Clinical trial · Interventional
An Individualised Treatment vs. a Minimal Program in Women With Late-term Shoulder Impairments After Breast Cancer.
Effectiveness of an Expert Assessment and Individualised Treatment in Comparison to a Minimal Home-based Exercise Program in Women With Late-term Shoulder Impairments After Primary Breast Cancer Surgery.
NCT05277909CI-TRIAL-00062016completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In breast cancer patients late-term upper limb sequelae, such as shoulder pain and impaired shoulder function remain common after primary breast cancer surgery. The aim of this trial is to evaluate whether an expert assessment of shoulder impairments, followed by an individualised treatment plan, is superior to a minimal physiotherapeutic rehabilitation program in reducing shoulder symptoms, assessed 12 weeks after initiation of treatment, among women with late-term shoulder impairments after primary breast cancer surgery.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Late Effect | — | UNRESOLVED | — |
| Rehabilitation | — | UNRESOLVED | — |
| Shoulder Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A minimal physiotherapeutic rehabilitation program delivered in a pamphlet | Other | — | UNRESOLVED |
| The expert assessment of shoulder impairments and individualised treatment plan | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- The expert assessment of shoulder impairments and individualised treatment plan
- description
- Participants randomised to the Intervention group will be referred to an expert assessment of their shoulder impairments at the Shoulder Sector, Vejle Hospital - Orthopaedic Department. The expert assessment will be performed by experienced specialists (e.g. physician and physiotherapist) who are specialised in shoulder diagnostics using x-ray, ultrasound, anamnesis/history and standard clinical tests such as Neers, Hawkins, Jobe´s Empty Can, Painful Arc and Resisted External Rotation. The participant's diagnosis based on the history, symptoms and clinical findings will be used to guide the individualised treatment plan. The individualised treatment plan will typically contain a referral to physiotherapeutic treatment at the municipality or private practice, receive specialised physiotherapeutic rehabilitation at Vejle Hospital, get an ultrasound guided corticosteroid injection in the shoulder or offer surgery.
- interventionNames
- Other: The expert assessment of shoulder impairments and individualised treatment plan
- type
- ACTIVE_COMPARATOR
- label
- A minimal physiotherapeutic rehabilitation program delivered in a pamphlet
- description
- Participants randomised to the Control comparator group will receive a pamphlet from the secretary and perform the exercises at home. This pamphlet contains a program with minimal exercise recommendations for the shoulder consisting of mobility, stretching, strength exercises and tissue treatment. The purpose is to stimulate circulation, improve shoulder function (mobility), increase muscle strength and reduce shoulder pain. The program consists of three warm-up exercises (arm swing, shoulder rolling and scapula-back pocket exercise) followed by three stretching exercises for the breast and shoulder area. Furthermore the pamphlet includes a tissue treatment and four strength exercises for the shoulder (external rotation, extension and flexion of the shoulder and diagonal pull apart). Mobility (with 5-10 repetitions), stretching exercises (in 30 seconds) and tissue treatments will be performed twice a day, while the strength exercises will be performed once a day with 3x12 repetitions.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 78 Years
Show eligibility criteria text
Inclusion Criteria: 1. Breast cancer patients who underwent unilateral BCS or mastectomy on the left or right side, including SLND or +/- ALND within the last 3-7 years (2015-2019) 2. Currently living in the Region of Southern Denmark or Central Denmark Region with a radius of 75 km from Vejle Hospital 3. Between 18 and 71 age on time of surgery for primary breast cancer 4. Indicate pain in chest and/or shoulder area (shoulder impairments) as the biggest problem/late-term effect in everyday life 5. Indicate impaired shoulder function due to pain or due to tightness/tension 6. Indicate shoulder pain at rest, during general activities, during sleep or during flexion, rotation or abduction of the shoulder 7. A score ≥15 on the Disabilities of the Arm, Shoulder and Hand (Quick DASH) 8. Agree to participate in this trial and signs written informed consent Exclusion Criteria: 1. No previous breast cancer (before 2014) 2. Cancer relapse after the date of index surgery, cancer spread outside of thorax and axilla, tumor fixed to chest wall 3. Primary- or secondary breast reconstruction performed at any time 4. Severe lymphedema (an average score ≥ 70% in the first 7 questionnaires on the LYMPH-ICF-DK 5. Bilateral breast cancer surgery 6. Previous surgery in the affected shoulder (prior to inclusion) 7. Previous shoulder or upper limb fractures (left/right) 8. Currently receiving chemo, immuno- or radiotherapy 9. Co-morbidity expected to influence shoulder function (e.g. rheumatoid arthritis, previous stroke, multiple sclerosis) 10. Other reasons for exclusion (e.g. pregnancy, not legally competent, unable to comprehend the information or unable to consent)
References
Publications (2)
- DERIVEDFeder KM, Lautrup MD, Nielsen SM, Egebaek HK, Rahr HB, Christensen R, Ingwersen KG. Effectiveness of an individualised treatment plan compared with a standard exercise programme in women with late-term shoulder impairments after primary breast cancer treatment: a randomised controlled trial. Acta Oncol. 2025 Mar 19;64:448-457. doi: 10.2340/1651-226X.2025.42737. PMID 40105684
- DERIVEDFeder KM, Rahr HB, Lautrup MD, Egebaek HK, Christensen R, Ingwersen KG. Effectiveness of an expert assessment and individualised treatment compared with a minimal home-based exercise program in women with late-term shoulder impairments after primary breast cancer surgery: study protocol for a randomised controlled trial. Trials. 2022 Aug 20;23(1):701. doi: 10.1186/s13063-022-06659-1. PMID 35987857