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Enhancing Treatment Outcomes: The Impact of Physical Touch in Back and Neck Pain Management

Primary Purpose

Pain

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Touch Intervention
Control
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring randomized controlled trial, placeboresponse, pain, doctor-patient interaction, treatment expectations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Present complaints of back or neck pain Age of at least 18 years Proficiency in the German language Absence of severe mental illness Willingness to engage in daily short exercise routines Exclusion Criteria: NRS <3 at baseline (0 = no pain and 10 = worst possible pain) Presence of contraindications for physical activity, such as severe disc diseases Presence of a severe medical condition Presence of an unstable medical or psychiatric condition Initiation of new pain medication

Sites / Locations

  • Germany Philipps UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental: Touch Intervention

Experimental: Control

Arm Description

This group receives professional touch techniques, such as procedural touch.

This group does not receive professional touch techniques and serves as the control for comparison.

Outcomes

Primary Outcome Measures

Change in pain intensity (Numerical Rating Scale (NRS))
Change in subjective pain intensity assessed using a numerical rating scales (NRS) ranging from 0 to 10, with higher values reflecting more pain intensity.
Change in treatment expectation (Generic Rating for Treatment Pre-Experiences, Treatment Expectations, and Treatment Effects, G-EEE)
Change from baseline in scores on the subscale for treatment expectations of the the generic rating scale for previous treatment experiences, treatment expectations, and treatment effects (GEEE) Treatment expectations are measured via the generic rating scale for previous treatment experiences, treatment expectations, and treatment effects (GEEE), subscale for previous treatment experiences and subscale for treatment expectations (Rief et al., 2021). Answers are provided on a numeric rating scale ranging from 0 to 10 (each item has specific anchors with lower anchors always indicating no expected effects)
Treatment effects (Generic Rating for Treatment Pre-Experiences, Treatment Expectations, and Treatment Effects, G-EEE)
Treatment effects are measured via the generic rating scale for previous treatment experiences, treatment expectations, and treatment effects (GEEE), subscale for previous treatment experiences and subscale for treatment expectations (Rief et al., 2021). Answers are provided on a numeric rating scale ranging from 0 to 10 (each item has specific anchors with lower anchors always indicating no expected effects)

Secondary Outcome Measures

Perceived physician empathy (The consultation and relational empathy (CARE))
This instrument, rated by patients, examines the quality of interpersonal interactions in healthcare encounters. It consists of ten items, each assessed on a 5-point scale ranging from 1 (strongly agree) to 5 (strongly disagree), with higher scores idicating reduced levels of empathy displayed by physicians.
Warmth and competence ratings of the practioner
Participant perceptions of warmth and competence of the practitioner are measured via the Warmth and Credibility Screener - German translation: 12 items assessing perceived warmth (6 items) and competence (6 items) on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely) with high scores indicating greater ratings of warmth and competence (Seewald & Rief, submitted for publication; English original by Fiske et al., 2002.)
Treatment adherence (Exercise Adherence Rating Scale (EARS))
The Exercise Adherence Rating Scale (EARS) is a self-administrated questionnaire designed to measure adherence to prescribed home-based exercises. The EARS consists of six items that measure adherence and 10 items related to reasons for nonadherence. The items were scored using a 5-point Likert scale ranging from 0 = completely agree to 4 = completely disagree with a possible summed score range from 0 to 64. Positively phrased items were reversed scored so that a higher overall adherence score indicated better adherence to exercise.
Adherence (Behavioral Measure)
Self-report on the number of days participants have fully completed the prescribed exercises and properly applied the cream.

Full Information

First Posted
October 1, 2023
Last Updated
October 16, 2023
Sponsor
Philipps University Marburg Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT06069193
Brief Title
Enhancing Treatment Outcomes: The Impact of Physical Touch in Back and Neck Pain Management
Official Title
Effects of Physical Touch on Treatment Outcomes and Patient Perception in Individuals With Back and Neck Pain: an Experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philipps University Marburg Medical Center

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
In this study, we aim to investigate the impact of professional touch techniques on treatment expectations and adherence in German-speaking adults with current back or neck pain. Participants will engage in a 45-minute interaction, including structured components and physical touch interventions. We will assess treatment expectations, treatment effects, adherence, and participant motivation. Our study will provide insights into the role of touch in healthcare interactions and its influence on treatment outcomes.
Detailed Description
Research findings indicate that the interaction between healthcare professionals and patients can significantly influence both treatment expectations and their effectiveness. A compassionate, caring, and attentive doctor-patient interaction plays a crucial role in patient satisfaction and promotes accelerated recovery. Moreover, patient expectations are not solely shaped by interactions with healthcare providers but are also conceptualized through conditioning processes as one of the key mechanisms of the placebo effect. The effective performance of medical staff can further intensify patient expectations, contributing to an increased placebo response. While the effects of verbal communication on the placebo effect have been extensively studied, there is less research on the impact of nonverbal factors such as touch. Touch is a fundamental aspect of social interaction that can positively affect well-being and health. Touch is regarded as a mechanism for the positive health effects of social relationships and plays a significant role in bonding, communication, and reward. Physical touch can provide patients with a sense of presence and grounding, helping them feel seen, reassured, relaxed, and validated. In medical treatment, touch can enhance a sense of being taken seriously and cared for, thereby alleviating suffering and improving well-being. However, the full range of communicative potential in professional touch remains largely untapped, while a well-founded interdisciplinary synthesis is still lacking. For the planned study, we aim to recruit German-speaking adult participants who report current back or neck pain. Recruitment will be carried out through targeted outreach via various channels such as mailing lists, internet forums, and flyers. In an online experiment, we will initially assess baseline treatment expectations and current pain intensity. Subsequently, participants will be randomized into two experimental conditions. Participants will engage in a 45-minute interaction, comprising a structured opening, a brief interview, a standardized diagnostic examination, a detailed explanation of the pain relief cream, specific exercises, and a final farewell. Within the two experimental groups, physical interaction, specifically the application of professional touch techniques, in the form of procedural touch (serving diagnostic or therapeutic purposes), will be manipulated by aspiring pain specialists to examine its influence on various treatment parameters such as treatment expectations, treatment effects, treatment adherence, and participant motivation. Additionally, perceived empathy as well as warmth and competence of the treating person will be analyzed as relevant factors. Following the interaction, participants will be asked to perform specific exercises daily for one week and apply a placebo cream. Adherence to these medical and behavioral measures is a critical outcome criterion. At the end of the study, a systematic assessment of relevant behavioral parameters will be conducted to quantify potential changes in participants' behavior related to the interventions performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
randomized controlled trial, placeboresponse, pain, doctor-patient interaction, treatment expectations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
participants are assigned to one of two experimental groups in parallel for the duration of the study
Masking
Participant
Masking Description
Participants were not aware which experimental condition they were allocated to.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Touch Intervention
Arm Type
Experimental
Arm Description
This group receives professional touch techniques, such as procedural touch.
Arm Title
Experimental: Control
Arm Type
Experimental
Arm Description
This group does not receive professional touch techniques and serves as the control for comparison.
Intervention Type
Behavioral
Intervention Name(s)
Touch Intervention
Intervention Description
The participants will be examined, with various areas in the neck and upper back being palpated. Subsequently, the exercises to be performed at home will be demonstrated by the experimenter. The experimenter will ensure correct execution by touching specific areas in the neck and upper back of the participants. Finally, the participants will be provided with a cream to be applied to the affected regions. Placebo cream: The participants receive an inert placebo cream, which is a standard basic cream infused with lemon oil, produced by a local pharmacy. Participants are informed that they are about to receive an effective analgesic cream. Placebo exercises: Participants are assigned a series of five core exercises, with an optional supplementary exercise available in case any of the core exercises proves ineffective for the participants. Participants are led to believe that these exercises are expected to have therapeutic effects.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
The participants will be examined, and they will be asked to describe as accurately as possible the regions where they experience pain. Subsequently, the experimenter will demonstrate the exercises to be performed at home. Finally, the participants will be provided with a cream to be applied to the affected regions. Placebo cream: The participants receive an inert placebo cream, which is a standard basic cream infused with lemon oil, produced by a local pharmacy. Participants are informed that they are about to receive an effective analgesic cream. Placebo exercises: Participants are assigned a series of five core exercises, with an optional supplementary exercise available in case any of the core exercises proves ineffective for the participants. Participants are led to believe that these exercises are expected to have therapeutic effects.
Primary Outcome Measure Information:
Title
Change in pain intensity (Numerical Rating Scale (NRS))
Description
Change in subjective pain intensity assessed using a numerical rating scales (NRS) ranging from 0 to 10, with higher values reflecting more pain intensity.
Time Frame
Pre-treatment (baseline); after the intervention (45 minutes after baseline); Post-treatment (1-week after baseline)
Title
Change in treatment expectation (Generic Rating for Treatment Pre-Experiences, Treatment Expectations, and Treatment Effects, G-EEE)
Description
Change from baseline in scores on the subscale for treatment expectations of the the generic rating scale for previous treatment experiences, treatment expectations, and treatment effects (GEEE) Treatment expectations are measured via the generic rating scale for previous treatment experiences, treatment expectations, and treatment effects (GEEE), subscale for previous treatment experiences and subscale for treatment expectations (Rief et al., 2021). Answers are provided on a numeric rating scale ranging from 0 to 10 (each item has specific anchors with lower anchors always indicating no expected effects)
Time Frame
Pre-treatment (baseline); after the intervention (45 minutes after baseline)
Title
Treatment effects (Generic Rating for Treatment Pre-Experiences, Treatment Expectations, and Treatment Effects, G-EEE)
Description
Treatment effects are measured via the generic rating scale for previous treatment experiences, treatment expectations, and treatment effects (GEEE), subscale for previous treatment experiences and subscale for treatment expectations (Rief et al., 2021). Answers are provided on a numeric rating scale ranging from 0 to 10 (each item has specific anchors with lower anchors always indicating no expected effects)
Time Frame
Post-treatment (1-week after baseline)]
Secondary Outcome Measure Information:
Title
Perceived physician empathy (The consultation and relational empathy (CARE))
Description
This instrument, rated by patients, examines the quality of interpersonal interactions in healthcare encounters. It consists of ten items, each assessed on a 5-point scale ranging from 1 (strongly agree) to 5 (strongly disagree), with higher scores idicating reduced levels of empathy displayed by physicians.
Time Frame
After the intervention (45 minutes after baseline)]
Title
Warmth and competence ratings of the practioner
Description
Participant perceptions of warmth and competence of the practitioner are measured via the Warmth and Credibility Screener - German translation: 12 items assessing perceived warmth (6 items) and competence (6 items) on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely) with high scores indicating greater ratings of warmth and competence (Seewald & Rief, submitted for publication; English original by Fiske et al., 2002.)
Time Frame
After the intervention (45 minutes after baseline)
Title
Treatment adherence (Exercise Adherence Rating Scale (EARS))
Description
The Exercise Adherence Rating Scale (EARS) is a self-administrated questionnaire designed to measure adherence to prescribed home-based exercises. The EARS consists of six items that measure adherence and 10 items related to reasons for nonadherence. The items were scored using a 5-point Likert scale ranging from 0 = completely agree to 4 = completely disagree with a possible summed score range from 0 to 64. Positively phrased items were reversed scored so that a higher overall adherence score indicated better adherence to exercise.
Time Frame
Post-treatment (1-week after baseline)
Title
Adherence (Behavioral Measure)
Description
Self-report on the number of days participants have fully completed the prescribed exercises and properly applied the cream.
Time Frame
Post-treatment (1-week after baseline)
Other Pre-specified Outcome Measures:
Title
Sociodemographic variables
Description
Gender, age, education, employment, nationality, mother tongue etc.
Time Frame
Baseline
Title
Warmth and competence ratings of the respondent
Description
Self-assessment of the subject's warmth and competence via the Warmth and Credibility Screener - German translation: 12 items assessing perceived warmth (6 items) and competence (6 items) on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely) with high scores indicating greater ratings of warmth and competence (Seewald & Rief, submitted for publication; English original by Fiske et al., 2002.)
Time Frame
After the intervention (45 minutes after baseline)
Title
Attitude towards social touch (Social Touch Questionnaire (STQ))
Description
The STQ assessed the individual attitude towards touch. It comprises 20 items that are to be answered on a 5-point Likert-scale from 0 (not at all) to 4 (extremely).
Time Frame
Baseline
Title
Anxiety (State-Trait Anxiety Inventory (STAI))
Description
The Spielberger State-Trait Anxiety Inventory (STAI) is a 40-item self-administered questionnaire designed to assess both immediate state anxiety (reflecting current feelings at the moment) and long-term trait anxiety (reflecting general anxiety tendencies) with 20 items each. Participants rate their responses on a 4-point Likert scale, ranging from 1 (indicating "not at all" for state anxiety or "almost never" for trait anxiety) to 4 (indicating "very much so" for state anxiety or "almost always" for trait anxiety. According to the developer (Spielberger, 1983), scores of 20-39, 40-59, and 60-80 indicate low, moderate, and high anxiety, respectively.
Time Frame
Baseline
Title
Problems and Obstacles During the Intervention
Description
Problems with the execution of daily exercises were recorded in the online survey using an open response format.
Time Frame
Post-treatment (1-week after baseline)
Title
Experiences with Physiotherapy
Description
The experience with physiotherapy is recorded on a 10-point scale from 0=never to 10=very frequent. High values represent a lot of experience with physiotherapy.
Time Frame
Post-treatment (1-week after baseline)
Title
Parallel Treatments
Description
Treatments that were received during the participation period are selected in the survey (e.g., primary care treatment, orthopedic treatment). If a treatment is not listed, there is an option to specify it in an open field.
Time Frame
Post-treatment (1-week after baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Present complaints of back or neck pain Age of at least 18 years Proficiency in the German language Absence of severe mental illness Willingness to engage in daily short exercise routines Exclusion Criteria: NRS <3 at baseline (0 = no pain and 10 = worst possible pain) Presence of contraindications for physical activity, such as severe disc diseases Presence of a severe medical condition Presence of an unstable medical or psychiatric condition Initiation of new pain medication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatima Bouloukt, M.Sc.
Phone
+49 6421 28-24048
Email
fatima.bouloukt@uni-marburg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Winfried Rief, Prof. Dr.
Email
rief@staff.uni-marburg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried Rief, Prof. Dr.
Organizational Affiliation
Dept. of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Germany Philipps University
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Winfried Rief, Prof. Dr.
Email
rief@staff.uni-marburg.de
First Name & Middle Initial & Last Name & Degree
Fatima Bouloukt, M.Sc.
Phone
+49 6421 28-24048
Email
fatima.bouloukt@uni-marburg.de

12. IPD Sharing Statement

Plan to Share IPD
No
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Enhancing Treatment Outcomes: The Impact of Physical Touch in Back and Neck Pain Management

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