Feasibility Trial of ScarWork for Post-breast Surgery Pain Syndrome.

NCT ID: NCT07206394

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-20
• Study Completion Date: 2026-06-30

Brief Summary

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.

Detailed Description

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:

• Standard care only, or
• Standard care plus ScarWork therapy (up to five individualised ScarWork sessions)

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.

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ScarWork plus standard care

Participant received up to 5 ScarWork sessions alongside usual standard of care

Group Type: ACTIVE_COMPARATOR

ScarWork therapy

Intervention Type: OTHER

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.

Standard care

Participants continue with their usual standard of care and symptom management without additional intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ScarWork therapy

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• Registering a score of ≥3 on perceived pain intensity or pain burden on a 10-point numerical rating scale (NRS)
• English speaking and able to communicate reasonably well
• Able to give informed consent
• Willing to attend for regular treatment at RLHIM

Exclusion Criteria

• History of post-breast surgery wound complications
• History of breast surgery unrelated to breast cancer treatment
• History of previous ScarWork therapy
• Diagnosis of lymphoedema
• Severe co-morbidities or cognitive disability
• Receiving physiotherapy for post-breast surgery pain syndrome at the time of trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of West London

OTHER

Sponsor Role: collaborator

University College London Hospitals

OTHER

Sponsor Role: lead

Responsible Party

John Hughes

Associate Professor/ Head of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Royal London Hospital for Integrated Medicine

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Nicole Collaco

Role: primary

nicole.collaco@nhs.net

+4489 484 435 22

John Hughes

Role: backup

john.hughes8@nhs.net

Other Identifiers

352185

Identifier Type: -

Identifier Source: org_study_id