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临床试验/NCT07266623
NCT07266623尚未招募不适用

Effects of Muscle Energy Techniques With and Without Manual Axial Distraction on Pain, Range of Motion Anf Functional Outcomes in Post-Mastectomy Patients With Axillary Web Syndrome

Lahore University of Biological and Applied Sciences0 个研究点目标入组 58 人开始时间: 2025年12月13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
58
主要终点
Pain Intensity

研究概览

简要总结

This randomized controlled trial aims to evaluate the effects of muscle energy techniques with and without manual axial distraction among post-mastectomy patients with axillary web syndrome. Fifty-eight participants will be randomly allocated into two groups and will receive the interventions for six weeks. It is hypothesized that the group that will receive both the muscle energy technique and manual axial distraction will produce greater improvements compared to the other group that will receive only MET.

详细描述

Axillary web syndrome (AWS) is a common post-mastectomy complication characterized by painful, palpable cords that limit shoulder mobility and functional performance. Current rehabilitation approaches emphasize soft-tissue mobilization, stretching, and manual therapy, yet evidence regarding the combined application of muscle energy technique (MET) and manual axial distraction (MAD) remains limited. This randomized controlled trial is designed to compare the effectiveness of MET alone versus MET combined with MAD in improving pain, range of motion (ROM), cord resolution, and functional outcomes in women with AWS. Participants will be randomly assigned to one of two groups using a concealed allocation procedure. All participants will begin each session with a 10-minute heating pad application to promote tissue elasticity, followed by a standardized stretching protocol targeting shoulder flexion and abduction in both supine and sitting positions; each stretch will be repeated five times and held for 30 seconds. The intervention group will receive MET applied to the pectoralis major, supraspinatus, subscapularis, and latissimus dorsi muscles in addition to MAD. MET will be administered using approximately 20% isometric contraction effort without pain, held for 7-10 seconds, followed by therapist-assisted stretching to the new tissue barrier; this cycle will be repeated three times per muscle. Positioning will be adapted for each muscle based on anatomical considerations, such as supine positioning with arm abduction for pectoralis major and subscapularis, or seated positioning for supraspinatus. The MAD technique will be performed using sustained shoulder joint traction for 15-30 seconds combined with firm digital pressure along the fibrous cords until a palpable "snapping" sensation indicates cord release. The comparison group will receive the same stretching and MET protocol without MAD. All interventions will be delivered three times per week for six consecutive weeks, with each session lasting approximately 30-40 minutes and tailored to participant tolerance. Primary outcomes include pain (Numeric Rating Scale), shoulder ROM (goniometry). Secondary outcomes include functional outcome( DASH questionnaire) and cord visibility. Outcome assessments will be conducted at baseline and at six weeks by a blinded assessor. Statistical analysis will include normality testing followed by parametric (paired and independent t-tests, ANOVA) or non-parametric equivalents (Wilcoxon or Mann-Whitney U tests) as appropriate. Effect sizes will be calculated, and significance will be set at p < 0.05. The trial is designed to determine whether adding MAD to MET results in superior improvements in tissue extensibility, pain reduction, ROM enhancement, and functional recovery compared with MET alone, thereby providing evidence-based guidance for rehabilitation of post-mastectomy AWS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Due to the nature of the intervention, the blinding of participants and therapists was not feasible. To overcome the assessment bias, the outcome assessor remained blinded to group allocations, maintaining single blinded study design

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients diagnosed with AWS following breast cancer surgery
  • Females aged 30 to 60 years old
  • Participants must be within 1 month to 2 years post-surgery
  • Participants having limited shoulder ROM
  • Participants must have completed their post-surgery radiation therapy and chemotherapy minimum of 2-3 weeks

排除标准

  • Any previous history of shoulder pathology
  • Patients with a cervical problem that radiates pain down the shoulder
  • Pregnant females
  • Bilateral mastectomy
  • Ongoing cancer stage
  • Participants with ongoing chemotherapy
  • Frozen shoulder

结局指标

主要结局

Pain Intensity

时间窗: Baseline: Before intervention 6 weeks post-intervention

Participants will be asked to rate the pain by using an outcome measure tool, NPRS, a numeric pain rating scale that ranges from 0 to 10. O means no pain, 1-3 means mild pain, 4-6 means moderate pain, 7-10 means severe pain.

Shoulder Range of Motion

时间窗: Baseline: Before intervention 6 weeks post-intervention

Shoulder range of motion of the affected side will be measured by using an outcome measure tool, goniometry. Shoulder flexion and abduction ranges will be assessed in the sitting position. Each movement will be performed thrice, and the average values will be analyzed accordingly.

次要结局

  • Functional Outcomes(Baseline: Before intervention 6 weeks post-intervention)

研究者

发起方
Lahore University of Biological and Applied Sciences
申办方类型
Other
责任方
Sponsor

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