PainNCT06069193
Enhancing Treatment Outcomes: The Impact of Physical Touch in Back and Neck Pain Management
A study testing Touch Intervention in people with Pain, run by Philipps University Marburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Touch Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 2 Oct 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Winfried Rief, Prof. Dr. contact
Germany1 site, 1 recruiting
- Recruiting
Germany Philipps University
Marburg, 35037
Winfried Rief, Prof. Dr., rief@staff.uni-marburg.de
Fatima Bouloukt, M.Sc., +49 6421 28-24048, fatima.bouloukt@uni-marburg.de
About this study
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Touch Intervention, Control
- Keywords
- randomized controlled trial, placeboresponse, pain, doctor-patient interaction, treatment expectations
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Touch InterventionBehavioural
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Touch Intervention | Experimental | This group receives professional touch techniques, such as procedural touch. Receives: Behavioral: Touch Intervention |
| Experimental: Control | Experimental | This group does not receive professional touch techniques and serves as the control for comparison. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: Post-treatment (1-week after baseline)]
Secondary outcomes (4)
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.
Measured: After the intervention (45 minutes after baseline)]
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.)
Measured: After the intervention (45 minutes after baseline)
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.
Measured: Post-treatment (1-week after baseline)
Adherence (Behavioral Measure)
Self-report on the number of days participants have fully completed the prescribed exercises and properly applied the cream.
Measured: Post-treatment (1-week after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start2 Oct 2023
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants are assigned to one of two experimental groups in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Winfried Rief, Prof. Dr., Principal investigator, Dept. of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069193
- Sponsor's protocol ID
- PainTouchOutcomes
- Status last verified
- Oct 2023
- First submitted
- 1 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prichard C, Newcomb P. Benefit to Family Members of Delivering Hand Massage With Essential Oils to Critically Ill Patients. Am J Crit Care. 2015 Sep;24(5):446-9. doi: 10.4037/ajcc2015767.
PubMed 26330438Carter A, Sanderson H. Complementary therapy. The use of touch in nursing practice. Nurs Stand. 1995 Jan 11-17;9(16):31-5. doi: 10.7748/ns.9.16.31.s37.
PubMed 7888321Chang SO. The conceptual structure of physical touch in caring. J Adv Nurs. 2001 Mar;33(6):820-7. doi: 10.1046/j.1365-2648.2001.01721.x.
PubMed 11298220Cocksedge S, George B, Renwick S, Chew-Graham CA. Touch in primary care consultations: qualitative investigation of doctors' and patients' perceptions. Br J Gen Pract. 2013 Apr;63(609):e283-90. doi: 10.3399/bjgp13X665251.
PubMed 23540485Czerniak E, Biegon A, Ziv A, Karnieli-Miller O, Weiser M, Alon U, Citron A. Manipulating the Placebo Response in Experimental Pain by Altering Doctor's Performance Style. Front Psychol. 2016 Jun 30;7:874. doi: 10.3389/fpsyg.2016.00874. eCollection 2016.
PubMed 27445878Fiske ST, Cuddy AJ, Glick P, Xu J. A model of (often mixed) stereotype content: competence and warmth respectively follow from perceived status and competition. J Pers Soc Psychol. 2002 Jun;82(6):878-902.
PubMed 12051578Fuentes J, Armijo-Olivo S, Funabashi M, Miciak M, Dick B, Warren S, Rashiq S, Magee DJ, Gross DP. Enhanced therapeutic alliance modulates pain intensity and muscle pain sensitivity in patients with chronic low back pain: an experimental controlled study. Phys Ther. 2014 Apr;94(4):477-89. doi: 10.2522/ptj.20130118. Epub 2013 Dec 5.
PubMed 24309616Gallace A, Spence C. The science of interpersonal touch: an overview. Neurosci Biobehav Rev. 2010 Feb;34(2):246-59. doi: 10.1016/j.neubiorev.2008.10.004. Epub 2008 Oct 17.
PubMed 18992276Kaptchuk TJ. The placebo effect in alternative medicine: can the performance of a healing ritual have clinical significance? Ann Intern Med. 2002 Jun 4;136(11):817-25. doi: 10.7326/0003-4819-136-11-200206040-00011.
PubMed 12044130Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, Kirsch I, Schyner RN, Nam BH, Nguyen LT, Park M, Rivers AL, McManus C, Kokkotou E, Drossman DA, Goldman P, Lembo AJ. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ. 2008 May 3;336(7651):999-1003. doi: 10.1136/bmj.39524.439618.25. Epub 2008 Apr 3.
PubMed 18390493Kelley JM, Lembo AJ, Ablon JS, Villanueva JJ, Conboy LA, Levy R, Marci CD, Kerr CE, Kirsch I, Jacobson EE, Riess H, Kaptchuk TJ. Patient and practitioner influences on the placebo effect in irritable bowel syndrome. Psychosom Med. 2009 Sep;71(7):789-97. doi: 10.1097/PSY.0b013e3181acee12. Epub 2009 Aug 6.
PubMed 19661195Kelly MA, Nixon L, McClurg C, Scherpbier A, King N, Dornan T. Experience of Touch in Health Care: A Meta-Ethnography Across the Health Care Professions. Qual Health Res. 2018 Jan;28(2):200-212. doi: 10.1177/1049732317707726. Epub 2017 May 11.
PubMed 29235944Kim SS, Kaplowitz S, Johnston MV. The effects of physician empathy on patient satisfaction and compliance. Eval Health Prof. 2004 Sep;27(3):237-51. doi: 10.1177/0163278704267037.
PubMed 15312283Lapp HS, Croy I. Insights from the German Version of the Social Touch Questionnaire: How Attitude towards Social Touch relates to Symptoms of Social Anxiety. Neuroscience. 2021 Jun 1;464:133-142. doi: 10.1016/j.neuroscience.2020.07.012. Epub 2020 Jul 13.
PubMed 32673628Mercer SW, Maxwell M, Heaney D, Watt GC. The consultation and relational empathy (CARE) measure: development and preliminary validation and reliability of an empathy-based consultation process measure. Fam Pract. 2004 Dec;21(6):699-705. doi: 10.1093/fampra/cmh621. Epub 2004 Nov 4.
PubMed 15528286
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Touch on Treatment Outcomes and Patient Perception in Individuals With Back and Neck Pain: an Experimental Study
- ClinicalTrials.gov ID
- NCT06069193
- Acronym / sponsor ID
- PainTouchOutcomes
- Conditions
- Pain
- Keywords
- randomized controlled trial, placeboresponse, pain, doctor-patient interaction, treatment expectations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- participants are assigned to one of two experimental groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Experimental: Touch Intervention | Experimental | Behavioral: Touch InterventionThis group receives professional touch techniques, such as procedural touch. |
| Experimental: Control | Experimental | Behavioral: ControlThis group does not receive professional touch techniques and serves as the control for comparison. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Touch InterventionThe 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. | Behavioural | Experimental: Touch Intervention |
| ControlThe 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. | Behavioural | Experimental: Control |
Primary outcome
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.
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)
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)
4 secondary outcomes
Perceived physician empathy (The consultation and relational empathy (CARE))
Time frame: After the intervention (45 minutes after baseline)]
Warmth and competence ratings of the practioner
Time frame: After the intervention (45 minutes after baseline)
Treatment adherence (Exercise Adherence Rating Scale (EARS))
Time frame: Post-treatment (1-week after baseline)
Adherence (Behavioral Measure)
Time frame: Post-treatment (1-week after baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 26330438Prichard C, Newcomb P. Benefit to Family Members of Delivering Hand Massage With Essential Oils to Critically Ill Patients. Am J Crit Care. 2015 Sep;24(5):446-9. doi: 10.4037/ajcc2015767.
- Background: PubMed 7888321Carter A, Sanderson H. Complementary therapy. The use of touch in nursing practice. Nurs Stand. 1995 Jan 11-17;9(16):31-5. doi: 10.7748/ns.9.16.31.s37.
- Background: PubMed 11298220Chang SO. The conceptual structure of physical touch in caring. J Adv Nurs. 2001 Mar;33(6):820-7. doi: 10.1046/j.1365-2648.2001.01721.x.
- Background: PubMed 23540485Cocksedge S, George B, Renwick S, Chew-Graham CA. Touch in primary care consultations: qualitative investigation of doctors' and patients' perceptions. Br J Gen Pract. 2013 Apr;63(609):e283-90. doi: 10.3399/bjgp13X665251.
- Background: PubMed 27445878Czerniak E, Biegon A, Ziv A, Karnieli-Miller O, Weiser M, Alon U, Citron A. Manipulating the Placebo Response in Experimental Pain by Altering Doctor's Performance Style. Front Psychol. 2016 Jun 30;7:874. doi: 10.3389/fpsyg.2016.00874. eCollection 2016.
- Background: PubMed 12051578Fiske ST, Cuddy AJ, Glick P, Xu J. A model of (often mixed) stereotype content: competence and warmth respectively follow from perceived status and competition. J Pers Soc Psychol. 2002 Jun;82(6):878-902.
- Background: PubMed 24309616Fuentes J, Armijo-Olivo S, Funabashi M, Miciak M, Dick B, Warren S, Rashiq S, Magee DJ, Gross DP. Enhanced therapeutic alliance modulates pain intensity and muscle pain sensitivity in patients with chronic low back pain: an experimental controlled study. Phys Ther. 2014 Apr;94(4):477-89. doi: 10.2522/ptj.20130118. Epub 2013 Dec 5.
- Background: PubMed 18992276Gallace A, Spence C. The science of interpersonal touch: an overview. Neurosci Biobehav Rev. 2010 Feb;34(2):246-59. doi: 10.1016/j.neubiorev.2008.10.004. Epub 2008 Oct 17.
- Background: PubMed 12044130Kaptchuk TJ. The placebo effect in alternative medicine: can the performance of a healing ritual have clinical significance? Ann Intern Med. 2002 Jun 4;136(11):817-25. doi: 10.7326/0003-4819-136-11-200206040-00011.
- Background: PubMed 18390493Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, Kirsch I, Schyner RN, Nam BH, Nguyen LT, Park M, Rivers AL, McManus C, Kokkotou E, Drossman DA, Goldman P, Lembo AJ. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ. 2008 May 3;336(7651):999-1003. doi: 10.1136/bmj.39524.439618.25. Epub 2008 Apr 3.
- Background: PubMed 19661195Kelley JM, Lembo AJ, Ablon JS, Villanueva JJ, Conboy LA, Levy R, Marci CD, Kerr CE, Kirsch I, Jacobson EE, Riess H, Kaptchuk TJ. Patient and practitioner influences on the placebo effect in irritable bowel syndrome. Psychosom Med. 2009 Sep;71(7):789-97. doi: 10.1097/PSY.0b013e3181acee12. Epub 2009 Aug 6.
- Background: PubMed 29235944Kelly MA, Nixon L, McClurg C, Scherpbier A, King N, Dornan T. Experience of Touch in Health Care: A Meta-Ethnography Across the Health Care Professions. Qual Health Res. 2018 Jan;28(2):200-212. doi: 10.1177/1049732317707726. Epub 2017 May 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried Rief, Prof. Dr. contact
Winfried Rief, Prof. Dr. principal investigator
Dept. of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Touch Intervention in people with Pain, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatima Bouloukt, M.Sc. (+49 6421 28-24048, fatima.bouloukt@uni-marburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06069193, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.