Dataset Information

The effects of myofascial induction therapy in survivors of head and neck cancer: a randomized, controlled clinical trial.

ABSTRACT:

Purpose

We aim to evaluate the effects of myofascial induction therapy (MIT) on the sequelae suffered by the survivors of HNC (sHNC).

Methods

We enrolled 46 sHNC in a randomized controlled trial (RCT), of whom 20 received a MIT protocol and 23 were placed on a waitlist while receiving the recommended treatment for 6 weeks. The MIT protocol included a total of 18 sessions, 3 days a week on alternate days for 6 weeks. Maximal mouth opening, the presence of temporomandibular dysfunction, cervical endurance, active range of motion (AROM), shoulder AROM, handgrip strength, and perceived physical fitness were assessed.

Results

Maximal mouth opening, temporomandibular dysfunction, cervical endurance, and AROM, affected shoulder abduction and unaffected shoulder flexion and external rotation significantly improved (p < .05) after an MIT protocol, but only cervical AROM and affected shoulder abduction changes were clinically meaningful. No statistically significant changes were observed in the other shoulder AROM, handgrip strength, or physical fitness perception (p > .05).

Conclusion

A 6-week MIT protocol improves mouth opening, TMD, cervical function (endurance and AROM), affected shoulder abduction and unaffected shoulder flexion, and external rotation AROM in the sHNC. However, no changes were observed in most of the shoulder AROM, muscular strength, or perceived physical fitness. Future studies should perform longer follow-up designs, increase the sample size, and include multimodal treatments to address these sequelae in the sHNC.

SUBMITTER: Ortiz-Comino L

PROVIDER: S-EPMC9758021 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

The effects of myofascial induction therapy in survivors of head and neck cancer: a randomized, controlled clinical trial.

Ortiz-Comino Lucía L Martín-Martín Lydia L Galiano-Castillo Noelia N Castro-Martín Eduardo E Fernández-Gualda Miguel Ángel MÁ Lozano-Lozano Mario M Fernández-Lao Carolina C

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 20221217 1

<h4>Purpose</h4>We aim to evaluate the effects of myofascial induction therapy (MIT) on the sequelae suffered by the survivors of HNC (sHNC).<h4>Methods</h4>We enrolled 46 sHNC in a randomized controlled trial (RCT), of whom 20 received a MIT protocol and 23 were placed on a waitlist while receiving the recommended treatment for 6 weeks. The MIT protocol included a total of 18 sessions, 3 days a week on alternate days for 6 weeks. Maximal mouth opening, the presence of temporomandibular dysfunct ...[more]

PMID: 36526871

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Project description:BACKGROUND:Head and neck cancer (HNC) patients are at high risk for developing lymphedema and fibrosis (LEF) following cancer treatment. Once HNC patients develop LEF, they need to conduct life-long self-care to slow LEF progression and reduce associated symptom burden and functional deficits. Data demonstrate that inadequate LEF self-care may be a potentially remediable issue. The objective of this study is to explore the feasibility and preliminary efficacy of an Information-Motivation-Behavioral (IMB) Skills model-driven self-care program (SCP) to improve LEF management and reduce LEF-related symptom burden and functional impairments. METHODS/DESIGN:This is a three-arm, prospective, randomized controlled clinical trial to compare: Group 1 - Usual Care, Group 2 - Usual Care Plus LEF-SCP, and Group 3 - Usual Care Plus LEF-SCP Plus Follow-Up. Participants will be HNC survivors aged > 18 years of age, who meet predefined inclusion and exclusion criteria. A sample size of 75 participants is targeted. Interventions will be provided by trained staff. The study assessments for all groups will take place at five points: study entry then 3, 6, 9, and 12 months post enrollment. Outcome measures include: (1) feasibility (barriers to implementation, safety, and satisfaction) of the proposed intervention; (2) self-efficacy and adherence to self-care; and (3) preliminary efficacy (LEF progression, symptom burden, and functional status) of the proposed intervention. DISCUSSION:This will be the first study to evaluate the feasibility of a LEF-SCP in the HNC population and its impact on self-efficacy and adherence. Furthermore, it will evaluate the potential benefit of routine follow-up on adherence and fidelity to the self-care protocol. We expect that the trial will provide evidence supporting the feasibility of a LEF self-care program. In addition, we anticipate that preliminary data will support improved outcomes including increased adherence and fidelity, and decreased LEF-associated symptoms. TRIAL REGISTRATION:ClinicalTrials.gov, a service of the US National Institute of Health (NCT03030859). Registered on 22 January 2017.

Project description:IntroductionDysphagia is common in head and neck cancer patients after concurrent chemoradiation therapy (CRT). This study evaluated the feasibility of conducting a randomized sham-controlled trial and collected preliminary data on safety and efficacy of acupuncture.Patients and methodsHead and neck cancer (HNC) patients with stage III-IV squamous cell carcinoma were randomized to 12 sessions of either active acupuncture (AA) or sham acupuncture (SA) during and following CRT. Patients were blinded to treatment assignment. Swallowing-related quality of life (QOL) was assessed using the MD Anderson Dysphagia Inventory (MDADI) total and subscale scores.ResultsMultiple aspects of trial feasibility were confirmed. Forty-two of 196 patients screened (21%) were enrolled and randomized to receive AA (n = 21) or SA (n = 21); 79% completed at least 10 of 12 planned acupuncture sessions; 81% completed the study follow-ups. The majority of patients reported uncertainty regarding their treatment assignment, with no difference between the AA and SA groups. Audits confirmed both AA and SA treatments were delivered with high fidelity. No serious acupuncture-related side effects were observed. MDADI total scores significantly improved from baseline to 12 months post-CRT in both groups (AA: +7.9; SA +13.9; p = .044, p < .001). Similar patterns were observed for the MDADI global subscale (AA: +25.0; SA +22.7; p = .001, p = .002). Intent-to-treat analyses suggested no difference between the treatment groups (p = .17, p = .76 for MDADI total and global scores, respectively).ConclusionA sham-controlled randomized trial evaluating acupuncture in dysphagia-related QOL in HNC found the procedure to be feasible and safe. Further investigation is required to evaluate efficacy.Implications for practiceDysphagia or swallowing difficulty is an important and common condition after concurrent chemoradiation therapy in head and neck cancer patients. In addition to current available supportive care, acupuncture may offer potential for treating dysphagia. This study demonstrated that both active acupuncture and sham acupuncture are safe and were associated with improved dysphagia-related quality of life from baseline to 12 months after concurrent chemoradiation therapy. This study was not designed to inform underlying specific versus nonspecific effects. Future larger-scale pragmatic clinical trials evaluating the effectiveness of acupuncture versus standard of care are warranted, and further mechanistic research is needed to understand how active versus purportedly sham acupuncture procedures affect dysphagia-related symptoms.

Dataset Information

The effects of myofascial induction therapy in survivors of head and neck cancer: a randomized, controlled clinical trial.

Purpose

Methods

Results

Conclusion

Publications

The effects of myofascial induction therapy in survivors of head and neck cancer: a randomized, controlled clinical trial.

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