Clinical trial NCT06069193: 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
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Keywords: randomized controlled trial
placeboresponse
pain
doctor-patient interaction
treatment expectations
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants are assigned to one of two experimental groups in parallel for the duration of the study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain intensity (Numerical Rating Scale (NRS))
timeFrame: Pre-treatment (baseline); after the intervention (45 minutes after baseline); Post-treatment (1-week after baseline)
measure: Change in treatment expectation (Generic Rating for Treatment Pre-Experiences, Treatment Expectations, and Treatment Effects, G-EEE)
timeFrame: Pre-treatment (baseline); after the intervention (45 minutes after baseline)
measure: Treatment effects (Generic Rating for Treatment Pre-Experiences, Treatment Expectations, and Treatment Effects, G-EEE)
timeFrame: Post-treatment (1-week after baseline)]
Secondary outcomes:
measure: Perceived physician empathy (The consultation and relational empathy (CARE))
timeFrame: After the intervention (45 minutes after baseline)]
measure: Warmth and competence ratings of the practioner
timeFrame: After the intervention (45 minutes after baseline)
measure: Treatment adherence (Exercise Adherence Rating Scale (EARS))
timeFrame: Post-treatment (1-week after baseline)
measure: Adherence (Behavioral Measure)
timeFrame: Post-treatment (1-week after baseline)
Other outcomes:
measure: Sociodemographic variables
timeFrame: Baseline
measure: Warmth and competence ratings of the respondent
timeFrame: After the intervention (45 minutes after baseline)
measure: Attitude towards social touch (Social Touch Questionnaire (STQ))
timeFrame: Baseline
measure: Anxiety (State-Trait Anxiety Inventory (STAI))
timeFrame: Baseline
measure: Problems and Obstacles During the Intervention
timeFrame: Post-treatment (1-week after baseline)
measure: Experiences with Physiotherapy
timeFrame: Post-treatment (1-week after baseline)
measure: Parallel Treatments
timeFrame: Post-treatment (1-week after baseline)
Locations:
city: Marburg
country: Germany
facility: Germany Philipps University
Study officials:
affiliation: Dept. of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany
name: Winfried Rief, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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