NCT05277909

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

Completed NA Last updated 8 November 2022

What this trial tests

NA trial testing The expert assessment of shoulder impairments and individualised treatment plan in Shoulder Pain in 31 participants. Completed in 10 October 2022.

Timeline

4 April 2022

Primary endpoint
10 October 2022

10 October 2022

Quick facts

Lead sponsor	Vejle Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	31
Start date	4 April 2022
Primary completion	10 October 2022
Estimated completion	10 October 2022
Sites	1 location across Denmark

Drugs / interventions tested

• The expert assessment of shoulder impairments and individualised treatment plan
• A minimal physiotherapeutic rehabilitation program delivered in a pamphlet

Conditions studied

• Shoulder Pain — all drugs for Shoulder Pain →
• Late Effect — all drugs for Late Effect →
• Breast Cancer — all drugs for Breast Cancer →
• Rehabilitation — all drugs for Rehabilitation →

Sponsor

Vejle Hospital

Who can join

Adults 18 to 78, female only, with Shoulder Pain or Late Effect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Feder KM, Rahr HB, Lautrup MD, Egebæk HK, et al · · 2022 · cited 2× · PMID 35987857 · DOI 10.1186/s13063-022-06659-1
2. 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.
   Feder KM, Lautrup MD, Nielsen SM, Egebæk HK, et al · · 2025 · PMID 40105684 · DOI 10.2340/1651-226x.2025.42737