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

NCT06069193 | Unknown

• 1 other identifier: PainTouchOutcomes
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

randomized controlled trial; placeboresponse; pain; doctor-patient interaction; treatment expectations

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Perceived physician empathy (The consultation and relational empathy (CARE))

  After the intervention (45 minutes after baseline)]

• Warmth and competence ratings of the practioner

  After the intervention (45 minutes after baseline)

• Treatment adherence (Exercise Adherence Rating Scale (EARS))

  Post-treatment (1-week after baseline)

• Adherence (Behavioral Measure)

  Post-treatment (1-week after baseline)

Other Outcomes (7)

• Sociodemographic variables

  Baseline

• Warmth and competence ratings of the respondent

  After the intervention (45 minutes after baseline)

• Attitude towards social touch (Social Touch Questionnaire (STQ))

  Baseline

Study Arms (2)

Experimental: Touch Intervention

EXPERIMENTAL

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

Behavioral: Touch Intervention

Experimental: Control

EXPERIMENTAL

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

Behavioral: Control

Interventions

Touch Intervention BEHAVIORAL

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: Touch Intervention

Control BEHAVIORAL

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.

Experimental: Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipps University Marburg: lead

Study Sites (1)

Germany Philipps University

Marburg, 35037, Germany

RECRUITING

Related Publications (22)

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MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Winfried Rief, Prof. Dr.

  Dept. of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatima Bouloukt, M.Sc.

CONTACT

+49 6421 28-24048; fatima.bouloukt@uni-marburg.de

Winfried Rief, Prof. Dr.

CONTACT

rief@staff.uni-marburg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were not aware which experimental condition they were allocated to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: participants are assigned to one of two experimental groups in parallel for the duration of the study

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 5, 2023
• Study Start: October 2, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)