Effectiveness of Physiotherapist's Communication Skills on Clinical Outcomes in Chronic Musculoskeletal Patients

Chronic Musculoskeletal Pain Clinical Trial

Official title:

Effectiveness of Physiotherapist's Communication Skills on Clinical Outcomes in Patients With Chronic Musculoskeletal Pain: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06175884
• Other study ID #: 10
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: April 30, 2024

Study information

• Verified date: January 2024
• Source: University of Thessaly
• Contact: Konstantina Savvoulidou
• Phone: +30 223 106 0235
• Email: ksavvoulidou[@]uth.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Musculoskeletal Pain
• Musculoskeletal Pain

Intervention

Other:
• Video about pain neuroscience education with enhancing communication skills
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 skills
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.

Locations

Country	Name	City	State
Greece	University of Thessaly	Lamia

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Changes from baseline to10 minutes after watching the video
Primary	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.	Changes from baseline to10 minutes after watching the video
Secondary	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.	Changes from baseline to10 minutes after watching the video
Secondary	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.	Baseline
Secondary	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.	Changes from baseline to 10 minutes after watching the video
Secondary	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.	Changes from baseline to 10 minutes after watching the video
Secondary	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.	Changes from baseline to 10 minutes after watching the video
Secondary	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.	Changes from baseline to 10 minutes after watching the video
Secondary	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.	Changes from baseline to 10 minutes after watching the video
Secondary	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.	Changes from baseline to 10 minutes after watching the video
Secondary	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").	Changes from baseline to 10 minutes after watching the video