Feasibility Trial of ScarWork for Post-breast Surgery Pain Syndrome.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity College London Hospitals
About this trial
Breast cancer is the most common cancer in women in the United Kingdom (UK). Most women are treated with a combination of surgery and radiotherapy. While these treatments are effective, they can cause ongoing breast pain for some, which can last months or even years. This long-term pain can have a major impact on quality of life, yet it is often overlooked and not well managed in routine care.
One in three women may still experience breast pain three years after treatment. The pain can come from scarring, tissue damage, or nerve changes caused by surgery and radiotherapy. Treatments for this pain are limited. Many patients are advised the pain will subside on its own or are given basic painkillers, which sometimes have limited impact.
ScarWork is a light-touch manual therapy, developed in the United States and aims to improve the way scars feel and look, reduce pain and tightness, and support healing. Although it has been available in the United Kingdom since 2014, there is very little research into whether ScarWork helps people who experience pain after breast cancer treatment.
This small study is a first step to see whether ScarWork could be a useful treatment for people who have experience breast pain after surgery and/or radiotherapy. The researchers want to know:
* Can this therapy be delivered in an NHS setting? * Do people find it helpful? * Is it worth doing a larger trial in the future?
Participants will be randomly placed in one of two groups: one group will continue with usual care, and the other will receive up to five sessions of ScarWork in addition to usual care. Everyone in the study will be asked to complete short questionnaires about their pain and other symptoms, before and after treatment, and again one month later. Participants will also be invited to talk about their experiences in a short phone or online interview.
This research will help show whether ScarWork might be a useful option for people dealing with breast pain after treatment. It will also help researchers design a larger trial in the future to test ScarWork more fully.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Over the age of 18
Early breast cancer patients who have had breast surgery with curative intent
Radiotherapy completed ≥ 6 months previously
In remission with no sign of active local disease
Disqualifiers
History of post-breast surgery wound complications
History of breast surgery unrelated to breast cancer treatment
History of previous ScarWork therapy
Diagnosis of lymphoedema
Trial design
Design model
Parallel
Treatments tested in this trial
ScarWork therapy
Other interventionScarWork is a manual therapy technique involving gentle, hands-on massage of scar tissue. It is designed to improve the mobility and integration of scar tissue, reduce discomfort, and support tissue healing. The approach is tailored to each individual, based on the characteristics of their scar and sensitivity of the surrounding tissue. It is commonly used with people recovering from surgery or radiotherapy to help address symptoms such as pain, tightness, numbness, or altered sensation. In this study, participants in the intervention group will receive up to five ScarWork sessions delivered by a trained therapist, in addition to standard care.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ScarWork plus standard careActive comparator 1 intervention
Group B: Standard careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
BREAST-Q Breast Conserving Therapy Module V2.0
A validated patient-reported outcome measure designed to evaluate outcomes among women undergoing breast conserving therapy, with the two overarching domains of 1) health-related quality of life and 2) patient satisfaction. Scales can be used selectively as appropriate to the research. For this study, we will measure: 1. Quality of life domains using: * Psychosocial Well-being scale comprises 10 items that ask about body image and a woman's confidence in social settings, as well as emotional health and self esteem. * Sexual Well-being scale comprises 6 items that ask about feelings of sexual attractiveness and confidence relating to breasts. * Physical Well-being * Chest scale comprises 9 items measuring problems in the breast area (tightness, pulling, tenderness, pain), activity limitations and sleep problems due to discomfort. * Adverse Effects of Radiation scale 2. Satisfaction with Breasts
Time frame
Baseline (Week 0, before first session), Week 12 (at final ScarWork session; control group same time point), Week 16 (4 weeks post-final session; control group same time point).Other outcomes
1
The Numeric Rating Scale
The Numeric Rating Scale (NRS), a widely used measure of pain intensity, provides a simple method for assessing pain across diverse clinical settings11. The NRS typically employs an 11-point scale, ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable (severe)." Patients are asked to select the number that best corresponds to their current level of pain intensity. The NRS's straightforward format allows for easy comprehension and administration, making it suitable for use with a wide range of patients, including those with cognitive impairments or language barriers. Its sensitivity to changes in pain intensity makes it a valuable tool for tracking response to ScarWork therapy and monitoring changes in pain. Total questions asked: 1
Time frame
Baseline (Week 0, before first session), Week 12 (at final ScarWork session; control group same time point), Week 16 (4 weeks post-final session; control group same time point).2
Patient Scar Assessment Questionnaire (PSAQ)
A validated patient-reported outcomes measure for scarring designed to allow patients to convey their opinion regarding linear scars and designed to evaluate the effect of any novel scar therapy.12 Comprising five subscales (Appearance, Symptoms, Consciousness, Satisfaction with Appearance, and Satisfaction with Symptoms) it is regarded as reliable and valid measure of the patient's perception of scarring. PSAQ will provide data specific to how women feel about their scar(s). Total questions asked: 39
Time frame
Baseline (Week 0, before first session), Week 12 (at final ScarWork session; control group same time point), Week 16 (4 weeks post-final session; control group same time point).3
Measure Yourself Medical Outcome Profile (MYMOP)
A validated, patient-generated (individualised) outcome questionnaire that is problem-specific but includes general wellbeing. Practical, reliable and sensitive to change, it has been widely used in studies investigating both complementary and orthodox interventions. Brief and simple to administer as part of the patient consultation, MYMOP captures the symptoms (physical, emotional or social) that the patient finds troublesome and in this study is intended to capture data about wider issues of scarring on daily life. 13 MYMOP provides informative data about what symptoms the patient finds most troublesome and is a means of gathering valuable data about the patients' experience and priorities. In addition, it contains a question about medications taken, which may provide useful information about pain relief and reduction of analgesics.
Time frame
Baseline (Week 0, before first session), Week 12 (at final ScarWork session; control group same time point), Week 16 (4 weeks post-final session; control group same time point).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University College London Hospitals
Lead sponsor
University of West London
Collaborator
Source ClinicalTrials.gov