Clinical trial NCT04369079: Myofascial Versus Conventional Physiotherapy
Official title: Myofascial Versus Conventional Physiotherapy in Post-mastectomy Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports
Therapy
Keywords: physiotherapy
Myofascial
post-mastectomy patients
Lead sponsor: The Greater Poland Cancer Centre
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: muscle length
timeFrame: 2 years
Secondary outcomes:
measure: Active ROM in the shoulder joint on the surgical side
timeFrame: 2 years
measure: pathological response
timeFrame: 2 years
measure: Pain intensity
timeFrame: 2 years
measure: Scar mobility
timeFrame: 2 years
measure: Presence of the visual dysfunction of scar (retraction) and presence of the axillary web syndrome
timeFrame: 2 years
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Greater Poland Cancer Centre
state: Wielkopolska
Study officials:
affiliation: Greater Poland Cancer Centre
name: Sławomir Marszałek, PhD
role: PRINCIPAL_INVESTIGATOR
References: