AzTrials
AzTrials

Neck PainPhase 3NCT05220852

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

A Phase 3 study testing Dry needling with exercise and Exercise in people with Neck Pain, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Neck Pain
What is being tested?
Dry needling with exercise and Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteSaudi Arabia
Study dates
6 Feb 2022to 9 Aug 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • -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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

  • Imam Abdulrahman Bin Faisal University

    Dammam, Eastern Province, 718134714

Other trials in Saudi Arabia

About this study

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.

Read more

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.

Read the 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.

Conditions
Neck Pain
Being tested
Dry needling with exercise, Exercise
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dry needling with exerciseCombination product

    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

  • ExerciseOther

    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
Study groups in NCT05220852
Study groupRoleWhat they receive
Dry needling and exerciseExperimentalSubjects 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.
Receives: Combination Product: Dry needling with exercise
ExerciseActive comparatorsubjects in this group will have neck exercise only for 2 weeks minimum 3 times a week.
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)

  2. "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)

    Measured: 2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)

  3. 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

    Measured: 2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)

  4. 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)

    Measured: 2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2022
  2. Study start6 Feb 2022
  3. Primary completion15 Jun 2022
  4. Study completion9 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
RTC single-blind
Masking
Single blind
Who is masked
Participant
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05220852
Sponsor's protocol ID
IRB-PGS-2021-03-209
Status last verified
Oct 2022
First submitted
3 Dec 2021
Last updated
5 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dry needling with exercise and Exercise in people with Neck Pain, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric pain rating scale (time frame: 2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05220852, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.

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