Effects of Dry Needling With a Standard Exercise Programme on Pain and Quality of Life in Patients With Chronic Mechanical Neck Pain

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Combination product: Dry needling with exercise; Other: Exercise

Detailed Description

Procedure

The lead investigator screened the participants to ensure that they met the requirements for participation in the study.

The participants were randomly divided into the "control group" and the "experimental group."

Intervention

Needling dry

The experimental group will receive dry needling in addition to the exercise routine, while the control group will just receive the exercise protocol.

The trigger point (TrP) DN will be used, and a TrP location will be palpated and designated for needle insertion in the upper trapezius muscle. Stainless-steel disposable needles 0.3 30 mm; Novasan, S.A.

The needle will be placed into the skin for up to 10 to 15 mm, until a local twitch reaction is felt, and the person will be monitored for two weeks after that. For two weeks, the participant will begin the workouts once daily.

Protocol for neck exercise:

Both the experimental and control groups will get a standardized workout regimen that included neck and upper back muscular stretching and strengthening.

Confidentiality:

Data will be collected collectively and maintained confidentially in a computer protected by a password; no individual's name will be revealed.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 3

Contacts and Locations

Study Locations

• Saudi Arabia
  • Eastern Province
    • Dammam, Eastern Province, Saudi Arabia, 718134714
      • Imam Abdulrahman Bin Faisal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-Participants who have been given a primary care doctor's or an orthopaedic consultant's medical diagnosis of chronic mechanical neck discomfort will be screened by the lead investigator.

2- Participants who were diagnosed with chronic neck discomfort that was brought on by neck movements, postures, and cervical palpation 3. Neck ache that has persisted for longer than a month. 4- Participants must not be receiving any treatment for their persistent neck discomfort at the time they are recruited for the study.

Exclusion Criteria:

- Neurologic impairments are symptoms of radiculopathy, according to participants.

• Medical diagnosis of cervical myelopathy or radiculopathy

  . Aversion to needles

• A history of shoulder, whiplash, or cervical spine injuries that was reported. Any "red flags" (malignancy, inflammatory arthritis, fracture, osteoporosis, and others).

patient with a congenital condition

- Any treatment that research participants may have been receiving at the time of recruitment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry needling and exercise; 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.	Combination product: Dry needling with exercise; 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.; Cranio-cervical spine flexion is the exercise.; Extension of the cranio-cervical spine Exercice 3 Shoulder Elevation 4-Retraining of the scapular muscles Every exercise should be done for 30 se
Active Comparator: Exercise; subjects in this group will have neck exercise only for 2 weeks minimum 3 times a week.	Other: Exercise; patients in this group are going to have onley neck exercise for 2 weeks minimum 3 times a week.; Cranio-cervical spine flexion is the exercise.; Extension of the cranio-cervical spine Exercice 3 Shoulder Elevation 4-Retraining of the scapular muscles Every exercise should be done for 30 se

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Imam Abdulrahman Bin Faisal University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2022
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): August 9, 2022

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: IRB-PGS-2021-03-209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No