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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05220852
• Other study ID #: IRB-PGS-2021-03-209
• Status: Completed
• Phase: Phase 3
• Start date: February 6, 2022
• Est. completion date: August 9, 2022

Study information

• Verified date: October 2022
• Source: Imam Abdulrahman Bin Faisal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 9, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neck Pain

Intervention

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

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

Locations

Country	Name	City	State
Saudi Arabia	Imam Abdulrahman Bin Faisal University	Dammam	Eastern Province

Sponsors (1)

Lead Sponsor	Collaborator
Imam Abdulrahman Bin Faisal University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	"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)
Primary	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)
Primary	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)