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

NCT07206394 | Recruiting

• 1 other identifier: 352185
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

breast cancer; ScarWork; feasibility study

Outcome Measures

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

  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 (3)

• The Numeric Rating Scale

  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).

• Patient Scar Assessment Questionnaire (PSAQ)

  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).

• Measure Yourself Medical Outcome Profile (MYMOP)

  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).

Study Arms (2)

ScarWork plus standard care

ACTIVE COMPARATOR

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

Other: ScarWork therapy

Standard care

NO INTERVENTION

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

Interventions

ScarWork therapy 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.

ScarWork plus standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College London Hospitals: lead
• University of West London: collaborator

Study Sites (1)

Royal London Hospital for Integrated Medicine

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor/ Head of Research

Model Details: The study will employ a pragmatic mixed methods randomised parallel-group exploratory design.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: October 3, 2025
• Study Start: June 20, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)