Clinical trial NCT05220852: Effects of Dry Needling With a Standard Exercise Programme on Pain and Quality of Life in Patients With Chronic Mechanical Neck Pain
Official title: Effects of Dry Needling With a Standard Exercise Programme on Pain and Quality of Life in Patients With Chronic Mechanical Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neck Pain
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RTC single-blind
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numeric pain rating scale
timeFrame: 2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)
measure: "Short Form-36 Quality of Life Scale (SF-36 QOLS)
timeFrame: 2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)
measure: Beck Depression Inventory (BDI)
timeFrame: 2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)
measure: The functional disability, Neck Disability Index (NDI)
timeFrame: 2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Imam Abdulrahman Bin Faisal University
state: Eastern Province
Study officials:
References:
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