Royal London Hospital for Integrated Medicine
London, United Kingdom
Location status: Recruiting
Location contact
John Hughes
CONTACT
Nicole Collaco
CONTACT
Nicole Collaco
SUB_INVESTIGATOR
NCT Number: NCT07206394
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
London, United Kingdom
Location status: Recruiting
John Hughes
CONTACT
Nicole Collaco
CONTACT
Nicole Collaco
SUB_INVESTIGATOR
Background Breast cancer is the most common cancer among women in the United Kingdom (UK). Each year, around 57,000 women are diagnosed. Many are treated with a combination of breast-conserving surgery (also known as a lumpectomy) and radiotherapy. These treatments are highly effective but can result in significant trauma to the breast tissue and skin, leading to long-term pain for some individuals.
Although short-term pain after surgery and radiotherapy is expected, some people go on to experience persistent and sometimes worsening pain long after the area has healed. This condition, often referred to as Post-Breast Surgery Pain Syndrome (PBSPS), can interfere with day-to-day life, emotional wellbeing, and recovery. Research suggests that as many as 40% of women still experience breast pain up to three years after treatment.
Despite this, there are currently few treatment options specifically targeting PBSPS. Most patients are offered basic pain relief or reassured that the pain will eventually fade. Surveys show that while most breast cancer specialists recognize this pain as a common issue, less than half routinely offer specific treatment for it.
ScarWork is a manual light touch therapy technique developed by therapist Sharon Wheeler in the United States. It involves gentle, targeted touch of scar tissue with the goal of improving tissue mobility, reducing pain and discomfort, and supporting healing. ScarWork has been used in the United Kingdom since 2014, but very little scientific research has been done to evaluate how effective it is, particularly for people experiencing post-surgery breast pain.
A previous evaluation found that cancer survivors who received ScarWork reported less pain, improved scar appearance and sensation, and a general reduction in symptoms. However, these findings were based on an early-stage service evaluation rather than a formal clinical trial.
About this study This feasibility study is designed to explore whether ScarWork can help people with early-stage breast cancer who are living with breast pain following surgery and/or radiotherapy. It will also assess whether delivering ScarWork within an NHS setting is practical and acceptable for both patients and healthcare providers.
The study is based at University College London Hospitals (UCLH) and is the first of its kind to investigate the use of ScarWork specifically for PBSPS in people treated with breast surgery.
Study design
Participants in this study will be randomly assigned to one of two groups:
The ScarWork treatment will be tailored to each participant's needs, in keeping with typical clinical practice. Outcome measures will be collected at the beginning of the study, after the final ScarWork session, and again four weeks after the treatment ends. This will help the research team assess both immediate and longer-term effects of the therapy.
Participants will complete questionnaires about their pain, scar-related symptoms, and general wellbeing. They will be able to complete these online, by post, or over the phone with a researcher. Those in the ScarWork group may also be invited to take part in a short interview to share their experiences of the treatment and the study process.
The findings will help researchers decide whether a larger, more detailed clinical trial is possible and worthwhile in the future.
Importance of study Pain after breast cancer treatment is common but under-recognised and under-treated. This study addresses an important gap in care by exploring a therapy that could provide relief to thousands of people living with post-treatment pain. By assessing ScarWork in a structured NHS setting, the study also helps build evidence for how complementary therapies can be integrated into cancer aftercare in a safe and measured way.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ScarWork 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.
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).
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:
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).
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).
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).
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.
University College London Hospitals
Other
A Feasibility Trial of ScarWork on Post-breast Surgery Pain Syndrome (PBSPS) in Early Stage Breast Cancer Patients.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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