Breast CarcinomaNCT05041751
Myofascial Release or Trigger Point Injections for the Reduction of Post-Mastectomy Pain Syndrome
A study testing Acupuncture Point Injection, Massage Therapy and Quality-of-Life Assessment in people with Breast Carcinoma, run by M.D. Anderson Cancer Center.
Trial summary
This clinical trial studies the effect of myofascial release in decreasing post-mastectomy pain compared to standard of care trigger point injections in patients with post-mastectomy pain syndrome. Patients who have mastectomies often experience pain that does not go away after time. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Acupuncture Point Injection, Massage Therapy and Quality-of-Life Assessment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 23 Mar 2022to 23 Mar 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic post-mastectomy pain syndrome (>= 3 months)
- Able to perform MFR techniques and follow basic instructions
- >= 18 years old
Who cannot join
- Current chemotherapy
- Pending surgery during treatment
- Active infection
- Active debilitating disease
- Pregnant
- Other chronic pain diagnosis beside PMPS
Show all 9Show fewer
- Untreated psychiatric diagnosis (not receptive to taking precautions and interventions by treating psychiatrist/psychologist/physician i.e. taking necessary medications)
- Morbid obesity (body mass index [BMI] > 40)
- Allergy history of bupivacaine and/or lidocaine
About this study
Official title: A Pilot Study Assessing the Benefits of Fascial Freedom for the Win (MFR Versus TPI)
This clinical trial studies the effect of myofascial release in decreasing post-mastectomy pain compared to standard of care trigger point injections in patients with post-mastectomy pain syndrome. Patients who have mastectomies often experience pain that does not go away after time. This is known as post-mastectomy pain syndrome. Myofascial release is a form of physical therapy in which pressure is applied to the affected areas. Myofascial release may be an effective way of decreasing pain in patients with post-mastectomy pain syndrome without the use of medication.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the change in pain score using the Numerical Rating Scale for pain on an 11-point scale (0-none to 10-worst) from implementation of myofascial release (MFR) versus trigger point injections (TPI) in the treatment of myofascial trigger points (MTP) as noninvasive therapies for post mastectomy pain syndrome (PMPS).
SECONDARY OBJECTIVES:
- To evaluate the change in medications, particularly opiate medications in the treatment of post mastectomy pain.
II. To evaluate a patient's satisfaction with therapy or treatment throughout the course of the study at each consecutive encounter or follow up.
III. To evaluate a patient's range of motion with therapy or treatment beginning at time of screening and until the end of the study.
IV. To evaluate a patient's degree of lymphedema both subjectively and objectively in the affected extremity(ies) unilateral to the site(s) of mastectomy in response to the various forms of treatment throughout the study.
- To evaluate quality of life measure changes with treatments used throughout the study.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care trigger point injections at baseline.
ARM II: Patients perform myofascial release for 10 minutes each day.
- Conditions
- Breast Carcinoma
- Being tested
- Acupuncture Point Injection, Massage Therapy, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture Point InjectionProcedure or surgery
Receive trigger point injections
Massage TherapyProcedure or surgery
Also called Massage
Perform myofascial release
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (trigger point injections) | Active comparator | Patients receive standard of care trigger point injections at baseline Receives: Procedure: Acupuncture Point Injection; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (myofascial release) | Experimental | Patients perform myofascial release for 10 minutes each day. Receives: Procedure: Massage Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain response
Defined by score differences (using the pain numerical rating scale). an 11-point scale (0-none to 10-worst) Pain responders will be defined as patients demonstrating an equal or lower pain score relative to baseline. The 2-week post-treatment assessment will be used to assess the primary endpoint.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start23 Mar 2022
- Primary completion23 Mar 2022
- Study completion23 Mar 2022
Why it stopped: PI Left Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Le-Short, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041751
- Sponsor's protocol ID
- 2020-0498
- Other IDs
- NCI-2020-13900, 2020-0498
- Status last verified
- May 2022
- First submitted
- 3 Feb 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing the Benefits of Fascial Freedom for the Win (MFR Versus TPI)
- ClinicalTrials.gov ID
- NCT05041751
- Acronym / sponsor ID
- 2020-0498
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI Left Institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 13 Sep 2021 (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.
This clinical trial studies the effect of myofascial release in decreasing post-mastectomy pain compared to standard of care trigger point injections in patients with post-mastectomy pain syndrome. Patients who have mastectomies often experience pain that does not go away after time. This is known as post-mastectomy pain syndrome. Myofascial release is a form of physical therapy in which pressure is applied to the affected areas. Myofascial release may be an effective way of decreasing pain in patients with post-mastectomy pain syndrome without the use of medication.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the change in pain score using the Numerical Rating Scale for pain on an 11-point scale (0-none to 10-worst) from implementation of myofascial release (MFR) versus trigger point injections (TPI) in the treatment of myofascial trigger points (MTP) as noninvasive therapies for post mastectomy pain syndrome (PMPS).
SECONDARY OBJECTIVES:
- To evaluate the change in medications, particularly opiate medications in the treatment of post mastectomy pain.
II. To evaluate a patient's satisfaction with therapy or treatment throughout the course of the study at each consecutive encounter or follow up.
III. To evaluate a patient's range of motion with therapy or treatment beginning at time of screening and until the end of the study.
IV. To evaluate a patient's degree of lymphedema both subjectively and objectively in the affected extremity(ies) unilateral to the site(s) of mastectomy in response to the various forms of treatment throughout the study.
- To evaluate quality of life measure changes with treatments used throughout the study.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care trigger point injections at baseline.
ARM II: Patients perform myofascial release for 10 minutes each day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (trigger point injections) | Active comparator | Procedure: Acupuncture Point Injection, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive standard of care trigger point injections at baseline |
| Arm II (myofascial release) | Experimental | Procedure: Massage Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients perform myofascial release for 10 minutes each day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic post-mastectomy pain syndrome (>= 3 months)
- Able to perform MFR techniques and follow basic instructions
- >= 18 years old
Key exclusion criteria (9 listed)
- Current chemotherapy
- Pending surgery during treatment
- Active infection
- Active debilitating disease
- Pregnant
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 |
|---|---|---|
| Acupuncture Point InjectionReceive trigger point injections | Procedure or surgery | Arm I (trigger point injections) |
| Massage TherapyAlso: MassagePerform myofascial release | Procedure or surgery | Arm II (myofascial release) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (trigger point injections), Arm II (myofascial release) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (trigger point injections), Arm II (myofascial release) |
Primary outcome
Pain response
Time frame: through study completion, an average of 1 year
Defined by score differences (using the pain numerical rating scale). an 11-point scale (0-none to 10-worst) Pain responders will be defined as patients demonstrating an equal or lower pain score relative to baseline. The 2-week post-treatment assessment will be used to assess the primary endpoint.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Christina Le-Short principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture Point Injection, Massage Therapy and Quality-of-Life Assessment in people with Breast Carcinoma, run by M.D. Anderson Cancer Center.
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 9 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: withdrawn, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 response (time frame: through study completion, an average of 1 year). 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 17 May 2022.