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

Primary Purpose

Neck Pain

Status
Completed
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Dry needling with exercise
Exercise
Sponsored by
Imam Abdulrahman Bin Faisal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Imam Abdulrahman Bin Faisal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry needling and exercise

Exercise

Arm Description

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.

subjects in this group will have neck exercise only for 2 weeks minimum 3 times a week.

Outcomes

Primary Outcome Measures

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).
"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)
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
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)

Secondary Outcome Measures

Full Information

First Posted
December 3, 2021
Last Updated
October 3, 2022
Sponsor
Imam Abdulrahman Bin Faisal University
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1. Study Identification

Unique Protocol Identification Number
NCT05220852
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 6, 2022 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
August 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imam Abdulrahman Bin Faisal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
RTC single-blind
Masking
Participant
Masking Description
all the research subjects were masked and enrolled by picking up one of two sealed envelope to take place in one of the groups
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry needling and exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
subjects in this group will have neck exercise only for 2 weeks minimum 3 times a week.
Intervention Type
Combination Product
Intervention Name(s)
Dry needling with exercise
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Numeric pain rating scale
Description
used to assess the intensity of the pain , the NPS ranges between 0 and 10 (0: minimum pain, 10: maximum pain).
Time Frame
2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)
Title
"Short Form-36 Quality of Life Scale (SF-36 QOLS)
Description
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)
Time Frame
2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)
Title
Beck Depression Inventory (BDI)
Description
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
Time Frame
2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)
Title
The functional disability, Neck Disability Index (NDI)
Description
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)
Time Frame
2 times From admission to discharge, up to 2 week (pre first intervention and post last intervention)

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
18-60
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Imam Abdulrahman Bin Faisal University
City
Dammam
State/Province
Eastern Province
ZIP/Postal Code
718134714
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
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.
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Effects of Dry Needling With a Standard Exercise Programme on Pain and Quality of Life in Patients With Chronic Mechanical Neck Pain

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