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

Sponsor

Philipps University Marburg Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT06069193

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Behavioral: Touch Intervention Behavioral: Control	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

participants are assigned to one of two experimental groups in parallel for the duration of the studyparticipants are assigned to one of two experimental groups in parallel for the duration of the study

Masking:

Single (Participant)

Masking Description:

Participants were not aware which experimental condition they were allocated to.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 2, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Touch Intervention This group receives professional touch techniques, such as procedural touch.	Behavioral: Touch Intervention 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.
Experimental: Experimental: Control This group does not receive professional touch techniques and serves as the control for comparison.	Behavioral: Control 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.

Arm

Intervention/Treatment

Experimental: Experimental: Touch Intervention

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

Behavioral: Touch Intervention

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.

Experimental: Experimental: Control

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

Behavioral: Control

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.

Outcome Measures

Primary Outcome Measures

Change in pain intensity (Numerical Rating Scale (NRS)) [Pre-treatment (baseline); after the intervention (45 minutes after baseline); Post-treatment (1-week after baseline)]
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) [Pre-treatment (baseline); after the intervention (45 minutes after baseline)]
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) [Post-treatment (1-week after baseline)]]
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)) [After the intervention (45 minutes after baseline)]]
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 [After the intervention (45 minutes after baseline)]
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)) [Post-treatment (1-week after baseline)]
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) [Post-treatment (1-week after baseline)]
Self-report on the number of days participants have fully completed the prescribed exercises and properly applied the cream.

Other Outcome Measures

Sociodemographic variables [Baseline]
Gender, age, education, employment, nationality, mother tongue etc.
Warmth and competence ratings of the respondent [After the intervention (45 minutes after baseline)]
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.)
Attitude towards social touch (Social Touch Questionnaire (STQ)) [Baseline]
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).
Anxiety (State-Trait Anxiety Inventory (STAI)) [Baseline]
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.
Problems and Obstacles During the Intervention [Post-treatment (1-week after baseline)]
Problems with the execution of daily exercises were recorded in the online survey using an open response format.
Experiences with Physiotherapy [Post-treatment (1-week after baseline)]
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.
Parallel Treatments [Post-treatment (1-week after baseline)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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