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IRCT20200215046499N7 IRCT 2026-04-25 Tabriz University of Medical Sciences Effects of blood flow changes on post-dry needling soreness - Effects of blood flow changes on post-dry needling soreness of the gastrocnemius muscle in patients with myofascial pain syndrome: a single-blinded randomized controlled trial 2026-06-22 anticipated 45 Pending https://irct.ir/trial/87258 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: Participants will be randomly assigned to one of three study groups: Control (A), Treatment 1 (B), or Treatment 2 (C). Random allocation will be performed by an independent individual who is not involved in the research implementation, in order to minimize allocation bias. Randomization will be conducted using a computer-generated random number sequence based on a parallel assignment method with a 1:1:1 allocation ratio. To maintain balance between groups and prevent predictability of assignments, random block sizes of 3, 6, and 9 participants will be used. Each block will contain an equal number of participants in each group, and the sequence of assignments within each block will be determined completely at random. To ensure allocation concealment, opaque, sealed, and sequentially numbered envelopes will be used. Each envelope will be opened only at the time of a participant’s enrollment by the designated study coordinator. Group labels will be coded as A, B, and C. Since outcome assessments will be conducted by an evaluator who is **blinded to group allocation, the study will be designed as a single-blind trial, Blinding description: This study will employ a single-blind design, in which the outcome assessor will be blinded to the group allocation of participants. The random allocation sequence will be generated by an independent researcher and placed in sequentially numbered, opaque, sealed envelopes. After each participant is enrolled in the study, the corresponding envelope will be opened in order to determine group assignment. The outcome assessor, who will remain unaware of the type of intervention received by participants, will perform all evaluations and data recordings. N/A Myofascial pain syndrome. Intervention 1: Intervention group:In this group, the dry needling technique is performed as in the control group. Then, immediately after the dry needling is completed, a moist hot pack with a temperature of about 40-45 degrees is placed directly on the gastrocnemius muscle for 20 minutes. The aim of this action is to increase blood circulation, improve muscle flexibility, and reduce pain in the area. The patient is placed in a comfortable prone position and the compress is covered with a thin towel to prevent direct contact with the skin. The time of 20 minutes for heat therapy has been selected based on previous studies and clinical standards to achieve optimal therapeutic effects such as increased blood circulation. Intervention 2: Intervention group: In this group, dry needling is performed on the gastrocnemius muscle, as in the control group. Immediately after that, the IPOC protocol is performed. For this purpose, a non-digital blood pressure cuff is used on the proximal part of the lower limb to apply arterial occlusion pressure (peak systolic pressure + 50 mmHg) for 5 minutes, then the cuff is completely deflated and the perfusion phase begins, which also lasts 5 minutes. This ischemia-perfusion cycle is repeated 3 consecutive times. A blood pressure cuff with a width of about 15-20 cm will be used to distribute the pressure evenly around the limb and reduce the risk of tissue damage. The peak systolic pressure + 50 mmHg and 3 5-minute cycles have been selected according to studies and clinical standards to prevent damage and achieve optimal therapeutic effects. Intervention 3: Control group:This group receives only dry needling treatment and serves as the control group. To start the treatment, the patient should lie down in a relaxed position. The trigger point location is found using manual touch. To apply the needle, we disinfect the area with cotton soaked in alcohol. Acupuncture needles (Dong bang Acuprime Ltd, with dimensions: 2.5mm*50mm, Korea) are applied to the trigger point using the dry needling technique. The needle, which is held with the dominant hand, is quickly inserted into the trigger point according to the Hong method and a local twitch response is observed. Then the needle is pulled out but not removed from the skin and re-entered into the trigger point. This is repeated until no local twitch response is observed after 10 needle movements. When examining and determining the exact location of the trigger points, if there is more than one painful point, the point that causes the most pain is evaluated and treated. This point is marked to remain constant throughout the process. 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 There is no further information.
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) Patients aged 20 to 45 years Presence of primary pain in the calf muscles Initial pain intensity between 3 and 8 on the Numeric Pain Rating Scale (NPRS) during initial assessment Presence of an active trigger point in the lateral head of the gastrocnemius muscle on the affected side Individuals with a BMI between 18 and 27 20 years 45 years Both History of recent surgery in the lower limb History of trauma in recent years Physiotherapy treatment within the past six months Presence of cardiovascular diseases or thrombosis Diabetes mellitus and hypertension Fibromyalgia syndrome, diagnosed by a specialist physician and confirmed by the therapist through palpation of the related tender points Skin injury, infection, or inflammatory edema at the site of the trigger point at the time of testing Pregnancy at the time of testing Use of sedative or anticoagulant medications before or during the treatment Needle phobia Possibility of any systemic inflammation (due to malignancy, common cold, infection, or any other condition associated with inflammatory factors in the blood) G89.4 Chronic pain syndrome Rehabilitation Rehabilitation Rehabilitation Intervention group:In this group, the dry needling technique is performed as in the control group. Then, immediately after the dry needling is completed, a moist hot pack with a temperature of about 40-45 degrees is placed directly on the gastrocnemius muscle for 20 minutes. The aim of this action is to increase blood circulation, improve muscle flexibility, and reduce pain in the area. The patient is placed in a comfortable prone position and the compress is covered with a thin towel to prevent direct contact with the skin. The time of 20 minutes for heat therapy has been selected based on previous studies and clinical standards to achieve optimal therapeutic effects such as increased blood circulation. Intervention group: In this group, dry needling is performed on the gastrocnemius muscle, as in the control group. Immediately after that, the IPOC protocol is performed. For this purpose, a non-digital blood pressure cuff is used on the proximal part of the lower limb to apply arterial occlusion pressure (peak systolic pressure + 50 mmHg) for 5 minutes, then the cuff is completely deflated and the perfusion phase begins, which also lasts 5 minutes. This ischemia-perfusion cycle is repeated 3 consecutive times. A blood pressure cuff with a width of about 15-20 cm will be used to distribute the pressure evenly around the limb and reduce the risk of tissue damage. The peak systolic pressure + 50 mmHg and 3 5-minute cycles have been selected according to studies and clinical standards to prevent damage and achieve optimal therapeutic effects. Control group:This group receives only dry needling treatment and serves as the control group. To start the treatment, the patient should lie down in a relaxed position. The trigger point location is found using manual touch. To apply the needle, we disinfect the area with cotton soaked in alcohol. Acupuncture needles (Dong bang Acuprime Ltd, with dimensions: 2.5mm*50mm, Korea) are applied to the trigger point using the dry needling technique. The needle, which is held with the dominant hand, is quickly inserted into the trigger point according to the Hong method and a local twitch response is observed. Then the needle is pulled out but not removed from the skin and re-entered into the trigger point. This is repeated until no local twitch response is observed after 10 needle movements. When examining and determining the exact location of the trigger points, if there is more than one painful point, the point that causes the most pain is evaluated and treated. This point is marked to remain constant throughout the process. Muscle sorness. Timepoint: Immediately after, 48 hours and one week after receiving the intervention. Method of measurement: The Numerical Pain Rating Scale, as well as measurements of blood inflammatory factors, used to determine muscle soreness caused by the needle. Pain pressure treshold. Timepoint: Before, immediately after, 48 hours and one week after receiving the intervention. Method of measurement: In this study, an algometer was used to press on a trigger point located on the lateral head of the gastrocnemius muscle, and the pressure at which the patient first reports a pain sensation was considered the pressure pain threshold. Functional disability. Timepoint: Before and one week after receiving the intervention. Method of measurement: In this study, the Persian equivalent version of the Lower Extremity Functional Scale (LEFS) questionnaire was used to assess the level of lower extremity functional disability in the treatment groups. Muscle blood flow. Timepoint: Before, immediately after, and 48 hours after receiving the intervention. Method of measurement: In this study, blood flow around the trigger point in the lateral head of the gastrocnemius muscle was calculated using a linear probe by measuring the maximum systolic velocity, minimum diastolic velocity, and vascular resistance index in the posterior tibial artery using a Doppler ultrasound device. Muscle thickness. Timepoint: Before the intervention, immediately after and 48 hours later. Method of measurement: In this study, a B-Mode image is taken of the muscle at rest and contraction states using an ultrasound device and a linear probe. The probe is placed on the lateral gastrocnemius muscle and parallel to the muscle fibers. The maximum horizontal distance between the two hyperechoic fasciae on both sides of the muscle is recorded as the muscle thickness. Blood inflammatory factors. Timepoint: The first sample is collected before the intervention and the second sample is collected 48 hours after the intervention. Method of measurement: To assess gastrocnemius muscle tissue irritation after dry needling, serum C-reactive protein and creatine kinase levels are measured through a blood test. Dorsiflexion range of motion. Timepoint: Before, immediately after, 48 hours and one week after receiving the intervention. Method of measurement: Ankle dorsiflexion range of motion is measured by bringing the ankle close to the shin and using a goniometer. The fixed probe of the goniometer is placed on the shin and the movable probe is placed on the dorsum of the foot. Pain. Timepoint: Before, 48 hours after, and one week after receiving the intervention. Method of measurement: The NPRS scale is used to determine the patient's initial pain intensity (not the pain from dry needling) before, immediately after, 48 hours after, and one week after the intervention. Tabriz University of Medical Sciences Approved 2026-02-09 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)