跳至主要内容
临床试验/CTRI/2025/09/095404
CTRI/2025/09/095404尚未招募不适用

Impact of pre-radiation manual therapy on neck and shoulder dysfunction and quality of life in head and neck cancer survivors: A randomized control trial.

KLE Academy Higher Education and Research1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
1. Neck dysfunction

研究概览

简要总结

Surgical procedures in head and neck cancer, while necessary for tumour removal and reconstruction, can cause musculoskeletal impairments, including pain, restricted range of motion (ROM), and functional disability due to muscle dissection and altered biomechanics. A regimen of exercises and patient education is an effective tool to reduce shoulder disability and improve shoulder function. The study suggests that manual therapy techniques can alleviate neck pain and improve quality of life, and recommends their use in clinical settings, but caution should be exercised when selecting these techniques for head and neck cancer survivors. MWM is associated with improved pain, mobility, and function in patients with a range of shoulder musculoskeletal disorders, and the effects are clinically meaningful. Radiation to the neck can cause a woody texture and limited mobility of the neck, enhance lymphedema, significant tightness of the neck and shoulder muscles, including the scalenes, trapezius, and sternocleidomastoid muscles. Fibrosis may cause both cosmetic and functional impairment, leading to deterioration in the quality of life. Research suggests Pain reduction, Improvement in Cervical, TMJ, and shoulder range of motion, Improved Quality of life, and reduction in disability following a combined manual therapy approach in head and neck cancer patients post radiation. Although manual therapy is often used after surgery and radiation, its benefits when applied before radiation therapy have not been well studied, particularly for HNC patients with reconstructive flap surgeries. Applying manual therapy before radiation could be an effective way to manage dysfunction early in the recovery process, potentially preventing long-term problems caused by radiation. Given the lack of research on this approach, a randomized controlled trial (RCT) is needed to determine the effectiveness of pre-radiation manual therapy in reducing neck and shoulder dysfunction in HNC patients. Such a study could provide valuable evidence to develop evidence-based rehabilitation protocols that improve patient outcomes and reduce the need for intensive post-radiation interventions.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
25.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Head and neck cancer patients underwent PMMC or DP flap reconstruction.
  • Patients planned for radiation therapy post-intervention Scheduled for radiation therapy starting post-surgery.
  • Healed flap with no surgical complications.

排除标准

  • Severe cardiovascular, neurological, or musculoskeletal conditions that contraindicate manual therapy.
  • Patients with pre-existing severe shoulder and neck dysfunction.
  • Patients with advanced metastases Patients with secondary suturing.

结局指标

主要结局

1. Neck dysfunction

时间窗: 1. Neck disability index scale (NDI) | 2. Shoulder Pain and Disability Index (SPADI) | The following outcomes would be assessed at baseline (before 1st session, at the end of 10th session, and follow up (post radiation therapy)

2. Shoulder dysfunction

时间窗: 1. Neck disability index scale (NDI) | 2. Shoulder Pain and Disability Index (SPADI) | The following outcomes would be assessed at baseline (before 1st session, at the end of 10th session, and follow up (post radiation therapy)

次要结局

  • 1. Scapulohumeral Rhythm(2. Pain Levels)

研究者

发起方
KLE Academy Higher Education and Research
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Janhvi Jayesh Shah

KAHER Institute of Physiotherapy

研究点 (1)

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