a specific area, and the point at which a gradually increasing pressure becomes painful is noted. In the context of PPT, lower values are indicative of heightened sensitivity, suggesting that the individual experiences pain at a lower pressure threshold. Therefore, lower PPT values are interpreted as an indication of increased sensitivity in the deep muscular tissues.
9 secondary outcomes
Pain Distribution
Time frame: Changes from baseline to10 minutes after watching the video
CSI: Central Sensitisation Inventory
Time frame: Baseline
BIPQ: Brief Illness Perception Questionnaire
Time frame: Changes from baseline to 10 minutes after watching the video
PCS: Pain Catastrophizing Scale
Time frame: Changes from baseline to 10 minutes after watching the video
STAI-40: State - Trait Anxiety Inventory
Time frame: Changes from baseline to 10 minutes after watching the video
TSK: Tampa Scale for Kinesiophobia
Time frame: Changes from baseline to 10 minutes after watching the video
VES: Video Engagement Scale
Time frame: Changes from baseline to 10 minutes after watching the video
Working Alliance Inventory - Short Revised (WAI-SR)
Time frame: Changes from baseline to 10 minutes after watching the video
Global Rating of Change Scales
Time frame: Changes from baseline to 10 minutes after watching the video
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Eleni Kapreli study chair
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video about pain neuroscience education with enhancing communication skills and Video about pain neuroscience education without enhancing communication skills in people with Chronic Musculoskeletal Pain, run by University of Thessaly at 1 site in Greece.
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 4 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 23 Oct 2024. 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 Greece. 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 Konstantina Savvoulidou (+30 223 106 0235, ksavvoulidou@uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPRS: Numeric Pain Rating Scale (time frame: Changes from baseline to10 minutes after watching the video). The study lists 2 primary outcomes in all. 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 23 Oct 2024.