Myofascial Versus Conventional Physiotherapy

NCT04369079 | Completed

• 1 other identifier: MYONAMASTE
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Sports; Therapy

Keywords

physiotherapy; Myofascial; post-mastectomy patients

Outcome Measures

Primary Outcomes (1)

• muscle length

  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 \[Page et al. 2010\].

  2 years

Secondary Outcomes (5)

• Active ROM in the shoulder joint on the surgical side

  2 years

• pathological response

  2 years

• Pain intensity

  2 years

• Scar mobility

  2 years

• Presence of the visual dysfunction of scar (retraction) and presence of the axillary web syndrome

  2 years

Study Arms (2)

TREATMENT GROUP

EXPERIMENTAL

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

CONTROL GROUP

OTHER

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.

Interventions

manual myofascial techniques OTHER

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.

TREATMENT GROUP

conventional therapy consisting of exercise and massage. OTHER

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.

CONTROL GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Greater Poland Cancer Centre: lead

Study Sites (1)

Greater Poland Cancer Centre

Poznan, Wielkopolska, 61-866, Poland

Location

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Sławomir Marszałek, PhD

  Greater Poland Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: January 1, 2013
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2014
• Last Updated: September 2, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)