Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Myofascial Versus Conventional Physiotherapy (MYONAMASTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369079
Recruitment Status : Completed
First Posted : April 30, 2020
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
The Greater Poland Cancer Centre

Brief Summary:

A total of 61 patients who underwent total mastectomy for breast cancer with axillar lymph dissection and adjuvant radiotherapy were enrolled in this trial.

The patients were randomized by toss of a coin to the treatment (n=30) or control (n=26) groups; of these, 48 met all study protocol requirements, including the final assessment. Inclusion criteria were: presence of functional difficulties in the shoulder area and/or upper torso on the surgical side, and 2) eligibility for physiotherapy (determined by the treating physician). Patients with recurrent disease and/or inflammatory or acute ailments were excluded. All patients gave their informed consent to participate in the study.

The treatment group received myofascial treatment while patients in the control group received conventional therapy consisting of exercise and massage.


Condition or disease Intervention/treatment Phase
Sports Therapy Other: manual myofascial techniques Other: conventional therapy consisting of exercise and massage. Not Applicable

Detailed Description:

Treatment duration in both groups was a mean of 4 weeks. Therapy was performed daily excluding weekends and consisted of 45 minutes of individual work with an oncological physiotherapist. In the treatment group, manual myofascial techniques were used to decrease muscle tension and increase elasticity of the soft tissues in the surgical area as well as in tissues that could affect range of motion (ROM) and cause pain. Fascial techniques were used together with the following techniques: deep massage of neck and shoulder girdle muscles; trigger point therapy; tissue scar treatment in the vicinity of the scar and directly on the scar, by stretching, breaking, pulling, as well as static and dynamic rolling; post-isometric relaxation (stretching) of shoulder and neck muscles; active release technique of the chest and shoulder; selected fascial distortion model techniques; and fascial manipulation techniques consisting of developing specific CC-center of coordination and CF-center of fusion points in the operated area and the shoulder on the same side. The exact sequence and number of procedures differed in each patient according to need as determined by prior functional examination. The control group underwent kinesiotherapeutic procedures that included various floor gymnastic exercises with gymnastic stick, balls, and/or elastic tapes, conventional massage of neck and shoulder girdle muscles and therapeutic exercises to increase ROM in the upper limb and in the chest area. Both groups before or after every of the treatment procedure underwent ten-minute manual lymphatic drainage in the limb on the mastectomy side.

Patient interviews and diagnostic examinations were performed at baseline (pre-treatment) and after treatment finalization. The following variables were assessed during the diagnostic examination of the muscle length with Janda's protocol:

Pectoralis Major - pars clavicularis - the normal length of these fibers allows the patient's arm (in an extended position close to the body) to rest below the horizontal.

Pectoralis Major - pars sternocostalis - the normal length of these fibers allows the abducted the patient's arm to 90° to rest below the horizontal.

Pectoralis Major - pars abdomen - the normal length of these pectoral fibers allows the abducted the patient's arm to 150° with slight external rotation to rest in a horizontal position.

Latissimus dorsi - the normal length allows the arm to rest horizontally to the table with the lumbar spine flat on the table.

Descending part of trapezius - the length is assessed qualitatively by noting the end-feel resistance. The normal end feel is gradual rather than abrupt.

Levator scapulae - the length is assessed qualitatively by noting the end-feel resistance. The normal end feel is gradual rather than abrupt.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

A total of 61 patients who underwent total mastectomy for breast cancer with axillar lymph dissection and adjuvant radiotherapy were enrolled in this trial.

The patients were randomized by toss of a coin to the treatment (n=30) or control (n=26) groups; of these, 48 met all study protocol requirements, including the final assessment. Inclusion criteria were: presence of functional difficulties in the shoulder area and/or upper torso on the surgical side, and 2) eligibility for physiotherapy (determined by the treating physician). Patients with recurrent disease and/or inflammatory or acute ailments were excluded. All patients gave their informed consent to participate in the study.

The treatment group received myofascial treatment while patients in the control group received conventional therapy consisting of exercise and massage.

Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Myofascial Versus Conventional Physiotherapy in Post-mastectomy Patients: a Randomized Controlled Trial
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : December 31, 2014
Actual Study Completion Date : December 31, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Experimental: TREATMENT GROUP
Fascial techniques were used together with the following techniques: deep massage of neck and shoulder girdle muscles; trigger point therapy; tissue scar treatment in the vicinity of the scar and directly on the scar, by stretching, breaking, pulling, as well as static and dynamic rolling; post-isometric relaxation (stretching) of shoulder and neck muscles; active release technique of the chest and shoulder; selected fascial distortion model techniques; and fascial manipulation techniques consisting of developing specific CC-center of coordination and CF-center of fusion points in the operated area and the shoulder on the same side. The exact sequence and number of procedures differed in each patient according to need as determined by prior functional examination. Before or after every of the treatment procedure treatment group patients underwent ten-minute manual lymphatic drainage in the limb on the mastectomy side.
Other: manual myofascial techniques
Fascial techniques were used together with the following techniques: deep massage of neck and shoulder girdle muscles; trigger point therapy; tissue scar treatment in the vicinity of the scar and directly on the scar, by stretching, breaking, pulling, as well as static and dynamic rolling; post-isometric relaxation (stretching) of shoulder and neck muscles; active release technique of the chest and shoulder; selected fascial distortion model techniques; and fascial manipulation techniques consisting of developing specific CC-center of coordination and CF-center of fusion points in the operated area and the shoulder on the same side.

CONTROL GROUP
Treatment duration was a mean of 4 weeks. Therapy was performed daily excluding weekends and consisted of 45 minutes of individual work with an oncological physiotherapist. The control group underwent kinesiotherapeutic procedures that included various floor gymnastic exercises with gymnastic stick, balls, and/or elastic tapes, conventional massage of neck and shoulder girdle muscles and therapeutic exercises to increase ROM in the upper limb and in the chest area. Before or after every of the treatment procedure control group patients underwent ten-minute manual lymphatic drainage in the limb on the mastectomy side.
Other: conventional therapy consisting of exercise and massage.
Underwent kinesiotherapeutic procedures that included various floor gymnastic exercises with gymnastic stick, balls, and/or elastic tapes, conventional massage of neck and shoulder girdle muscles and therapeutic exercises to increase ROM in the upper limb and in the chest area.




Primary Outcome Measures :
  1. muscle length [ Time Frame: 2 years ]

    muscle length with Janda's protocol

    Pectoralis Major - pars clavicularis - the normal length of these fibers allows the patient's arm (in an extended position close to the body) to rest below the horizontal.

    Pectoralis Major - pars sternocostalis - the normal length of these fibers allows the abducted the patient's arm to 90° to rest below the horizontal.

    Pectoralis Major - pars abdomen - the normal length of these pectoral fibers allows the abducted the patient's arm to 150° with slight external rotation to rest in a horizontal position.

    Latissimus dorsi - the normal length allows the arm to rest horizontally to the table with the lumbar spine flat on the table.

    Descending part of trapezius - the length is assessed qualitatively by noting the end-feel resistance. The normal end feel is gradual rather than abrupt.

    Levator scapulae - the length is assessed qualitatively by noting the end-feel resistance. The normal end feel is gradual rather than abrupt [Page et al. 2010].



Secondary Outcome Measures :
  1. Active ROM in the shoulder joint on the surgical side [ Time Frame: 2 years ]
    complete pathological response (pCR, pathologic Complete Response)

  2. pathological response [ Time Frame: 2 years ]
    ROM of the shoulder joint on the surgical side (flexion; extension; abduction; internal rotation; external rotation in horizontal flexion

  3. Pain intensity [ Time Frame: 2 years ]
    VAS - A tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain imaginable (10) . A patient marks a point ( 0 to 10) on the line that matches the amount of pain she feels."

  4. Scar mobility [ Time Frame: 2 years ]
    Made by the centimeter measure as difference of distance from the bone point, to the most limited place in the scar. It was measured in directions: cranial (distance from the ridge of the coracoid) and in the transverse direction (the distance from the xiphoidal process). The centimeter measure was the distance from the bone point (xiphoid process and coracoid), to the most limited place in the scar (which was marked on the patient's examination card so that the measurement could be repeated to the same place

  5. Presence of the visual dysfunction of scar (retraction) and presence of the axillary web syndrome [ Time Frame: 2 years ]
    Was observed presence of the visual dysfunction of scar (retraction) and presence of the axillary web syndrome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presence of functional difficulties in the shoulder area and/or upper torso on the surgical side
  • eligibility for physiotherapy (determined by the treating physician)
  • signed informed consent to participate in the study.

Exclusion Criteria:

  • patients with recurrent disease and/or inflammatory or acute ailments were excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369079


Locations
Layout table for location information
Poland
Greater Poland Cancer Centre
Poznań, Wielkopolska, Poland, 61-866
Sponsors and Collaborators
The Greater Poland Cancer Centre
Investigators
Layout table for investigator information
Principal Investigator: Sławomir Marszałek, PhD Greater Poland Cancer Centre
Layout table for additonal information
Responsible Party: The Greater Poland Cancer Centre
ClinicalTrials.gov Identifier: NCT04369079    
Other Study ID Numbers: MYONAMASTE
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Greater Poland Cancer Centre:
physiotherapy
Myofascial
post-mastectomy patients