Shoulder PainNCT05277909
An Individualised Treatment vs. a Minimal Program in Women With Late-term Shoulder Impairments After Breast Cancer.
A study testing The expert assessment of shoulder impairments and individualised treatment plan and A minimal physiotherapeutic rehabilitation program delivered in a pamphlet in people with Shoulder Pain and Late Effect, run by Vejle Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 78 years, women only
- Conditions the study is for
- Shoulder Pain, Late Effect, Breast Cancer
- What is being tested?
- The expert assessment of shoulder impairments and individualised treatment plan and A minimal physiotherapeutic rehabilitation program delivered in a pamphlet
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Apr 2022to 10 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 surgery in the affected shoulder (prior to inclusion)
Show all 10Show fewer
- 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)
- Other reasons for exclusion (e.g. pregnancy, not legally competent, unable to comprehend the information or unable to consent)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Physio- and Occupational Therapy, Vejle Hospital
Vejle, 7100
About this study
Official title: 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.
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.
Read the detailed description
Worldwide, breast cancer is the second most common cancer. Internationally, an age-standardised incidence rate between 83.1 and 111.9 per 100.000 women is seen, with Denmark taking an unfortunate second place. Standard surgical treatment in Denmark is breast-conserving surgery (BCS) or mastectomy in combination with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND). In part due to early diagnosis and optimised treatment methods, 5-year survival has improved to a current 87%. Despite fewer mastectomies and more BCS, less invasive surgical procedures of the axilla (e.g. fewer ALND vs. SLND), and more refined radiotherapy procedures, late-term upper limb impairment still remains common. The most frequent are lymphoedema, sensory disturbances, pain and impaired shoulder function, with up to 70% of patients reporting at least one of these symptoms three years after surgery. These impairments lead to difficulties in activities of daily living, increased risk of depression and anxiety and decreased quality of life (QoL).
Previous research has primarily focused on prevention and treatment of lymphedema, and less on other upper limb impairments. Pre- and early postoperative physiotherapeutic interventions are known to be effective in reducing shoulder pain and improving shoulder function after breast cancer treatment. Nonetheless, late-term upper limb impairments need further focus with prevalence´s of up to 50% is reported for impaired shoulder function and pain up to 6 years after surgery, and a substantial knowledge gap exists as to how to help these women. Currently, no standardised evaluation of their impairments or treatment is offered, and it is therefore up to the individual woman to seek care, resulting in large variations in rehabilitation. Thus a substantial knowledge gap exists in how to meet the rehabilitation needs of these women and evaluation of the actual burden of late-term shoulder impairments after primary treatment for breast cancer and the effect of different treatment strategies is warranted.
The primary aim of this study is to investigate whether the effect of a patient-centred specialised intervention, consisting of an expert assessment followed by an individualised treatment plan (i.e. Intervention group), is superior to a minimal physiotherapeutic rehabilitation program delivered in a pamphlet (i.e. Control comparator group) among women with late-term shoulder impairments 3-7 years after their primary breast cancer surgery. The hypothesis is that women randomised to the Intervention Group will improve significantly more in shoulder function and pain 12 weeks after initiating the treatment than those randomised to the Control comparator group.
This trial is a stratified (by type of surgery and radiotherapy), block randomised (1:1 allocation), controlled, parallel group and assessor blinded superiority trial conducted in Denmark. 130 participants with late-term shoulder impairments 3-7 years after primary surgery for breast cancer will be recruited.
- Conditions
- Shoulder Pain, Late Effect, Breast Cancer, Rehabilitation
- Being tested
- The expert assessment of shoulder impairments and individualised treatment plan, A minimal physiotherapeutic rehabilitation program delivered in a pamphlet
- Keywords
- Shoulder Impairments, Late Term, Breast Cancer, Rehabilitation
- Medical subject headings
- Shoulder Pain, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The expert assessment of shoulder impairments and individualised treatment planOther
The participant's diagnosis based on the history, symptoms and clinical findings will be used to guide the individualised treatment plan.
A minimal physiotherapeutic rehabilitation program delivered in a pamphletOther
This pamphlet contains a program with minimal exercise recommendations for the shoulder consisting of mobility, stretching, strength exercises and tissue treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: A minimal physiotherapeutic rehabilitation program delivered in a pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 4, 8 and 12 weeks
Secondary outcomes (12)
Change in SPADI pain from baseline to 12 weeks after initiating the treatment.
Change in SPADI pain will be reported as a separate subscale. The 5-item pain subscale are scored on a numeric rating scale that ranges from 0 (no pain) to 10 (worst pain). The higher the score, patients report greater shoulder pain and reduction in the SPADI pain score will suggest improvement.
Measured: 0, 4, 8 and 12 weeks
Change in SPADI function from baseline to 12 weeks after initiating the treatment.
Change in SPADI function will be reported as a separate subscale. A 6-item version (exclusion of question three and seven) of the disability subscale exhibited adequate fit in the Danish version. The 6-item disability subscale are scored on a numeric rating scale that ranges from 0 (no difficulty) to 10 (so difficult that required help). The higher the score, patients report greater shoulder disabilities and reduction in the SPADI function score will suggest improvement.
Measured: 0, 4, 8 and 12 weeks
SPADI clinical response.
Response to treatment will be computed for the SPADI change score for each woman in both treatment groups and presented dichotomised (i.e. responder and non-responder) as number (and percentages) responders. Women will be classified as an responder if the SPADI change score improves by 8 points or more (≥), corresponding to the minimal clinically important difference on SPADI from baseline to 12 weeks follow-up.
Measured: 12 weeks (follow-up)
Global Perceived Effect (GPE) measured at 4, 8 and 12 weeks after initiating the treatment.
The GPE will evaluate the impression of the treatment's success including overall shoulder problems on a 7-point Likert scale ranging from "markedly worse" to "markedly improved".
Measured: 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.
A smartphone inclinometer (GetMyROM) will be used to assess A-ROM in flexion, internal rotation, external rotation and abduction respectively the operated side. After one test trial, the mean value of three measurements will be taken for both flexion, rotation and abduction respectively the operated side.
Measured: 0 and 12 weeks
Change in Passive Range Of Motion (P-ROM) in the affected shoulder from baseline to 12 weeks after initiating the treatment.
A smartphone inclinometer (GetMyROM) will be used to assess P-ROM in flexion, internal rotation, external rotation and abduction respectively the operated side. After one test trial, the mean value of three measurements will be taken for both flexion, rotation and abduction respectively the operated side.
Measured: 0 and 12 weeks
Number of treatments received due to shoulder symptoms from baseline to 12 weeks after initiating the treatment.
Number of visits to a healthcare professional (e.g. physician, chiropractor or physiotherapist) at hospital, municipality rehabilitation or private practice due to the shoulder symptoms during the intervention period, will be collected by using a patient-reported questionnaire.
Measured: 12 weeks (follow up)
Change in maximum shoulder pain intensity within the previous 24 hours in the affected shoulder measured by Numeric Rating Scale (NRS) from baseline to 12 weeks after initiating the treatment.
The NRS pain scale is a single 11-item patient reported outcome measure used to assess the maximum shoulder pain intensity. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). The higher the score, patients report greater shoulder pain intensity and reduction in the NRS score will suggest improvement. The NRS is a reliable, valid and responsive measure of pain in patients with cancer.
Measured: 0, 4, 8 and 12 weeks
Change in shoulder pain during general activities within the previous 24 hours in the affected shoulder measured by Numeric Rating Scale (NRS) from baseline to 12 weeks after initiating the treatment.
The NRS pain scale is a single 11-item patient reported outcome measure used to assess pain during general activities. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). The higher the score, patients report greater shoulder pain and reduction in the NRS score will suggest improvement. The NRS is a reliable, valid and responsive measure of pain in patients with cancer.
Measured: 0, 4, 8 and 12 weeks
Change in shoulder pain at rest within the previous 24 hours in the affected shoulder measured by Numeric Rating Scale (NRS) from baseline to 12 weeks after initiating the treatment.
The NRS pain scale is a single 11-item patient reported outcome measure used to assess pain at rest. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). The higher the score, patients report greater shoulder pain and reduction in the NRS score will suggest improvement. The NRS is a reliable, valid and responsive measure of pain in patients with cancer.
Measured: 0, 4, 8 and 12 weeks
Change in shoulder pain during sleep within the previous 24 hours in the affected shoulder measured by Numeric Rating Scale (NRS) from baseline to 12 weeks after initiating the treatment.
The NRS pain scale is a single 11-item patient reported outcome measure used to assess pain during sleep. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). The higher the score, patients report greater shoulder pain and reduction in the NRS score will suggest improvement. The NRS is a reliable, valid and responsive measure of pain in patients with cancer.
Measured: 0, 4, 8 and 12 weeks
Change in shoulder pain assessment during flexion/rotation/abduction in the affected shoulder measured by Numeric Rating Scale (NRS) from baseline to 12 weeks after initiating the treatment.
The NRS pain scale is a single 11-item patient reported outcome measure used to assess pain during flexion/rotation/abduction. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). The higher the score, patients report greater shoulder pain and reduction in the NRS score will suggest improvement. The NRS is a reliable, valid and responsive measure of pain in patients with cancer.
Measured: 0 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start4 Apr 2022
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Kim Gordon Ingwersen, PT, PhD, Principal investigator, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277909
- Sponsor's protocol ID
- S-20200021, 19-16321
- Status last verified
- Nov 2022
- First submitted
- 3 Mar 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Personal data for the primary and all secondary outcome measures will only be made available if required by the scientific journal, in which the result of the trial are published.
Publications
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.
PubMed 40105684Feder 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.
PubMed 35987857
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05277909
- Acronym / sponsor ID
- S-20200021, 19-16321
- Conditions
- Shoulder Pain, Late Effect, Breast Cancer, Rehabilitation
- Keywords
- Shoulder Impairments, Late Term, Breast Cancer, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Collaborators
- Region of Southern Denmark
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Worldwide, breast cancer is the second most common cancer. Internationally, an age-standardised incidence rate between 83.1 and 111.9 per 100.000 women is seen, with Denmark taking an unfortunate second place. Standard surgical treatment in Denmark is breast-conserving surgery (BCS) or mastectomy in combination with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND). In part due to early diagnosis and optimised treatment methods, 5-year survival has improved to a current 87%. Despite fewer mastectomies and more BCS, less invasive surgical procedures of the axilla (e.g. fewer ALND vs. SLND), and more refined radiotherapy procedures, late-term upper limb impairment still remains common. The most frequent are lymphoedema, sensory disturbances, pain and impaired shoulder function, with up to 70% of patients reporting at least one of these symptoms three years after surgery. These impairments lead to difficulties in activities of daily living, increased risk of depression and anxiety and decreased quality of life (QoL).
Previous research has primarily focused on prevention and treatment of lymphedema, and less on other upper limb impairments. Pre- and early postoperative physiotherapeutic interventions are known to be effective in reducing shoulder pain and improving shoulder function after breast cancer treatment. Nonetheless, late-term upper limb impairments need further focus with prevalence´s of up to 50% is reported for impaired shoulder function and pain up to 6 years after surgery, and a substantial knowledge gap exists as to how to help these women. Currently, no standardised evaluation of their impairments or treatment is offered, and it is therefore up to the individual woman to seek care, resulting in large variations in rehabilitation. Thus a substantial knowledge gap exists in how to meet the rehabilitation needs of these women and evaluation of the actual burden of late-term shoulder impairments after primary treatment for breast cancer and the effect of different treatment strategies is warranted.
The primary aim of this study is to investigate whether the effect of a patient-centred specialised intervention, consisting of an expert assessment followed by an individualised treatment plan (i.e. Intervention group), is superior to a minimal physiotherapeutic rehabilitation program delivered in a pamphlet (i.e. Control comparator group) among women with late-term shoulder impairments 3-7 years after their primary breast cancer surgery. The hypothesis is that women randomised to the Intervention Group will improve significantly more in shoulder function and pain 12 weeks after initiating the treatment than those randomised to the Control comparator group.
This trial is a stratified (by type of surgery and radiotherapy), block randomised (1:1 allocation), controlled, parallel group and assessor blinded superiority trial conducted in Denmark. 130 participants with late-term shoulder impairments 3-7 years after primary surgery for breast cancer will be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The expert assessment of shoulder impairments and individualised treatment plan | Experimental | Other: The expert assessment of shoulder impairments and individualised treatment planParticipants 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. |
| A minimal physiotherapeutic rehabilitation program delivered in a pamphlet | Active comparator | Other: A minimal physiotherapeutic rehabilitation program delivered in a pamphletParticipants 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. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The expert assessment of shoulder impairments and individualised treatment planThe participant's diagnosis based on the history, symptoms and clinical findings will be used to guide the individualised treatment plan. | Other | The expert assessment of shoulder impairments and individualised treatment plan |
| A minimal physiotherapeutic rehabilitation program delivered in a pamphletThis pamphlet contains a program with minimal exercise recommendations for the shoulder consisting of mobility, stretching, strength exercises and tissue treatment. | Other | A minimal physiotherapeutic rehabilitation program delivered in a pamphlet |
Primary outcome
Change in Shoulder Pain and Disability Index (SPADI) from baseline to 12 weeks after initiating the treatment.
Time frame: 0, 4, 8 and 12 weeks
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.
12 secondary outcomes
Change in SPADI pain from baseline to 12 weeks after initiating the treatment.
Time frame: 0, 4, 8 and 12 weeks
Change in SPADI function from baseline to 12 weeks after initiating the treatment.
Time frame: 0, 4, 8 and 12 weeks
SPADI clinical response.
Time frame: 12 weeks (follow-up)
Global Perceived Effect (GPE) measured at 4, 8 and 12 weeks after initiating the treatment.
Time frame: 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.
Time frame: 0 and 12 weeks
Change in Passive Range Of Motion (P-ROM) in the affected shoulder from baseline to 12 weeks after initiating the treatment.
Time frame: 0 and 12 weeks
Number of treatments received due to shoulder symptoms from baseline to 12 weeks after initiating the treatment.
Time frame: 12 weeks (follow up)
Change in maximum shoulder pain intensity within the previous 24 hours in the affected shoulder measured by Numeric Rating Scale (NRS) from baseline to 12 weeks after initiating the treatment.
Time frame: 0, 4, 8 and 12 weeks
Change in shoulder pain during general activities within the previous 24 hours in the affected shoulder measured by Numeric Rating Scale (NRS) from baseline to 12 weeks after initiating the treatment.
Time frame: 0, 4, 8 and 12 weeks
Change in shoulder pain at rest within the previous 24 hours in the affected shoulder measured by Numeric Rating Scale (NRS) from baseline to 12 weeks after initiating the treatment.
Time frame: 0, 4, 8 and 12 weeks
Change in shoulder pain during sleep within the previous 24 hours in the affected shoulder measured by Numeric Rating Scale (NRS) from baseline to 12 weeks after initiating the treatment.
Time frame: 0, 4, 8 and 12 weeks
Change in shoulder pain assessment during flexion/rotation/abduction in the affected shoulder measured by Numeric Rating Scale (NRS) from baseline to 12 weeks after initiating the treatment.
Time frame: 0 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Derived from this study: PubMed 40105684Feder 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.
- Derived from this study: PubMed 35987857Feder 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.
- Individual participant dataSharing planned: Yes. Personal data for the primary and all secondary outcome measures will only be made available if required by the scientific journal, in which the result of the trial are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Gordon Ingwersen, PT, PhD principal investigator
Vejle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The expert assessment of shoulder impairments and individualised treatment plan and A minimal physiotherapeutic rehabilitation program delivered in a pamphlet in people with Shoulder Pain and Late Effect, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Shoulder Pain and Disability Index (SPADI) from baseline to 12 weeks after initiating the treatment. (time frame: 0, 4, 8 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05277909, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.