NCT06175884

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 19, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

November 27, 2023

Last Update Submit

October 22, 2024

Conditions

Keywords

communication skillschronic musculoskeletal pain

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (9)

  • Pain Distribution

    Changes from baseline to10 minutes after watching the video

  • CSI: Central Sensitisation Inventory

    Baseline

  • BIPQ: Brief Illness Perception Questionnaire

    Changes from baseline to 10 minutes after watching the video

  • PCS: Pain Catastrophizing Scale

    Changes from baseline to 10 minutes after watching the video

  • STAI-40: State - Trait Anxiety Inventory

    Changes from baseline to 10 minutes after watching the video

  • +4 more secondary outcomes

Study Arms (3)

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.

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.

Other: Video about pain neuroscience education without enhancing communication skills

Control

NO INTERVENTION

Participants will not watch any video

Interventions

Participants will watch a brief video on pain neuroscience in which physiotherapist will show evidence-based communication skills to effectively convey information to patients.

Good 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.

Poor communication skills

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Thessaly

Lamia, 35132, Greece

RECRUITING

Study Officials

  • Eleni Kapreli

    University of Thessaly

    STUDY CHAIR

Central Study Contacts

Konstantina Savvoulidou

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 27, 2023

First Posted

December 19, 2023

Study Start

January 15, 2024

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

October 23, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations