Effect of Levator Scapulae Muscle Dry needling on Clinical Symptom in Patients with Cervical Radiculopathy
Design
A Single Blind Randomized Controlled Trial
Settings and conduct
Participants in the control group will receive routine physiotherapy interventions for cervical radiculopathy. Those in the intervention group will receive dry needling therapy for the levator scapulae muscle, in addition to routine treatments. Outcome measures will be evaluated in both groups. Finally, all data will be statistically compared and analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Individuals medically diagnosed with radiculopathy and experiencing neck pain radiating to one of the upper limbs.
Age range between 18 and 55 years.
Neck and upper limb pain intensity between 3 and 8 based on the NRS (Numerical Rating Scale).
At least one month has passed since symptom onset.
Presence of an active trigger point in the affected levator scapula muscle, diagnosed by a physiotherapist.
Exclusion criteria:
History of previous neck surgery.
History of malignancy in the cervical or thoracic region.
Skin disorders in the neck and shoulder area.
Fear of needles.
Lack of cooperation during treatment.
Presence of cognitive impairment.
Previous neurological injuries in the upper limb.
Hyperreflexia.
Diagnosis of myelopathy.
History of trauma to the neck, thoracic, or shoulder area.
Intervention groups
Participants in this study will be randomly assigned to either the intervention or control group. Individuals in the control group will receive routine physiotherapy interventions for cervical radiculopathy. Participants in the intervention group will receive the same routine physiotherapy treatments, but in addition, they will undergo dry needling therapy for the levator scapulae muscle during the third, sixth, and ninth sessions.
Main outcome variables
Pain Intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200215046499N5
Registration date:2025-05-29, 1404/03/08
Registration timing:prospective
Last update:2025-05-29, 1404/03/08
Update count:0
Registration date
2025-05-29, 1404/03/08
Registrant information
Name
Hakimeh Adigozali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 5359
Email address
adigozalih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-05, 1404/04/14
Expected recruitment end date
2026-05-04, 1405/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Levator Scapulae Muscle Dry needling on Clinical Symptom in Patients with Cervical Radiculopathy: A Single Blind Randomized Controlled Trial
Public title
Effect of Levator Scapulae Muscle Dry needling
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals medically diagnosed with radiculopathy and experiencing neck pain radiating to one of the upper limbs.
Neck and upper limb pain intensity between 3 and 8 based on the Numerical Rating Scale (NRS).
At least one month has passed since symptom onset.
Presence of an active trigger point in the affected levator scapula muscle (diagnosed by a physiotherapist based on Travell & Simons criteria: (1) palpation of a taut band in the target muscle, (2) identification of a tender spot within the taut band, (3) reproduction of pain similar to the patient's complaint, and (4) painful limitation of the muscle's range of motion. Individuals with at least three of these criteria are considered to have an active trigger point and will be included in the study).
Exclusion criteria:
History of previous neck surgery
History of malignancy in the cervical or thoracic region
Skin disorders in the neck and shoulder area
Fear of needles
Lack of cooperation during treatment
Presence of cognitive impairment
Previous neurological injuries in the upper limb
Hyperreflexia
Patients diagnosed with myelopathy
History of trauma to the neck, thoracic, or shoulder area
Use of anticoagulant medications
Pregnancy or possibility of pregnancy
Presence of rheumatoid conditions
Nerve entrapment in the upper limb or brachial plexus
Possibility of spinal cyst or tumor
Contraindications for electrotherapy
Previous physiotherapy treatment for the same condition within the past month
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the study will be assigned to either the control or intervention group in a 1:1 ratio. To ensure concealment of group assignments, a physiotherapist who is not part of the study will be responsible for randomization. The Random Allocation Software 1.0.0 will be used for this purpose. This software will be instructed to randomly assign 40 patients to intervention and control groups using blocks of 2 and 4. Then, according to the order specified by the randomization software, the letters A and B—representing the intervention and control groups for the therapist—will be written on papers. The individual writing them will not be aware of the group assignments. These papers will then be placed in opaque, numbered envelopes, sealed, and handed over to the intervention therapist. This ensures that the therapist cannot guess the group assignments. During the study, the numbered envelopes will be opened sequentially, determining the group allocation for each incoming patient.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the dry needling technique, it is challenging for the researcher to design the study as double-blind. Therefore, blinding in this study will be single-blind. In this study, the examiner will be blinded to the group assignments, the interventions performed, and the study objectives. To ensure blinding of the examiner regarding the intervention, after the interventions are conducted—whether in the intervention or control group—a matte paper tape will be placed over the targeted trigger point to conceal the needle entry site. This ensures that the examiner remains unaware of whether the dry needling technique has been performed or not.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz,
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2025-05-12, 1404/02/22
Ethics committee reference number
IR.TBZMED.REC.1404.165
Health conditions studied
1
Description of health condition studied
Radiculopathy
ICD-10 code
M47.2
ICD-10 code description
Other spondylosis with radiculopathy
Primary outcomes
1
Description
Pain
Timepoint
Base line, at the beginning and end of each session, and again one month after the treatment.
Method of measurement
NRS
Secondary outcomes
1
Description
Cervical Range of Motion
Timepoint
Before starting the treatment and at the end of the tenth session
Method of measurement
Goniometer
2
Description
Neck Disability
Timepoint
Before starting the treatment and after the final session and one month after the last treatment session
Method of measurement
Neck Disability Index Questionnaire
3
Description
Quality of Life
Timepoint
After the final session and one month after the last treatment session
Method of measurement
SF-36 Questionnaire
4
Description
The Exercise Adherence
Timepoint
After the final session and one month after the last treatment session
Method of measurement
The Exercise Adherence Rating Scale Questionnaire
5
Description
Patient Satisfaction
Timepoint
After the final session and one month after the last treatment session
Method of measurement
Patient Satisfaction Questionnaire
Intervention groups
1
Description
Intervention group: Participants in the intervention group will receive dry needling treatment for the levator scapulae muscle in addition to routine physiotherapy.To perform dry needling in this muscle, the therapist first wears latex gloves on both hands. After disinfecting their hands and the target area with 70% ethanol alcohol, the technique is carried out using a sterile Dong Bang needle from South Korea, measuring 0.3×50 mm.The dry needling technique varies depending on the location of the patient's most painful trigger point: For higher sections of the muscle, the patient lies on their side, and the muscle is pinched. The needle is inserted perpendicularly to the skin, aimed toward the therapist's thumb. For lower sections of the muscle, the patient lies prone with their affected arm placed on their lower back. In the region of the superior angle of the scapula, the needle is inserted at an angle close to the skin surface, directed toward the superior angle of the scapula.The intervention uses a Fast in-Fast out technique, with the goal of eliciting or palpating local twitch responses. The needle motion continues until a twitch response is observed or up to ten repetitions if no response is detected.
Category
Rehabilitation
2
Description
Control group: Participants in the control group will receive only routine physiotherapy treatments for cervical radiculopathy. This treatment begins with High-TENS therapy at 120 Hz frequency with a pulse duration of 60 microseconds, combined with a hot pack for 25 minutes. After that, ultrasound therapy is applied for 4 minutes at 1 MHz frequency with an intensity of 1.6 W/cm². Additionally, manual traction is performed for the cervical region. Neurodynamic techniques based on the Shacklock method, including sliders and tensioners, will be applied according to the patient's needs. Throughout the sessions, routine therapeutic exercises and necessary patient education will be part of the program.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
physiotherapy clinic of Asadabadi hospital
Full name of responsible person
Hakimeh adigozalih
Street address
Asad-Abadi hospital, Bahar avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3280 4293
Email
adigozalih@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Khosro Adibkia
Street address
central building, tabriz university of medical sciences, university street, tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 6923
Email
adibkia@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hakimeh adigozali
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of rehabilitation sciences, Tabriz university of medical sciences,29 Bahman Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 5359
Email
Adigozalih@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hakimeh Adigozali
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy Department, Faculty of Rehabilitation Sciences, Tabriz University of Medical Sciences, 29 Bahman Blv, Tabriz, East Azerbaijan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 5359
Fax
Email
adigozalih@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hakimeh Adigozali
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of rehabilitation sciences, Tabriz university of medical sciences, 29 Bahman Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 5359
Email
Adigozalih@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available