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

October 29, 2023 updated by: Philipps University Marburg Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain intensity (Numerical Rating Scale (NRS))
Time Frame: 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.
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)
Time Frame: 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)
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)
Time Frame: 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)
Post-treatment (1-week after baseline)]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived physician empathy (The consultation and relational empathy (CARE))
Time Frame: 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.
After the intervention (45 minutes after baseline)]
Warmth and competence ratings of the practioner
Time Frame: 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.)
After the intervention (45 minutes after baseline)
Treatment adherence (Exercise Adherence Rating Scale (EARS))
Time Frame: 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.
Post-treatment (1-week after baseline)
Adherence (Behavioral Measure)
Time Frame: 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.
Post-treatment (1-week after baseline)

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philipps University Marburg Medical Center

Investigators

  • Principal Investigator: Winfried Rief, Prof. Dr., Dept. of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 1, 2023

First Submitted That Met QC Criteria

October 1, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 29, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PainTouchOutcomes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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