NCT05712239

Brief Summary

Chronic non-specific neck pain patients will be enrolled in 3 groups in this study including passive, active control and experimental groups to determine the effect of adding lumbar core stability exercises to patient's advices and cervical and scapular stabilization exercises. For the last two groups, the sessions will be applied 3 times per week for 4 weeks. All the outcomes will be measured after patient's enrollment and at the end of 4 weeks to determine the difference between groups.

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
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

January 26, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

February 5, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

12 months

First QC Date

January 26, 2023

Last Update Submit

August 30, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • change in pain intensity

    Pain intensity will be assessed by using Visual analogue scale (VAS). It is horizontal line with 10 cm length, with Zero marked at one end representing no pain and 10 marked at the other end representing worst imaginable pain.

    This outcome will be assessed at the first day and after 4 weeks following end of treatment

  • change in functional disability

    Functional disability will be assessed using Arabic version of neck disability index. The patients will be asked to make a mark in each section which most closely described their problem. Each section consists of six potential responses for each item ranging from no disability (0) to total disability (5). Thus, The NDI score ranges between 0-100, with higher scores indicating greater perceived disability. The score of less than 4 indicates no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, and scores greater than 35 complete disabilities.

    This outcome will be assessed at the first day and after 4 weeks following end of treatment

Secondary Outcomes (6)

  • change in Craniovertebral angle degree (CVA)

    This outcome will be assessed at the first day and after 4 weeks following end of treatment

  • change of of deep neck flexor muscles (DNF) activation

    This outcome will be assessed at the first day and after 4 weeks following end of treatment

  • change of deep neck flexor (DNF) endurance

    This outcome will be assessed at the first day and after 4 weeks following end of treatment

  • change of trunk flexor muscle endurance

    This outcome will be assessed at the first day and after 4 weeks following end of treatment

  • change of trunk extensor muscle endurance

    This outcome will be assessed at the first day and after 4 weeks following end of treatment

  • +1 more secondary outcomes

Study Arms (3)

Advices Group

OTHER

Patients in this group will take only advices about their postures and activities of daily living

Other: Advices

Cervical and scapular stabilization Group

ACTIVE COMPARATOR

Patients in this group will take advices and stability exercises for neck and scapula

Other: AdvicesOther: Cervical and Scapular Stabilization Exercises

Neck, scapular and lumber stabilization Group

EXPERIMENTAL

Patients in this group will take advices, and stability exercises for neck, scapula and lumber spine

Other: AdvicesOther: Cervical and Scapular Stabilization ExercisesOther: Lumber Core Stability Program

Interventions

AdvicesOTHER

The advices will include patient's reassurance and description of possible causes of neck pain such as poor working ergonomics, common bad postures especially while using electronic devices for long periods and not adjustable sleeping pillows. Also, patient will be educated how to modify these different causes and asked to apply gentle neck range of motion exercises

Advices GroupCervical and scapular stabilization GroupNeck, scapular and lumber stabilization Group

Deep neck flexor training will be performed in neurodevelopment stages (supine at first week using pressure biofeedback unit , prone at second week, quadrupedal at third week, bipedal at fourth week). Scapular stabilization exercises will include modified prone cobra, trapezius muscle exercise progression (3 stages), wall press and extension of the thoracic spine using foam roller. The modified prone cobra and the first stage of trapezius muscle exercise progression will be applied during the first two weeks. The second and third stages of trapezius muscle exercise will be applied during the last two weeks of our rehabilitation program. All exercises will be applied for 10 repetitions with 6-10 sec hold for 3 sets with 20 sec rest between each set. While wall press and thoracic extension exercises will be applied throughout the 4 weeks for 3 sets of 10 repetitions with 20 sec rest between each set.

Cervical and scapular stabilization GroupNeck, scapular and lumber stabilization Group

The program will be performed in three stages: activation, dynamic stabilization, and advanced core strengthening stages. Each stage will be applied for 4 sessions. The activation stage will be based on the learning to activate transversus abdominis muscle from crock lying position using pressure biofeedback unit. In the dynamic stabilization stage, the patient will be instructed to slowly raise both arms in the scapular plan then return to the sides while maintaining the transversus abdominis muscle activation. Also, the patient will apply bridging exercise in this stage. The advanced core strengthening stage will include prone plank and side plank (right and left sides). All the exercises will be applied for 10 repetitions with 6-10 sec hold for 3 sets. The rest of 20 sec will be taken between each set.

Neck, scapular and lumber stabilization Group

Eligibility Criteria

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

You may qualify if:

  • Patients with persistent cervical pain for more than 12 weeks without specific diagnosis (chronic non-specific neck pain).
  • BMI less than 30 kg/m2.
  • Pain intensity on VAS should be more than 3.
  • Patient will be able and motivated in completing the study.
  • Psychologically \& mentally stable.

You may not qualify if:

  • Red Flag's symptoms including a history of major trauma, persistent night pain, bladder or bowel dysfunction, and/or lower or upper extremity neurological deficit.
  • Pregnant women.
  • Recent or old fractures at spine or upper limbs.
  • Congenital, or acquired postural deformity.
  • No previous neck or spinal or shoulder surgery.
  • No current pathologies (e.g. Disc lesion, nerve root compression, canal stenosis, spinal tumor, spinal infection, systemic inflammatory diseases, …).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Neck Pain

Interventions

Counseling

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Hend W Mostafa, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
To confirm blindness, all patients will be unaware of the group allocation and the exercises performed by the other group. Also, the pictures of craniovertebral angle will be coded before being measured
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 3, 2023

Study Start

February 5, 2023

Primary Completion

February 1, 2024

Study Completion

April 1, 2024

Last Updated

September 5, 2023

Record last verified: 2023-08

Locations