NCT07102199

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 3, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

July 21, 2025

Last Update Submit

July 28, 2025

Conditions

Keywords

attentional focusmechanical neck paincraniovertebral angle

Outcome Measures

Primary Outcomes (1)

  • Neck Disability Index (NDI)

    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).

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

Secondary Outcomes (7)

  • 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.

  • 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.

  • Pressure Pain Threshold Measurement (PPT)

    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.

  • +2 more secondary outcomes

Study Arms (3)

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.

Other: Internal focus of attention instructions- FirstOther: Home exercises

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.

Other: External focus of attention instructions- FirstOther: Home exercises

CG

ACTIVE COMPARATOR

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

Other: Home exercises

Interventions

Participants first received internal focus instructions, directing their attention to their own body, followed by external focus instructions.

IFO-First

Participants first received internal focus instructions, directing their attention to their own body, followed by external focus instructions.

EFA-Firts

Participants' home exercise program includes cervical and scapulothoracic stabilization exercises and self-mobilization exercises with the self-sustained natural apophyseal glide (SNAG) method.

CGEFA-FirtsIFO-First

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Nişantaşı University

Istanbul, Sarıyer, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study has a randomized, controlled, single-blind, prospective study design.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physiotherapist, Research Assistant

Study Record Dates

First Submitted

July 21, 2025

First Posted

August 3, 2025

Study Start

May 1, 2025

Primary Completion

November 30, 2025

Study Completion

December 31, 2025

Last Updated

August 3, 2025

Record last verified: 2025-07

Locations