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

Phase 3

Completed

• Conditions: Neck Pain
• Interventions: Other: Exercise; Combination Product: Dry needling with exercise

• Registration Number: NCT05220852
• Lead Sponsor: Imam Abdulrahman Bin Faisal University

Brief 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.

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 Timeline

• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2022-01-21
• Study First Posted: 2022-02-02
• Study Start: 2022-02-06
• Primary Completion: 2022-06-15
• Study Completion: 2022-08-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-03
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	subjects in this group will have neck exercise only for 2 weeks minimum 3 times a week.
Dry needling and exercise	Dry needling with 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.

Primary Outcome Measures

Name	Time	Method
"Short Form-36 Quality of Life Scale (SF-36 QOLS)	2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)	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)
Beck Depression Inventory (BDI)	2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)	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
The functional disability, Neck Disability Index (NDI)	2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)	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)
Numeric pain rating scale	2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)	used to assess the intensity of the pain , the NPS ranges between 0 and 10 (0: minimum pain, 10: maximum pain).

Trial Locations

Locations (1)

Imam Abdulrahman Bin Faisal University; 🇸🇦 Dammam, Eastern Province, Saudi Arabia