NCT07132229

Brief Summary

Purposes of the study To investigate the effect of adding Cervical High-Intensity Resistive Exercises to conventional physical therapy in patients with Chronic Non-Specific Neck Pain

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

August 5, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

August 10, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

August 5, 2025

Last Update Submit

August 18, 2025

Conditions

Keywords

neck paincervical painHigh-Intensity Resistive Exercises

Outcome Measures

Primary Outcomes (4)

  • Disability

    Neck disability index (NDI)

    Change from Baseline Disability at 6 weeks

  • Diaphragm thickness

    Ultrasound

    Change from Baseline Diaphragm thickness at 6 weeks

  • Forced vital capacity (FVC)

    Spirometry

    Change from Baseline Forced vital capacity (FVC) at 6 weeks

  • maximum voluntary ventilation (MVV)

    Spirometry

    Change from maximum voluntary ventilation (MVV) at 6 weeks

Secondary Outcomes (2)

  • Neck pain

    Change from Baseline Neck pain at 6 weeks

  • Strength of neck flexors, extensors, and side bending

    Change from Baseline Strength of neck flexors, extensors, and side bending at 6 weeks

Study Arms (2)

Cervical High-Intensity Resistive Exercises + Conventional physical therapy

EXPERIMENTAL

Patients in this group will receive Cervical High-Intensity Resistive Exercises + Conventional physical therapy

Other: Cervical High-Intensity Resistive ExercisesOther: Conventional physical therapy

Conventional physical therapy

ACTIVE COMPARATOR

Patients in this group will receive Conventional physical therapy

Other: Conventional physical therapy

Interventions

The patient will wear a neck harness, and a weight equivalent to 90% of the patient's measured maximum voluntary isometric contraction (MVIC) will be attached to it.

Cervical High-Intensity Resistive Exercises + Conventional physical therapy

Conventional physical therapy consisting of TENS for pain control, soft tissue release for the cervical and associated muscles, activation and strengthening exercises for the deep neck flexors, extensors, and scapular muscles, as well as diaphragmatic breathing exercises.

Cervical High-Intensity Resistive Exercises + Conventional physical therapyConventional physical therapy

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Thirty-four patients diagnosed CNSNP.
  • Age of the patients between 20-40 years.
  • Non-specific neck pain started more than 3 months.
  • Reduce ventilatory function; FVC \>= 70% from predicted.
  • Waist to height ratio (WtHR)\> 60 %.
  • Positive craniocervical flexion test.
  • Positive neck flexor endurance test.
  • Pain at neck after prolonged static weight bearing positions.
  • Pain with palpation of the neck paraspinal or suboccipital or trapezius muscles.

You may not qualify if:

  • History of whiplash injury.
  • Clinical sign of cervical radiculopathy.
  • Clinical signs of cervical myelopathy.
  • Rheumatoid Arthritis or any other autoimmune diseases.
  • Any respiratory disorders.
  • Tumors.
  • vertebrobasilar insufficiency VBI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

outpatient clinic, Faculty of Physical Therapy, Cairo University

Giza, Egypt, 12613, Egypt

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
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate in Physical Therapy, Cairo University

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 20, 2025

Study Start

August 10, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

August 20, 2025

Record last verified: 2025-08

Locations