Effects of Dry Needling and Dry Needling Combined with Electrical Stimulation on Pain and Function in Patients with Subacute Musculoskeletal Neck Pain following Myofascial Trigger Points
The main object of this research is study comparing effects of dry needling combined with electrical stimulation versus dry needling alone on pain and function in patients with subacute neck pain following myofascial trigger points in upper quadrant muscles
Design
It will be a Double Blinded RCT. A total of 30 participants will be randomly divided into 2 groups i-e. treatment and control group. The total number of sessions will be 6 for 3 weeks with pre and post-treatment assessment.
Settings and conduct
Data will be collected from the Department of Rehabilitation Imam Hasan Hospital, Karbala, Iraq.
The principal investigator will assign two therapists for this double-blinded RCT. After the screening and randomization, therapist number 1 will perform the pre-treatment assessment, the Therapist number 2 will treat the patients as per their group. After 6 sessions, therapist number 1 will again perform the post-treatment assessment. Therapist number 1 will be blinded to the treatment groups, while therapist number 2 will be blinded to the research hypothesis and objectives.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Both genders. Patients having subacute neck pain. Ages between 25-45 years. Neck pain between 30-70 on the visual analog scale score during activity and rest. Unilateral sub-acute trigger point from the past 22-84 days
Exclusion Criteria:
Patients having systemic disorders or migraine. Patients taking medication for pain in the previous 3 weeks prior to the study. The pregnant women. The patient having trauma in the neck during the past 6 months. The patients with skin inflammation and open wounds. Refuse to take part
Intervention groups
Group 1: Dry needling with a hot pack
Group 2: Electrical Dry needling with a hot pack
Main outcome variables
Visual Analog Scale
Range of Motion of Cervical Spine
Functional Capacity Evaluation
Neck Disability Index
General information
Reason for update
Acronym
MPS (Myofascial Pain Syndrome)
IRCT registration information
IRCT registration number:IRCT20230604058379N1
Registration date:2023-07-05, 1402/04/14
Registration timing:registered_while_recruiting
Last update:2023-07-05, 1402/04/14
Update count:0
Registration date
2023-07-05, 1402/04/14
Registrant information
Name
ali Al Chlaihawi
Name of organization / entity
Country
Iraq
Phone
+964 781 530 7009
Email address
nangy489@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-01, 1402/04/10
Expected recruitment end date
2023-08-10, 1402/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Dry Needling and Dry Needling Combined with Electrical Stimulation on Pain and Function in Patients with Subacute Musculoskeletal Neck Pain following Myofascial Trigger Points
Public title
Effects of Dry Needling with Electrical Stimulation in The Treatment Subacute Neck Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both genders.
The patients must have sub acute neck pain.
The patients must have unilateral neck pain following the myofascial trigger point in the upper quadrant muscles.
Age between 25-45 years.
The patients must present unilateral sub-acute trigger point signs and symptoms from past 22 -84 days.
The number of identified trigger points at the area must be between 5 – 10 and can be specified for all upper quadrant muscles.
Exclusion criteria:
The patients who had a systemic disorder or migraine
The patients were on medication for trigger points or physiotherapy treatment in previous 3 weeks prior to the study
The pregnant women.
The patient had trauma in the neck area during the past 6 months
The patients with skin inflammation
The patients with the pen wounds
The patients who refused to continue the study for any reason
The patients who had needle phobia
The patients who had a bleeding disorder
The patients who had a cognitive disorder
The patients who had tumors or a background of malignancy disorders
Age
From 25 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
We will use a simple lottery method for the random allocation of patients into the treatment and control groups. Equal size allocation will be done in this study. All the patients will be given a unique number after screening and then the numbers will be written on small papers of equal size. After that, all the papers will be put in a box and shuffled. For the treatment group, one slip will be taken out by the patient and handed over to the therapist. The same procedure will be used for control group allocation. This sequence will be repeated till all the patients will be allocated into groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this open-label study, the physiotherapist was not blind to the groups. However, both the participants and the assessor would be blinded to the treatment protocols. The participants will also get verbal explanations of the study's purpose and the procedures that would be applied before any intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the Faculty of Nursing and Midwifery and the Faculty of Rehabilitation - Tehran
Street address
School of Rehabilitation of Tehran University of MedicalSciences, Piche Shemiran, Enghelab Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2023-05-13, 1402/02/23
Ethics committee reference number
IR.TUMS.FNM.REC.1402.025
Health conditions studied
1
Description of health condition studied
Subacute Neck Pain for more than 3 weeks
ICD-10 code
M54.2
ICD-10 code description
Cervicalgia
Primary outcomes
1
Description
Visual Analog Scale for Pain
Timepoint
Before intervention and after 3 weeks.
Method of measurement
The therapist will ask the patient to report their pain using Visual Analog Scale.
2
Description
Range of Motion of Cervical Spine
Timepoint
Before intervention and after 3 weeks.
Method of measurement
The therapist will use Bubble Inclinometer to measure the range of motion of the cervical spine.
3
Description
Functional Capacity Evaluation
Timepoint
Before intervention and after 3 weeks.
Method of measurement
The therapist will measure the score of functional capacity evaluation.
4
Description
Neck Disability Index
Timepoint
Before intervention and after 3 weeks.
Method of measurement
The therapist will measure the score of the Neck Disability Index.
Secondary outcomes
1
Description
Disability
Timepoint
Before treatment and after 3 weeks
Method of measurement
Neck Disability Index (NDI)
Intervention groups
1
Description
Intervention group: The participants will be randomly allocated into two groups:Group-1 The patients will be under the application of [Dry needling with hot pack] Group -2 The patients will be under the application of [Electrical Dry needling with hot pack [ All participants were lying in prone position and did receive standard medical care including 7 minutes of superficial heat (hot pack) before and after applying Dry needling. The period between hot pack and dry needling was about 3 min. Each protocol of intervention consists of 6 sessions for 3 weeks (2 sessions per week). The participants should not take any other treatment during research time. They must also follow the routine life without any extra activities such as sewing, typing, etc.