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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Physical Touch on Treatment Outcomes and Patient Perception in Individuals With Back and Neck Pain: an Experimental Study

Conditions
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Pain

Intervention / Treatment
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* Behavioral: Touch Intervention
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Present complaints of back or neck pain Age of at least 18 years Proficiency in the German language 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 Initiation of new pain treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: participants are assigned to one of two experimental groups in parallel for the duration of the study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Touch Intervention<br>This group receives professional touch techniques, such as procedural touch. | Behavioral: Touch Intervention<br>* 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.<br>|
| Experimental: Experimental: Control<br>This group does not receive professional touch techniques and serves as the control for comparison. | Behavioral: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pre-treatment (baseline); after the intervention (45 minutes after baseline); Post-treatment (1-week after baseline) | 
| 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) | Pre-treatment (baseline); after the intervention (45 minutes after baseline) | 
| 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) | Post-treatment (1-week after baseline)] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | After the intervention (45 minutes after baseline)] | 
| 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.) | After the intervention (45 minutes after baseline) | 
| 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. | Post-treatment (1-week after baseline) | 
| Adherence (Behavioral Measure) | Self-report on the number of days participants have fully completed the prescribed exercises and properly applied the cream. | Post-treatment (1-week after baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized controlled trial, placeboresponse, pain, doctor-patient interaction, treatment expectations