PainNCT02859168
Myofascial Induction in Breast Cancer Survivors
A study testing Myofascial Induction and Unplugged pulsed shortwave therapy in people with Pain and Breast Cancer, run by Universidad de Granada at 1 site in Spain.
Trial summary
The purpose of this study was to show the immediate effects of myofascial induction on perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast cancer survivors suffering shoulder/arm morbidity. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Pain, Breast Cancer
- What is being tested?
- Myofascial Induction and Unplugged pulsed shortwave therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2014to Oct 2017
- 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- had a diagnosis of breast cancer (cancer stage I-IIIA)
- was between the ages of 25 and 65
- had completed adjuvant therapy except hormonal treatment
Who cannot join
- had cancer recurrence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Single-blind, Placebo-controlled Cross-over Design of Myofascial Induction and Placebo Electrotherapy in Breast Cancer Survivors
The purpose of this study was to show the immediate effects of myofascial induction on perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast cancer survivors suffering shoulder/arm morbidity.
Read the detailed description
Background: To investigate the immediate effects of myofascial induction on perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast cancer survivors suffering shoulder/arm morbidity.
Methods: Randomized, single-blind, placebo-controlled cross-over study. Twenty-one enrolled participants who had a diagnosis of breast cancer stage I-IIIA and had completed adjuvant therapy except hormonal treatment. The study consisted of two intervention sessions of 30 minutes separated by a wash-up period of 4 weeks. The interventions consisted of a Myofascial Induction (experimental group) or placebo pulsed shortwave therapy (control group). The main outcome measures were: Visual Analogue Scale for pain and anxiety, shoulder-cervical goniometry for range of motion, Profile of Mood States for psychological distress and Attitudes Toward Massage Scale.
- Conditions
- Pain, Breast Cancer
- Being tested
- Myofascial Induction, Unplugged pulsed shortwave therapy
- Keywords
- Neck, Shoulder, Manual Therapies
- Medical subject headings
- Pain, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial InductionBehavioural
Patients received a Myofascial Induction focused on the upper limb area for 30 minutes using the Pilat approach.
Unplugged pulsed shortwave therapyDevice
Patients received a placebo session consisted of 30 minutes of unplugged pulsed shortwave therapy.
| Study group | Role | What they receive |
|---|---|---|
| Myofascial Induction session | Experimental | Patients received a Myofascial Induction focused on the upper limb area for 30 minutes using the Pilat approach. Receives: Behavioral: Myofascial Induction |
| Placebo session | Placebo comparator | Patients received a placebo session consisted of 30 minutes of unplugged pulsed shortwave therapy. Receives: Device: Unplugged pulsed shortwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS). Change scores
A numerical rating scale that contains scores in the range of 0 to 10 (0 = 'no pain/anxiety'; 10 = 'worst imaginable pain/anxiety level'). Participants must mark the level of pain that they feel at that moment in the cervical-arm area and use the scale to indicate their anxiety level.
Measured: A wash-up period of 4 weeks between the 2 sessions was established
Secondary outcomes (4)
Goniometry shoulder. Change scores
A plastic universal goniometer with two adjustable overlapping arms to measure the active range of motion of the shoulder joint.
Measured: A wash-up period of 4 weeks between the 2 sessions was established
Goniometry cervical. Change scores
A cervical goniometric device manufactured by Performance Attainment Associates (St Paul, MN, USA) to measure the active range of motion of the cervical joints.
Measured: A wash-up period of 4 weeks between the 2 sessions was established
Profile of Mood States (POMS). Change scores
This questionnaire is a measure of psychological distress. This questionnaire contains 65 items assessing mood state, which are grouped into six subscales: tension-anxiety, depression-dejection, anger-hostility, vigour-activity, fatigue-inertia and confusion-bewilderment.
Measured: A wash-up period of 4 weeks between the 2 sessions was established
Attitudes toward massage (ATOM) scale
The Attitudes toward massage (ATOM) scale is a nine-item measure of overall attitude toward massage composed of the 'Massage as Healthful' and the 'Massage as Pleasant' subscales.
Measured: Covariates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startJun 2014
- Primary completionAug 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Arroyo Morales, Universidad de Granada
- Investigators
- Manuel Arroyo-Morales, PhD, Principal investigator, Deparment of Physical Therapy, Faculty of Health Sciences, University of Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859168
- Sponsor's protocol ID
- FIS PI10/02749-02764
- Status last verified
- Oct 2021
- First submitted
- 1 Aug 2016
- Last updated
- 18 Oct 2021
- Results posted
- No
Publications
Castro-Martin E, Ortiz-Comino L, Gallart-Aragon T, Esteban-Moreno B, Arroyo-Morales M, Galiano-Castillo N. Myofascial Induction Effects on Neck-Shoulder Pain in Breast Cancer Survivors: Randomized, Single-Blind, Placebo-Controlled Crossover Design. Arch Phys Med Rehabil. 2017 May;98(5):832-840. doi: 10.1016/j.apmr.2016.11.019. Epub 2016 Dec 18.
PubMed 28003133
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-blind, Placebo-controlled Cross-over Design of Myofascial Induction and Placebo Electrotherapy in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02859168
- Acronym / sponsor ID
- FIS PI10/02749-02764
- Conditions
- Pain, Breast Cancer
- Keywords
- Neck, Shoulder, Manual Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 8 Aug 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 purpose of this study was to show the immediate effects of myofascial induction on perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast cancer survivors suffering shoulder/arm morbidity.
Detailed description
Background: To investigate the immediate effects of myofascial induction on perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast cancer survivors suffering shoulder/arm morbidity.
Methods: Randomized, single-blind, placebo-controlled cross-over study. Twenty-one enrolled participants who had a diagnosis of breast cancer stage I-IIIA and had completed adjuvant therapy except hormonal treatment. The study consisted of two intervention sessions of 30 minutes separated by a wash-up period of 4 weeks. The interventions consisted of a Myofascial Induction (experimental group) or placebo pulsed shortwave therapy (control group). The main outcome measures were: Visual Analogue Scale for pain and anxiety, shoulder-cervical goniometry for range of motion, Profile of Mood States for psychological distress and Attitudes Toward Massage Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofascial Induction session | Experimental | Behavioral: Myofascial InductionPatients received a Myofascial Induction focused on the upper limb area for 30 minutes using the Pilat approach. |
| Placebo session | Placebo comparator | Device: Unplugged pulsed shortwave therapyPatients received a placebo session consisted of 30 minutes of unplugged pulsed shortwave therapy. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- had a diagnosis of breast cancer (cancer stage I-IIIA)
- was between the ages of 25 and 65
- had completed adjuvant therapy except hormonal treatment
Key exclusion criteria (1 listed)
- had cancer recurrence
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 |
|---|---|---|
| Myofascial InductionPatients received a Myofascial Induction focused on the upper limb area for 30 minutes using the Pilat approach. | Behavioural | Myofascial Induction session |
| Unplugged pulsed shortwave therapyPatients received a placebo session consisted of 30 minutes of unplugged pulsed shortwave therapy. | Device | Placebo session |
Primary outcome
Visual Analogue Scale (VAS). Change scores
Time frame: A wash-up period of 4 weeks between the 2 sessions was established
A numerical rating scale that contains scores in the range of 0 to 10 (0 = 'no pain/anxiety'; 10 = 'worst imaginable pain/anxiety level'). Participants must mark the level of pain that they feel at that moment in the cervical-arm area and use the scale to indicate their anxiety level.
4 secondary outcomes
Goniometry shoulder. Change scores
Time frame: A wash-up period of 4 weeks between the 2 sessions was established
Goniometry cervical. Change scores
Time frame: A wash-up period of 4 weeks between the 2 sessions was established
Profile of Mood States (POMS). Change scores
Time frame: A wash-up period of 4 weeks between the 2 sessions was established
Attitudes toward massage (ATOM) scale
Time frame: Covariates
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 18 Oct 2021.
- Results publication: PubMed 28003133Castro-Martin E, Ortiz-Comino L, Gallart-Aragon T, Esteban-Moreno B, Arroyo-Morales M, Galiano-Castillo N. Myofascial Induction Effects on Neck-Shoulder Pain in Breast Cancer Survivors: Randomized, Single-Blind, Placebo-Controlled Crossover Design. Arch Phys Med Rehabil. 2017 May;98(5):832-840. doi: 10.1016/j.apmr.2016.11.019. Epub 2016 Dec 18.
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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.
Manuel Arroyo-Morales, PhD principal investigator
Deparment of Physical Therapy, Faculty of Health Sciences, University of Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial Induction and Unplugged pulsed shortwave therapy in people with Pain and Breast Cancer, run by Universidad de Granada 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 1 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 18 Oct 2021. 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. Some participants in this study may receive a placebo. 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?
Visual Analogue Scale (VAS). Change scores (time frame: A wash-up period of 4 weeks between the 2 sessions was established). 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 NCT02859168, which also lists 1 linked publication.
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 18 Oct 2021.