Pain Clinical Trial
Official title:
Effects of Physical Touch on Treatment Outcomes and Patient Perception in Individuals With Back and Neck Pain: an Experimental Study
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Germany Philipps University | Marburg |
Lead Sponsor | Collaborator |
---|---|
Philipps University Marburg Medical Center |
Germany,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Sociodemographic variables | Gender, age, education, employment, nationality, mother tongue etc. | Baseline | |
Other | Warmth and competence ratings of the respondent | 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.) | After the intervention (45 minutes after baseline) | |
Other | Attitude towards social touch (Social Touch Questionnaire (STQ)) | 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). | Baseline | |
Other | Anxiety (State-Trait Anxiety Inventory (STAI)) | 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. | Baseline | |
Other | Problems and Obstacles During the Intervention | Problems with the execution of daily exercises were recorded in the online survey using an open response format. | Post-treatment (1-week after baseline) | |
Other | Experiences with Physiotherapy | 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. | Post-treatment (1-week after baseline) | |
Other | Parallel Treatments | 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. | Post-treatment (1-week after baseline) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | 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)] | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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