跳至主要内容
临床试验/NCT07102199
NCT07102199进行中(未招募)不适用

Effectiveness of Differently Sequenced Attentional Focus Instructions in a Home Exercise Program for Non-Specific Neck Pain: A Randomized Controlled Single-Blind Trial

Büşra Tamgüç1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
39
试验地点
1
主要终点
Neck Disability Index (NDI)

研究概览

简要总结

According to the International Association for the Study of Pain's 2017 terminology, neck pain is described as an unpleasant sensory and emotional experience originating in the cervical region and potentially radiating toward the scapular area, typically linked to actual or potential tissue injury. Although research on how attentional focus instructions influence postural control remains limited, existing findings suggest that the sequence in which these instructions are delivered can impact sensory processing during postural control assessments. These observations raise compelling questions about the potential benefits of using attentional focus strategies in a structured, sequential manner during neck pain treatment. To date, however, no study has investigated how varying the order of attentional focus cues within a home exercise program affects individuals with non-specific neck pain. This study aimed to fill that gap by evaluating the clinical effectiveness of a home-based exercise protocol utilizing attentional focus instructions in different sequences. The primary outcome was disability level, measured by the Neck Disability Index (NDI). Secondary outcomes included pain intensity assessed via the Visual Analog Scale (VAS), craniovertebral angle (CVA) via photogrammetry, pressure pain threshold (PPT), cervical joint range of motion, dizziness-related disability (Dizziness Handicap Inventory), and the endurance of neck flexor and extensor muscles.

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)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged between 18 and 40 years
  • •A craniovertebral angle of 53 degrees or less
  • •A Visual Analog Scale score greater than 3 for pain in the neck and shoulder areas
  • •Experiencing head and neck pain for a duration exceeding three months
  • •A Neck Disability Index score ranging from 5 to 24
  • •A positive result on the cervical flexion-rotation test
  • •A body mass index within the range of 18.5 to 25 kg/m²
  • •No history of injury to the neck, trunk, or upper and lower extremities in the past six months

排除标准

  • •A positive result on the Spurling test
  • •Reduced or absent reflex responses in the upper extremities,
  • •Referred pain scoring greater than 7 on the Visual Analog Scale in the affected dermatome
  • •Diagnosis of cervical spinal stenosis
  • •Diagnosis of an autoimmune disorder
  • •Previous surgical intervention in the cervical or shoulder region
  • •A positive result on the Vertebrobasilar insufficiency test
  • •Presence of any musculoskeletal deformity or abnormality
  • •Inability to carry out functional activities due to visual, auditory, vestibular, or neurological impairments
  • •Neck pain associated with malignancy or structural abnormalities
  • •Clinical presentation consistent with a capsular pattern suggestive of arthritis, or the presence of a severe psychological disorder
  • •Current pregnancy
  • •Participation in any form of exercise-based treatment or physiotherapy within the last three months

研究组 & 干预措施

IFO-First

Experimental

Participants included in the study will follow a home exercise program for 3 days a week for 4 weeks, in accordance with the instructions given to their groups. The IFO-First group will first receive internal attention focus instructions, then external attention focus.

干预措施: Internal focus of attention instructions- First (Other)

EFA-Firts

Experimental

Participants included in the study will follow a home exercise program for 3 days a week for 4 weeks, in accordance with the instructions given to their groups. The EFO-First group will first receive external focus instructions, then internal focus of attention instructions.

干预措施: Home exercises (Other)

IFO-First

Experimental

Participants included in the study will follow a home exercise program for 3 days a week for 4 weeks, in accordance with the instructions given to their groups. The IFO-First group will first receive internal attention focus instructions, then external attention focus.

干预措施: Home exercises (Other)

EFA-Firts

Experimental

Participants included in the study will follow a home exercise program for 3 days a week for 4 weeks, in accordance with the instructions given to their groups. The EFO-First group will first receive external focus instructions, then internal focus of attention instructions.

干预措施: External focus of attention instructions- First (Other)

CG

Active Comparator

Participants included in the study will follow a home exercise program without any instructions, 3 days a week for 4 weeks.

干预措施: Home exercises (Other)

结局指标

主要结局

Neck Disability Index (NDI)

时间窗: The assessment will be performed at two time points: baseline and 4 weeks after the intervention.

The Neck Disability Index (NDI) was used to assess disability resulting from neck pain. The NDI consists of 10 items: four addressing subjective symptoms (pain intensity, headache, concentration, and sleeping), and six assessing activities of daily living (personal care, lifting, reading, work activities, driving, and recreation). Each item is scored on a scale from 0 to 5, with total scores ranging from 0 (no disability) to 50 (maximum disability); lower scores indicate less disability. According to the literature, the minimal clinically important difference (MCID) for the NDI has been reported to be 7 points (Abbott, 2014).

次要结局

  • Pain Intensity Based on Visual Analog Pain Scale (VAS)(The assessment will be performed at two time points: baseline and 4 weeks after the intervention.)
  • Cervical Joint Range of Motion Measurement(The assessment will be performed at two time points: baseline and 4 weeks after the intervention.)
  • Dizzines Handicap Inventory(The assessment will be performed at two time points: baseline and 4 weeks after the intervention.)
  • Craniovertebral angle measurement(The assessment will be performed at two time points: baseline and 4 weeks after the intervention.)
  • Endurance Test for Neck Extensors(The assessment will be performed at two time points: baseline and 4 weeks after the intervention.)
  • Pressure Pain Threshold Measurement (PPT)(The assessment will be performed at two time points: baseline and 4 weeks after the intervention.)
  • Endurance Test for Neck Flexors(The assessment will be performed at two time points: baseline and 4 weeks after the intervention.)

研究者

发起方
Büşra Tamgüç
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Büşra Tamgüç

Physiotherapist, Research Assistant

Bahçeşehir University

研究点 (1)

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