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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05712239
Other study ID # P.T.REC/012/003950
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 5, 2023
Est. completion date April 1, 2024

Study information

Verified date August 2023
Source Cairo University
Contact Hend W Mostafa, MSc
Phone 00201004225661
Email hendwageh.95@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date April 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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, …).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Advices
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
Cervical and Scapular Stabilization Exercises
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.
Lumber Core Stability Program
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.

Locations

Country Name City State
Egypt Faculty of Physical Therapy, Cairo University Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 change in Craniovertebral angle degree (CVA) To measure CVA, the patient will be captured from the left side after putting landmarks on seventh cervical vertebra (c7) and tragus of the ear. The photograph will be taken and analyzed with kinovea software by drawing a horizontal line passing through C7 and line connecting between the tragus of the ear and C7 and measuring the angle between these lines. As the value of CVA decreases, the degree of FHP increases This outcome will be assessed at the first day and after 4 weeks following end of treatment
Secondary change of of deep neck flexor muscles (DNF) activation DNF activation will be assessed by Craniocervical flexion test using Pressure biofeedback unit This outcome will be assessed at the first day and after 4 weeks following end of treatment
Secondary change of deep neck flexor (DNF) endurance DNF endurance will be assessed by Neck flexor endurance test This outcome will be assessed at the first day and after 4 weeks following end of treatment
Secondary change of trunk flexor muscle endurance Trunk flexor muscle endurance will be assessed by Trunk flexion test (McGill's test) This outcome will be assessed at the first day and after 4 weeks following end of treatment
Secondary change of trunk extensor muscle endurance Trunk extensor muscle endurance will be assessed by Trunk extension test (Sorenson Test) This outcome will be assessed at the first day and after 4 weeks following end of treatment
Secondary change of lateral trunk muscle endurance Lateral trunk muscle endurance will be assessed Side plank test for left and right sides This outcome will be assessed at the first day and after 4 weeks following end of treatment
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