NCT05220852|CompletedPhase 3DMC
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Sponsor study identifier
interventional
31
1 country
1
Study Start
February 6, 2022
Actual (reported)Primary Completion
June 15, 2022
Actual (reported)Study Completion
August 9, 2022
Actual (reported)Abstract\\sBackground Physical therapists frequently utilize dry needling (DN), which focuses on trigger points and non-trigger point structures, to treat mechanical neck pain (MNP). It is an invasive procedure that involves inserting solid fiber needles into myofascial trigger points or hyperirritable nodules that are painful to the touch. This procedure can affect the motor and autonomic neurons and relieve pain. Objectives examining the short-term effects of dry needling in combination with a standardized exercise program on pain and quality of life in chronic mechanical neck pain Methods The allocation of 18 participants to the DN or Exercise intervention groups will be done at random. Before the exam, the Beck Depression Inventory (BDI), Neck Disability Index (NDI), Short Form-36 Quality of Life Scale, and Numerical Rating Scale (NPS-11) will be evaluated. Analytical Statistics For the statistical analysis of the data, SPSS 23.0 will be employed. The "Kolmogorov-Smirnov test" will be used to determine whether the data are distributed normally. The effectiveness of each intervention will be determined using a paired t test, and between-group comparisons will be made using an independent t test. The distribution of categorical variables will be compared using a chi-square test. A 95% confidence interval and p0.05 will be used to determine significance. Key words: mechanical neck pain, dry needling, neck exercises, and quality of life.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 9, 2022
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 3, 2021
Actual (reported)February 2, 2022
Actual (reported)February 6, 2022
Actual (reported)June 15, 2022
Actual (reported)August 9, 2022
Actual (reported)Numeric pain rating scale
used to assess the intensity of the pain , the NPS ranges between 0 and 10 (0: minimum pain, 10: maximum pain).
2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)
"Short Form-36 Quality of Life Scale (SF-36 QOLS)
for assessing the physical functions of the body through analysis of body pain, physical role difficulties (PRD), vitality/energy, the general perception of health, social functions and mental health. The sub-scores will be calculated separately between 0 and 100 (0: the worst, 100: the best health status)
2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)
Beck Depression Inventory (BDI)
To assess patient depression,The total score of BDI were evaluated between 0 and 63. BDI scores near to high range or above than that indicate more severe forms of depression
2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)
The functional disability, Neck Disability Index (NDI)
has been designed to assess the pain intensity of the neck and how it affects the quality of life by affecting daily activities. The total NDI score is 0 and 54 and consists of 10 questions.(less score less disability)
2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)
Subjects in this group will undergo one session of dry needling in their upper trapezius muscles to address any overactive trigger points, and they will subsequently continue with neck exercises for a minimum of two weeks, three times per week.
subjects in this group will have neck exercise only for 2 weeks minimum 3 times a week.
At the initial session, dry needling will be given to their upper trapezius muscles' hyperactive trigger sites, and EX will continue for a minimum of three times per week. 1. Cranio-cervical spine flexion is the exercise. 2. Extension of the cranio-cervical spine Exercice 3 Shoulder Elevation 4-Retraining of the scapular muscles Every exercise should be done for 30 se
patients in this group are going to have onley neck exercise for 2 weeks minimum 3 times a week. 1. Cranio-cervical spine flexion is the exercise. 2. Extension of the cranio-cervical spine Exercice 3 Shoulder Elevation 4-Retraining of the scapular muscles Every exercise should be done for 30 se
Imam Abdulrahman Bin Faisal University
Dammam, Eastern Province, 718134714, Saudi Arabia
Abbaszadeh-Amirdehi, M. et al. (2017) 'Therapeutic Effects of Dry Needling in Patients with Upper Trapezius Myofascial Trigger Points', Acupuncture in Medicine, 35(2), pp. 85-92. doi: 10.1136/acupmed-2016-011082. 2. Alghadir, A. H., Anwer, S. and Iqbal, Z. A. (2016) 'The psychometric properties of an Arabic numeric pain rating scale for measuring osteoarthritis knee pain', Disability and Rehabilitation, 38(24), pp. 2392-2397. doi: 10.3109/09638288.2015.1129441. 3. Andersen, L. L. et al. (2011) 'Prevalence and anatomical location of muscle tenderness in adults with nonspecific neck/shoulder pain', BMC Musculoskeletal Disorders, 12(1), p. 169. doi: 10.1186/1471-2474-12-169. 4. 'ASAP_Guidelines_2013.pdf' (no date). Available at: https://www.dryneedling.com.au/wp-content/uploads/2016/01/ASAP_Guidelines_2013.pdf (Accessed: 28 March 2020). 5. Beck, A. T. et al. (1961) 'An inventory for measuring depression', Archives of General Psychiatry, 4, pp. 561-571. doi: 10.1001/archpsyc.1961.01710120031004. 6. Borg-Stein, J. (2004) 'Musculoskeletal head and neck pain', Seminars in Pain Medicine, 2(2), pp. 85-92. doi: 10.1016/j.spmd.2004.04.004. 7. Brady, S. et al. (2014) 'Adverse events following trigger point dry needling: a prospective survey of chartered physiotherapists', Journal of Manual & Manipulative Therapy, 22(3), pp. 134-140. doi: 10.1179/2042618613Y.0000000044. 8. Cerezo-Téllez, E. et al. (2016) 'Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial', PAIN, 157(9), pp. 1905-1917. doi: 10.1097/j.pain.0000000000000591. 9. Cross, K. M. et al. (2011) 'Thoracic Spine Thrust Manipulation Improves Pain, Range of Motion, and Self-Reported Function in Patients With Mechanical Neck Pain: A Systematic Review', Journal of Orthopaedic & Sports Physical Therapy, 41(9), pp. 633-642. doi: 10.2519/jospt.2011.3670. 10. Fawzi, M. H., Fawzi, M. M. and Abu-Hindi, W. (2012) 'Arabic version of the Major Depression Inventory as a diagnostic tool: reliability and concurrent and discriminant validity.', Eastern Mediterranean health journal = La revue de sante de la Mediterranee orientale = al-Majallah al-sihhiyah li-sharq al-mutawassit. doi: 10.26719/2012.18.4.304. 11. Geneen, L. J. et al. (2017) 'Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews', The Cochrane Database of Systematic Reviews, 2017(4). doi: 10.1002/14651858.CD011279.pub3. 12. Gerber, L. H. et al. (2015) 'Dry Needling Alters Trigger Points in the Upper Trapezius Muscle and Reduces Pain in Subjects with Chronic Myofascial Pain', PM & R : the journal of injury, function, and rehabilitation, 7(7), pp. 711-718. doi: 10.1016/j.pmrj.2015.01.020. 13. Graham, N. et al. (2008) 'Mechanical traction for neck pain with or without radiculopathy', Cochrane Database of Systematic Reviews, (3). doi: 10.1002/14651858.CD006408.pub2. 14. Gross, A. et al. (2010) 'Manipulation or mobilisation for neck pain: A Cochrane Review', Manual Therapy, 15(4), pp. 315-333. doi: 10.1016/j.math.2010.04.002. 15. Gross, A. et al. (2015) 'Exercises for mechanical neck disorders', The Cochrane database of systematic reviews, 1, p. CD004250.
31 participants (actual enrollment reported by the registry).
First Submitted
December 3, 2021
First Posted
February 2, 2022
Study Start
Effectiveness of Physical Exercise on Chronic Non-Specific Neck Pain
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
February 6, 2022
Primary Completion
June 15, 2022
Actual (reported)Study Completion
August 9, 2022
Actual (reported)Last Updated
October 5, 2022
Record last verified: 2022-10
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