Shoulder PainNCT02735668
Physiotherapy in Women With Peripheral Persistent Pain Following Breast Cancer Treatment
A study testing Shoulder Conventional Exercises, Multimodal Physiotherapy and Scapular exercises in people with Shoulder Pain and Breast Cancer, run by University of Alcala at 1 site in Spain.
Trial summary
The aim of this study is to determine the effectiveness of a multimodal physiotherapy intervention including scapula exercises in addition to deep dry needling and neurodynamic techniques versus scapula exercises only versus conventional shoulder exercises on pain intensity, perceived disability, scapula muscle… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Shoulder Pain, Breast Cancer
- What is being tested?
- Shoulder Conventional Exercises, Multimodal Physiotherapy and Scapular exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2016to Apr 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with peripheral persistent pain following breast cancer treatment (surgery and/or radiotherapy and/or chemotherapy) with pain for at least 6 months.
- Women who do not present contraindications for physiotherapy (infection, metastasis, locoregional recurrence).
- Women who have read, understood and signed informed consent freely
Who cannot join
- Women treated with bilateral breast cancer.
- Women with shoulder pain episodes prior to breast cancer treatment.
- Women with predominant central sensitization pain identified by the Central Sensitization Inventory (> 40 points)
- Women with cognitive limitations to understand the information provided, instructions for treatment and consent to their participation in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.
Alcalá de Henares, Madrid, 28871
About this study
Official title: Is Multimodal Physiotherapy More Effective Than Exercise Alone in Women With Peripheral Persistent Pain Following Breast Cancer Treatment? A Single-blinded Randomized Clinical Trial
The aim of this study is to determine the effectiveness of a multimodal physiotherapy intervention including scapula exercises in addition to deep dry needling and neurodynamic techniques versus scapula exercises only versus conventional shoulder exercises on pain intensity, perceived disability, scapula muscle activity and health-related quality of life.
Read the detailed description
Introduction: chronic shoulder pain is a frequent consequence after breast cancer treatment with a reported prevalence of 25% to 60% and is commonly termed "Persistent Pain after Breast Cancer Treatment" (PPBCT). Frequently, PPBCT includes neuropathic pain due to damage of neural tissue during surgery. However, recent studies, consider that myofascial pain syndrome and heightened mechanosensitivity of neural tissue can be also present in this women. Although PPBCT is typically managed with pharmacological treatment,currently, physiotherapy is presented as an alternative method. Physiotherapy in relation to the shoulder, commonly, focuses its treatment with therapeutic exercise. In this sense, there is great controversy about which are the most appropriate exercises. Recent authors, bet for more precise and analytical exercises in relation with scapula and reject conventional exercises for the shoulder. Taking into account each of the sources of pain presented by these women and the benefits of therapeutic exercise, it would be interesting to study which approach of physiotherapy treatment would be more appropriate in these women.
Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the intervention group to which subjects were assigned. Participants will be randomly assigned to three groups:
An experimental group, where the participants will be treated with Multimodal Physiotherapy;
Another experimental group where will be realized Scapular Exercises only;
And a third group where will be done Shoulder Conventional Exercises.
Pre- intervention, immediate post-intervention, 3, and 6 months assessments will be made. The selection criteria will be: women with peripheral persistent pain following breast cancer treatment (surgery and/or radiotherapy and/or chemotherapy) with pain for at least 6 months. The participants must understand and sign freely Informed Consent.
Sample size: 30 women for each group.
Data Analysis: A descriptive analysis of all variables will be performed. It will be established for all cases a confidence level of 95% (p <0.05). The effectiveness will be assessed by comparing the experienced change of the three goups in outcome variables between physicaltherapy examinations.
- Conditions
- Shoulder Pain, Breast Cancer
- Being tested
- Shoulder Conventional Exercises, Multimodal Physiotherapy, Scapular exercises, Therapeutic Education
- Keywords
- Shoulder Pain, Pattern Motor, Physical Therapy Modalities, Breast Cancer Treatment
- 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.
Shoulder Conventional ExercisesOther
Also called Conventional physical therapy
The protocol consists in:
- Flexibility and Strengthening Exercises of the shoulder muscles conventionally performed in shoulder pathology treatment:
- Mobilisation Joint Exercises.
- Isometrics and Resisted Exercises (elastic bands).
Multimodal PhysiotherapyOther
Also called Specific physical therapy
The protocol consists in:
- Dry Needling in active myofascial trigger points related to shoulder joint (optimal hygiene and disinfection before and after needling). Special care in muscles located in the arm in women with axillary node dissection.
- If Upper Limb Neural Tension Test is positive, neurodynamic techniques will be included.
Scapular exercisesOther
Also called Specific physical therapy
The protocol consists in:
Scapula-focused exercises: based on evaluation of scapular dyskinesis and Kinetic Medial Rotation Test as well as inherent characteristics of each woman, individualized scapular exercises were prescribed based on a motor control approach with emphasis on obtaining a neutral scapular orientation.
Therapeutic EducationBehavioural
Also called Hygienic and behavioral advises
The protocol consists in:
Therapeutic Education about chronic shoulder pain using a slide show, anatomical models, providing information and analysis of real clinical cases.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder Conventional Exercises | Active comparator | The protocol consists in:
* Flexibility and Strengthening Exercises of the shoulder muscles conventionally performed in shoulder pathology treatment.
* Therapeutic Education about chronic shoulder pain.
The treatment duration is 1 day per week during 6 weeks. Receives: Other: Shoulder Conventional Exercises; Behavioral: Therapeutic Education |
| Multimodal Physiotherapy | Experimental | The protocol consists in:
* Dry Needling in active myofascial trigger points.
* Neurodynamic techniques.
* Scapular exercises.
* Therapeutic Education about chronic shoulder pain.
The treatment duration is 1 day per week during 6 weeks. Receives: Other: Multimodal Physiotherapy; Other: Scapular exercises; Behavioral: Therapeutic Education |
| Scapular exercises | Experimental | The protocol consists in:
* Scapular exercises
* Therapeutic Education about chronic shoulder pain.
The treatment duration is 1 day per week during 6 weeks. Receives: Other: Scapular exercises; Behavioral: Therapeutic Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Visual analogue scale (VAS).100 mm horizontal with pain descriptors marked "no pain" on the left side or "worst imaginable pain".
Measured: Change from baseline VAS at after 9 physical therapy sessions, 3 and 6 months after baseline assessments will be require
Secondary outcomes (5)
Pain and Disability
The questionnaire Shoulder Pain and Disability Index validated in Spanish, to measure the intensity and information on the characteristics of pain and the level of shoulder disability is used. This questionnaire contains a numerical scale from 0 to 10 to collect each answer.
Measured: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
Root-Mean-Square (RMS) EMG Amplitude
Quantification of motor unit recruitment (electrical activity), by analyzing the RMS, expressed in microvolts (normalized data expressed as a percentage) of the muscles: upper and lower trapezius, middle deltoid, infraspinatus and serratus anterior during Abduction Movement
Measured: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
Onset EMG
Beginning of motor activation, expressed in seconds (s), of the muscles: upper and lower trapezius, middle deltoid, infraspinatus and serratus anterior during Abduction Movement.
Measured: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
Health-related quality of life
Questionnaire: Assessment of Cancer Therapy-Breast (FACT-B) Spanish version 4
Measured: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
Myofascial Pain Syndrome. Active myofascial trigger points of the muscles involved in shoulder. Travell and Simon's Criteria were used.
Travell and Simon's Criteria consists in (Wolfe et al 1992):
The major criteria include:
- A patient's regional pain complaint;
- Palpation of a trigger point elicits a stereotypic zone of referred pain specific to that muscle;
- Identification of a palpable taut band;
- As well as a palpable, and exquisitely tender spot along the length of that taut band;
- Some degree of restricted range of motion of the involved muscle.
Three minor criteria have been suggested to further aid in the diagnosis of myofascial pain syndrome:
- Palpation of a trigger point should reproduce the clinical pain complaint;
- A local twitch response may be elicited by transverse snapping or needling of the trigger point;
- The alleviation of pain by trigger point inactivation.
Measured: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionFeb 2021
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginia Prieto Gómez, University of Alcala
- Investigators
- Virginia P Gómez, PhD Student, Principal investigator, Department of Physiotherapy. University of Alcala.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735668
- Sponsor's protocol ID
- FPSM_UAH_VPG
- Status last verified
- Mar 2026
- First submitted
- 3 Apr 2016
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Multimodal Physiotherapy More Effective Than Exercise Alone in Women With Peripheral Persistent Pain Following Breast Cancer Treatment? A Single-blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02735668
- Acronym / sponsor ID
- FPSM_UAH_VPG
- Conditions
- Shoulder Pain, Breast Cancer
- Keywords
- Shoulder Pain, Pattern Motor, Physical Therapy Modalities, Breast Cancer Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 13 Apr 2016 (estimated)
- 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.
The aim of this study is to determine the effectiveness of a multimodal physiotherapy intervention including scapula exercises in addition to deep dry needling and neurodynamic techniques versus scapula exercises only versus conventional shoulder exercises on pain intensity, perceived disability, scapula muscle activity and health-related quality of life.
Detailed description
Introduction: chronic shoulder pain is a frequent consequence after breast cancer treatment with a reported prevalence of 25% to 60% and is commonly termed "Persistent Pain after Breast Cancer Treatment" (PPBCT). Frequently, PPBCT includes neuropathic pain due to damage of neural tissue during surgery. However, recent studies, consider that myofascial pain syndrome and heightened mechanosensitivity of neural tissue can be also present in this women. Although PPBCT is typically managed with pharmacological treatment,currently, physiotherapy is presented as an alternative method. Physiotherapy in relation to the shoulder, commonly, focuses its treatment with therapeutic exercise. In this sense, there is great controversy about which are the most appropriate exercises. Recent authors, bet for more precise and analytical exercises in relation with scapula and reject conventional exercises for the shoulder. Taking into account each of the sources of pain presented by these women and the benefits of therapeutic exercise, it would be interesting to study which approach of physiotherapy treatment would be more appropriate in these women.
Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the intervention group to which subjects were assigned. Participants will be randomly assigned to three groups:
An experimental group, where the participants will be treated with Multimodal Physiotherapy;
Another experimental group where will be realized Scapular Exercises only;
And a third group where will be done Shoulder Conventional Exercises.
Pre- intervention, immediate post-intervention, 3, and 6 months assessments will be made. The selection criteria will be: women with peripheral persistent pain following breast cancer treatment (surgery and/or radiotherapy and/or chemotherapy) with pain for at least 6 months. The participants must understand and sign freely Informed Consent.
Sample size: 30 women for each group.
Data Analysis: A descriptive analysis of all variables will be performed. It will be established for all cases a confidence level of 95% (p <0.05). The effectiveness will be assessed by comparing the experienced change of the three goups in outcome variables between physicaltherapy examinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shoulder Conventional Exercises | Active comparator | Other: Shoulder Conventional Exercises, Behavioral: Therapeutic EducationThe protocol consists in: * Flexibility and Strengthening Exercises of the shoulder muscles conventionally performed in shoulder pathology treatment. * Therapeutic Education about chronic shoulder pain. The treatment duration is 1 day per week during 6 weeks. |
| Multimodal Physiotherapy | Experimental | Other: Multimodal Physiotherapy, Other: Scapular exercises, Behavioral: Therapeutic EducationThe protocol consists in: * Dry Needling in active myofascial trigger points. * Neurodynamic techniques. * Scapular exercises. * Therapeutic Education about chronic shoulder pain. The treatment duration is 1 day per week during 6 weeks. |
| Scapular exercises | Experimental | Other: Scapular exercises, Behavioral: Therapeutic EducationThe protocol consists in: * Scapular exercises * Therapeutic Education about chronic shoulder pain. The treatment duration is 1 day per week during 6 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women with peripheral persistent pain following breast cancer treatment (surgery and/or radiotherapy and/or chemotherapy) with pain for at least 6 months.
- Women who do not present contraindications for physiotherapy (infection, metastasis, locoregional recurrence).
- Women who have read, understood and signed informed consent freely
Key exclusion criteria (4 listed)
- Women treated with bilateral breast cancer.
- Women with shoulder pain episodes prior to breast cancer treatment.
- Women with predominant central sensitization pain identified by the Central Sensitization Inventory (> 40 points)
- Women with cognitive limitations to understand the information provided, instructions for treatment and consent to their participation in the study.
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 |
|---|---|---|
| Shoulder Conventional ExercisesAlso: Conventional physical therapyThe protocol consists in: • Flexibility and Strengthening Exercises of the shoulder muscles conventionally performed in shoulder pathology treatment: * Mobilisation Joint Exercises. * Isometrics and Resisted Exercises (elastic bands). | Other | Shoulder Conventional Exercises |
| Multimodal PhysiotherapyAlso: Specific physical therapyThe protocol consists in: * Dry Needling in active myofascial trigger points related to shoulder joint (optimal hygiene and disinfection before and after needling). Special care in muscles located in the arm in women with axillary node dissection. * If Upper Limb Neural Tension Test is positive, neurodynamic techniques will be included. | Other | Multimodal Physiotherapy |
| Scapular exercisesAlso: Specific physical therapyThe protocol consists in: Scapula-focused exercises: based on evaluation of scapular dyskinesis and Kinetic Medial Rotation Test as well as inherent characteristics of each woman, individualized scapular exercises were prescribed based on a motor control approach with emphasis on obtaining a neutral scapular orientation. | Other | Multimodal Physiotherapy, Scapular exercises |
| Therapeutic EducationAlso: Hygienic and behavioral advisesThe protocol consists in: Therapeutic Education about chronic shoulder pain using a slide show, anatomical models, providing information and analysis of real clinical cases. | Behavioural | Multimodal Physiotherapy, Scapular exercises, Shoulder Conventional Exercises |
Primary outcome
Pain Intensity
Time frame: Change from baseline VAS at after 9 physical therapy sessions, 3 and 6 months after baseline assessments will be require
Visual analogue scale (VAS).100 mm horizontal with pain descriptors marked "no pain" on the left side or "worst imaginable pain".
5 secondary outcomes
Pain and Disability
Time frame: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
Root-Mean-Square (RMS) EMG Amplitude
Time frame: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
Onset EMG
Time frame: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
Health-related quality of life
Time frame: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
Myofascial Pain Syndrome. Active myofascial trigger points of the muscles involved in shoulder. Travell and Simon's Criteria were used.
Time frame: At baseline, after 9 physical therapy sessions, 3 and 6 months after baseline assessments were required.
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 9 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Virginia P Gómez, PhD Student principal investigator
Department of Physiotherapy. University of Alcala.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder Conventional Exercises, Multimodal Physiotherapy and Scapular exercises in people with Shoulder Pain and Breast Cancer, run by University of Alcala at 1 site in Spain.
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 3 inclusion and 4 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 9 Mar 2026. 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 Spain. 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?
Pain Intensity (time frame: Change from baseline VAS at after 9 physical therapy sessions, 3 and 6 months after baseline assessments will be require). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2026.