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Rehabilitation of shoulder dysfunctions using the Pilates method in patients with head and neck cancer undergoing neck dissection

Rehabilitation of shoulder dysfunctions using the Pilates method in patients with head and neck cancer undergoing neck dissection with preservation of the accessory nerve: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10yj9xdv
Enrollment
Unknown
Registered
2025-01-07
Start date
2022-01-31
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Neoplasms

Interventions

This is a single-blind randomized clinical study. Participants were randomly distributed into two groups (Control and Intervention) through a simple randomization process. The random sequence was prod
E02.760.169.063.500.387

Sponsors

Fundação Cristiano Varella
Lead Sponsor
Unifaminas
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients of both sexes; over 18 years old; with a primary diagnosis of head and neck cancer; who underwent neck dissection with preservation of the accessory nerve; whether or not they have undergone radiotherapy and/or chemotherapy treatment; who have limited range of motion of the shoulder on the surgery side ranging from 50° to 149° for flexion and abduction movements; that are in the acute phase, that is, evaluated within a maximum period of up to 45 days from the date of surgery

Exclusion criteria

Exclusion criteria: Patients undergoing neck dissection where there is a need to perform complete resection of the accessory nerve; who have had previous surgery and/or radiotherapy for head and neck cancer; with shoulder dysfunction already established before the surgical procedure; who have received any physiotherapeutic care with the aim of restoring range of movement; who have a range of motion limited to less than or equal to 49° for shoulder flexion and abduction movements or greater than 149°; who have cognitive impairment or any other impairment that prevents them from performing and understanding the proposed exercises; who underwent bilateral surgery and as a result have a range of movement for flexion and abduction of less than 150° in both upper limbs; those who refused to participate in the study; those who refused to sign the Free and Informed Consent Form after being informed

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: It is expected to quantify the number of Pilates sessions necessary to achieve an active range of motion equal to or greater than 150º of flexion and abduction of the shoulder ipsilateral to cervical lymphadenectomy, assessed through goniometry immediately after each session;Expected outcome 2: It is expected to quantify the number of conventional physiotherapy sessions necessary to achieve an active range of motion equal to or greater than 150º of flexion and abduction of the shoulder ipsilateral to cervical lymphadenectomy, assessed through goniometry immediately after each session ;Outcome found 1: The Intervention group (Pilates) performed, on average, 9.78 sessions to achieve an active range of movement equal to or greater than 150º of flexion and abduction of the shoulder ipsilateral to cervical lymphadenectomy;Outcome found 2: The control group (conventional physiotherapy) performed, on average, 10 sessions to achieve an active range of movement equal to or greater than 150º of flexion and abduction of the shoulder ipsilateral to cervical lymphadenectomy

Secondary

MeasureTime frame
Expected outcome 1: Improvement in muscle strength of the upper, middle and lower trapezius, assessed through manual muscle testing of the upper trapezius, middle trapezius and lower trapezius muscles, using the Oxford MRC strength scale graduated from 0 to 5;Outcome found 1: During the reassessment after therapeutic interventions in the control group and experimental group, improvements in upper trapezius muscle strength were observed in both groups (grade 4 - complete joint movement against gravity and some resistance). And comparing both groups after the interventions, no significant difference was observed in the reassessment between Control and Experimental for muscle strength measurements.;Expected outcome 2: Improvement in shoulder functionality for reaching objects, assessed using the International Classification of Functioning (ICF) classified as no disability, mild disability, moderate disability or severe disability;Outcome found 2: In the initial assessment, 81.8% of patients in the control group reported moderate disability and the Intervention group reported 66.7% for moderate disability. Upon reassessment, a slight deficiency was observed in the control group with 45.5% and the experimental group with 77.8%. Both groups had an improvement in the function of reaching objects, but comparing the experimental group with the control group, the experimental group had a significant improvement;Expected outcome 3: Reduce shoulder pain, assessed using the visual analogue scale (VAS), the scale was presented as a straight, horizontal line, numbered from 0 to 10 and containing figures representing the facial expression of pain, appearing at the left end no pain and worst possible pain in the right extremity;Outcome found 3: There is an association between the assessments (Initial and Reassessment) and the Visual Pain Scale (p=0,0034), there is an absence of intense pain and a greater occurrence of mild pain on reassessment. However, there is no significant diff

Countries

Brazil

Contacts

Public ContactRhayssa Santos Campos

Fundação Cristiano Varella

rhayssaesposito@yahoo.com.br+55 (032) 988744465

Outcome results

None listed

Source: REBEC (via WHO ICTRP)