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IRCT20200215046499N5 IRCT 2025-05-29 Tabriz University of Medical Sciences Effect of Levator Scapulae Muscle Dry needling Effect of Levator Scapulae Muscle Dry needling on Clinical Symptom in Patients with Cervical Radiculopathy: A Single Blind Randomized Controlled Trial 2025-07-05 anticipated 40 Complete https://irct.ir/trial/82958 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Radiculopathy. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The release schedule is not yet decided.
public Hakimeh adigozali
Faculty of rehabilitation sciences, Tabriz university of medical sciences,29 Bahman Blvd
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3337 5359 Adigozalih@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Hakimeh Adigozali
Physiotherapy Department, Faculty of Rehabilitation Sciences, Tabriz University of Medical Sciences, 29 Bahman Blv, Tabriz, East Azerbaijan, Iran
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3337 5359 adigozalih@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 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). 18 years 55 years Both 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 M47.2 Other spondylosis with radiculopathy Rehabilitation Rehabilitation 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. 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. Pain. Timepoint: Base line, at the beginning and end of each session, and again one month after the treatment. Method of measurement: NRS. Cervical Range of Motion. Timepoint: Before starting the treatment and at the end of the tenth session. Method of measurement: Goniometer. 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. Quality of Life. Timepoint: After the final session and one month after the last treatment session. Method of measurement: SF-36 Questionnaire. 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. Patient Satisfaction. Timepoint: After the final session and one month after the last treatment session. Method of measurement: Patient Satisfaction Questionnaire. Tabriz University of Medical Sciences Approved 2025-05-12 Ethics committee of Tabriz University of Medical Sciences International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz, Tabriz East Azarbaijan Iran (Islamic Republic of)