An Individualised Treatment vs. a Minimal Program in Women With Late-term Shoulder Impairments After Breast Cancer.

NCT05277909 | Completed

• 1 other identifier: S-20200021, 19-16321
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Shoulder Pain; Late Effect; Breast Cancer; Rehabilitation

Keywords

Shoulder Impairments; Late Term; Breast Cancer; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Shoulder Pain and Disability Index (SPADI) from baseline to 12 weeks after initiating the treatment.

  SPADI is a 13-item patient-reported outcome measure to assess shoulder pain (5 items) and shoulder function (8 items) within the last week. The items are scored on a numeric rating scale that ranges from 0 (no pain/no difficulty) to 10 (worst pain/so difficult that required help). Each domain score is equally weighted and added to a total percentage score that ranges from 0 (best) to 100 (worst). The higher the score, patients reported shoulder impairments. The region specific questionnaire can be used in patients with different or unspecified shoulder diagnoses. SPADI is valid, reliable and responsible measure among patients with shoulder impairments.

  0, 4, 8 and 12 weeks

Secondary Outcomes (12)

• Change in SPADI pain from baseline to 12 weeks after initiating the treatment.

  0, 4, 8 and 12 weeks

• Change in SPADI function from baseline to 12 weeks after initiating the treatment.

  0, 4, 8 and 12 weeks

• SPADI clinical response.

  12 weeks (follow-up)

• Global Perceived Effect (GPE) measured at 4, 8 and 12 weeks after initiating the treatment.

  4, 8 and 12 weeks

• Change in Active Range Of Motion (A-ROM) in the affected shoulder from baseline to 12 weeks after initiating the treatment.

  0 and 12 weeks

Other Outcomes (3)

• Change in pain medication consumption from baseline to 12 weeks after initiating the treatment.

  0, 4, 8 and 12 weeks

• Change in Patient Health Questionnaire - 9 (PHQ-9) from baseline to 12 weeks after initiating the treatment.

  0, 4, 8 and 12 weeks

• Change in General Anxiety Disorder - 7 (GAD-7) from baseline to 12 weeks after initiating the treatment.

  0, 4, 8 and 12 weeks

Study Arms (2)

The expert assessment of shoulder impairments and individualised treatment plan

EXPERIMENTAL

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.

Other: The expert assessment of shoulder impairments and individualised treatment plan

A minimal physiotherapeutic rehabilitation program delivered in a pamphlet

ACTIVE COMPARATOR

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.

Other: A minimal physiotherapeutic rehabilitation program delivered in a pamphlet

Interventions

The expert assessment of shoulder impairments and individualised treatment plan OTHER

The participant's diagnosis based on the history, symptoms and clinical findings will be used to guide the individualised treatment plan.

The expert assessment of shoulder impairments and individualised treatment plan

A minimal physiotherapeutic rehabilitation program delivered in a pamphlet OTHER

This pamphlet contains a program with minimal exercise recommendations for the shoulder consisting of mobility, stretching, strength exercises and tissue treatment.

A minimal physiotherapeutic rehabilitation program delivered in a pamphlet

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Currently living in the Region of Southern Denmark or Central Denmark Region with a radius of 75 km from Vejle Hospital
• Between 18 and 71 age on time of surgery for primary breast cancer
• Indicate pain in chest and/or shoulder area (shoulder impairments) as the biggest problem/late-term effect in everyday life
• Indicate impaired shoulder function due to pain or due to tightness/tension
• Indicate shoulder pain at rest, during general activities, during sleep or during flexion, rotation or abduction of the shoulder
• A score ≥15 on the Disabilities of the Arm, Shoulder and Hand (Quick DASH)
• Agree to participate in this trial and signs written informed consent

You may not qualify if:

• No previous breast cancer (before 2014)
• Cancer relapse after the date of index surgery, cancer spread outside of thorax and axilla, tumor fixed to chest wall
• Primary- or secondary breast reconstruction performed at any time
• Severe lymphedema (an average score ≥ 70% in the first 7 questionnaires on the LYMPH-ICF-DK
• Bilateral breast cancer surgery
• Previous shoulder or upper limb fractures (left/right)
• Currently receiving chemo, immuno- or radiotherapy
• Co-morbidity expected to influence shoulder function (e.g. rheumatoid arthritis, previous stroke, multiple sclerosis)

Sponsors & Collaborators

• Vejle Hospital: lead
• Region of Southern Denmark: collaborator

Study Sites (1)

Department of Physio- and Occupational Therapy, Vejle Hospital

Vejle, 7100, Denmark

Location

Related Publications (2)

• Feder 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 DERIVED

• Feder 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 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Breast Neoplasms

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kim Gordon Ingwersen, PT, PhD

  Vejle Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 14, 2022
• Study Start: April 4, 2022
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available after publication of the trial.
• Access Criteria: Data access will be reviewed by the author group. Requestors will be required to sign a Data Access Agreement

Locations

DK (1)