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临床试验/CTRI/2025/04/084722
CTRI/2025/04/084722尚未招募不适用

Study the effect of spinal manipulation on biopsychosocial health aspects in forward shoulder posture

AIIMS NEW DELHI1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年4月15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
46
试验地点
1
主要终点
Pain

研究概览

简要总结

This study aims to evaluate the impact of spinal manipulation on biopsychosocial health factors in individuals with forward shoulder posture. The primary objective is to assess improvements in physical aspects such as posture and pain, while also examining psychological factors like anxiety and depression, and social aspects like daily functioning and quality of life. Participants will undergo spinal manipulation therapy over a period of four weeks, with outcomes measured before and after treatment using objective and subjective assessments. The findings of this study could provide insights into the holistic benefits of spinal manipulation in addressing both musculoskeletal and psychosocial aspects of forward shoulder posture.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Presence of Neck Pain Both groups must report neck pain for at least 3 months chronic with a pain intensity of greater than 3 by 10 on the Visual Analog Scale Neck Pain with Forward Shoulder Posture Diagnosed with Forward Shoulder Posture using photogrammetry or clinical methods eg shoulder angle greater than 25° deviation from the vertical axis Activity Level Sedentary to moderately active individuals to control for activity level as a confounding factor General Health Participants must be otherwise healthy with no systemic diseases affecting musculoskeletal or nervous systems BMI Range: Normal or overweight individuals BMI between 18 & 5 and 30 kg by m² to minimize variability due to extreme body compositions Consent Willingness to participate and provide informed consent after understanding the studys procedures.

排除标准

  • History of Major Spinal Injury or Surgery Individuals with a history of spinal surgery significant spinal injury or severe musculoskeletal abnormalities are excluded to avoid confounding factors and ensure safety during spinal manipulation Pregnancy Pregnant individuals are excluded as pregnancy related changes in posture respiratory function and ANS balance may introduce variability in the results and could increase risks associated with spinal manipulation Chronic Pain Conditions or Severe Psychological Disorders Participants with chronic pain conditions eg fibromyalgia or severe mental health disorders are excluded as these conditions can affect psychosocial outcomes and pain perception making it difficult to isolate the effects of spinal manipulation on FSP Use of Medications Affecting the Autonomic Nervous System Participants currently taking medications that influence the ANS such as beta blockers are excluded to avoid pharmacological interference with the ANS measurements.
  • No Recent History of Spinal Manipulation or Postural Therapy Participants should not have undergone spinal manipulation physical therapy or other postural interventions in the last six months This criterion is to ensure baseline comparability and to eliminate the effects of previous interventions on the study outcomes Acute Neck Pain Participants with acute or recent neck pain smaller than 3 months.

结局指标

主要结局

Pain

时间窗: T1 before starting treatment | T2 after 4 weeks of starting treatment | T3 after 8 weeks of treatment

heart rate variabilty (ANS Function)

时间窗: T1 before starting treatment | T2 after 4 weeks of starting treatment | T3 after 8 weeks of treatment

Pulomoary function

时间窗: T1 before starting treatment | T2 after 4 weeks of starting treatment | T3 after 8 weeks of treatment

Posture

时间窗: T1 before starting treatment | T2 after 4 weeks of starting treatment | T3 after 8 weeks of treatment

次要结局

  • Quality of life(Stress)

研究者

发起方
AIIMS NEW DELHI
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

ASHISH TYAGI

AIIMS , NEW DELHI

研究点 (1)

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