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IRCT20221106056422N1 IRCT 2023-01-29 Semnan University of Medical Sciences The comparative effect of Kinesio Taping method and Dry needling technique in plantar fasciitis The comparative effect of Kinesio Taping method and Dry needling technique on pain, performance and plantar fascia thickness in patients with plantar fasciitis 2023-02-20 anticipated 45 Complete https://irct.ir/trial/66821 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple non-probability sampling will be used in this study. The allocation of individuals to the three groups will be performed through random allocation and for such purpose the Block randomization will be used. This clinical trial study including 45 samples that will be randomly allocated in three groups (one group is control and two other groups are intervention1 and 2). The therapist divides subjects into subgroups called blocks with size of 3. Individuals in each block are randomly divided into three groups: control (C), treatment1(T1) and treatmet2 (T2). Hence we have a combination of control and treatment blocks as (T2T1C, T1T2C, T1CT2, CT2T1, و CT1T2, T2CT1). finally we randomly select 15 blocks using excel computer software. therefore we have had 45 subjects that in each groups will be 15 subjects. The number of blocks and how they are executed are done by hiding them inside the envelope. In this method, the blocks are numbered based on a random sequence and are placed inside the envelopes, and the researcher assigns them to the intervention and treatment groups based on the order of arrival of the patients, Blinding description: This study is Single-blind. Outcome assessor and analyzer will be blind and will not be aware from grouping. Groups will be available to analyzer and outcome assessor as A, B and C . N/A Plantar fasciitis. Intervention 1: Intervention group 1: Dry needling of plantar fascia: Routine physiotherapy interventions including ultrasound with 3 MHz intensity (for 5 minutes for the painful point of plantar fascia), low frequency TENS with 120 Hz frequency and 40 milli seconds duration ( for 15 minutes to the same painful spot) are applied for people with plantar fasciitis (15 people) before applying dry needling.This technique is performed twice a week for two consecutive weeks, while the patient is in prone position, the skin is cleaned and 15 stainless steel needles with a length and diameter of 0.25 x 40 millimeter are inserted into the plantar fascia, which is considered the most painful area in plantar fasciitis. The needles are guided 0.5 to 1.5 cm through the skin and fascia, and are applied with consecutive strokes and keeping the needle in place for 10 minutes and rotating 3-4 times.This rotation method is repeated twice in each step. After the needles are removed, the needle insertion sites are tightly compressed to prevent bleeding. Intervention 2: Intervention group 2: Plantar fascia kinesiotape: Routine physiotherapy interventions including ultrasound with 3 MHz intensity (for 5 minutes for the painful point of plantar fascia), low frequency TENS with 120 Hz frequency and 40 milliseconds duration (for 15 minutes for the same painful point) is applied for people with plantar fasciitis (15 people) before applying kinesiotape . To perform kinesiotape, Tex Tape with 25% tension is used for plantar fascia. Tapping is used for patients twice a week for two weeks. During tape application, the patient is placed in prone position, and the knee joints are placed in 90 degree flexion and the ankle joints are placed in a normal position. The strip is cut longitudinally into four slices of equal width. The strip is marked on the Achilles tendon or the dorsal border of the calcaneus. Four spots are identified on the first to fifth metatarsals joints, except the third metatarsal joint. Finally, it is applied by the space correction method, with 25% stretching of the forefoot. The initial length of the tape will be approximately half the length of the foot, measured from the end of the heel to the tip of the big toe. Intervention 3: Control group: routine physiotherapy: Routine physiotherapy is performed 5 days a week for two weeks for people with plantar fasciitis (15 people). Routine physiotherapy interventions include ultrasound therapy and low frequency TENS for plantar fascia. Ultrasound with 3 MHz intensity and for 5 minutes is applied to the painful point of the plantar fascia. Low frequency TENS with 120 Hz frequency and 40 milliseconds duration is applied for 15 minutes to the same painful point. 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 Maryam Mokhtari
No.19, Abmorad street
Cholicheh Iran (Islamic Republic of) 88671-87930 +98 38 3326 7355 maryam.mokhtari444@gmail.com Semnan University of Medical Sciences scientific Maryam Mokhtari
No.19, Abmorad street
Cholicheh Iran (Islamic Republic of) 88671-87930 +98 38 3326 7355 maryam.mokhtari444@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Plantar fasciitis Heel pain with the most tenderness in the medial tubercle of foot Pain more than 3 months in the medial tubercle Pain level at least 3 in visual analog scale Pain with first step in the morning or after a long period of rest Experience of pain despite other conservative methods (eg, silicone insoles, nonsteroidal anti-inflammatory drugs, and exercise) Without cognitive disorder and consciousness disorder The thickness of the fascia is more than 4 mm Sign the consent form Age between 18-60 years 18 years 60 years Both Positive sign of sciatica in sciatica nerve test Allergic to kinesiotape Medical diagnosis of gout, diabetic neuropathy, rheumatoid arthritis, lupus, cancer and infection Allergic or fear of dry needles (DN) Presence of peripheral arterial vascular disease Pregnancy Plantar heel pain treatment with DN or acupuncture in last 4 weeks History of heart diseases History of corticosteroid injection in the heel in the last 3 months History of chemotherapy in the last six months Heel spur Plantar hyper hydrosis Hyper activity Skin disease M72.8 Other fibroblastic disorders Treatment - Other Treatment - Other Treatment - Other Intervention group 1: Dry needling of plantar fascia: Routine physiotherapy interventions including ultrasound with 3 MHz intensity (for 5 minutes for the painful point of plantar fascia), low frequency TENS with 120 Hz frequency and 40 milli seconds duration ( for 15 minutes to the same painful spot) are applied for people with plantar fasciitis (15 people) before applying dry needling.This technique is performed twice a week for two consecutive weeks, while the patient is in prone position, the skin is cleaned and 15 stainless steel needles with a length and diameter of 0.25 x 40 millimeter are inserted into the plantar fascia, which is considered the most painful area in plantar fasciitis. The needles are guided 0.5 to 1.5 cm through the skin and fascia, and are applied with consecutive strokes and keeping the needle in place for 10 minutes and rotating 3-4 times.This rotation method is repeated twice in each step. After the needles are removed, the needle insertion sites are tightly compressed to prevent bleeding. Intervention group 2: Plantar fascia kinesiotape: Routine physiotherapy interventions including ultrasound with 3 MHz intensity (for 5 minutes for the painful point of plantar fascia), low frequency TENS with 120 Hz frequency and 40 milliseconds duration (for 15 minutes for the same painful point) is applied for people with plantar fasciitis (15 people) before applying kinesiotape . To perform kinesiotape, Tex Tape with 25% tension is used for plantar fascia. Tapping is used for patients twice a week for two weeks. During tape application, the patient is placed in prone position, and the knee joints are placed in 90 degree flexion and the ankle joints are placed in a normal position. The strip is cut longitudinally into four slices of equal width. The strip is marked on the Achilles tendon or the dorsal border of the calcaneus. Four spots are identified on the first to fifth metatarsals joints, except the third metatarsal joint. Finally, it is applied by the space correction method, with 25% stretching of the forefoot. The initial length of the tape will be approximately half the length of the foot, measured from the end of the heel to the tip of the big toe. Control group: routine physiotherapy: Routine physiotherapy is performed 5 days a week for two weeks for people with plantar fasciitis (15 people). Routine physiotherapy interventions include ultrasound therapy and low frequency TENS for plantar fascia. Ultrasound with 3 MHz intensity and for 5 minutes is applied to the painful point of the plantar fascia. Low frequency TENS with 120 Hz frequency and 40 milliseconds duration is applied for 15 minutes to the same painful point. Plantar fascia thickness in patient with Plantar fasciitis. Timepoint: The measurement of the thickness of the plantar fascia is done at the beginning of the study (before the start of the intervention) and 2 and 4 weeks after the start of the interventions. Method of measurement: To measure the plantar fascia thickness, an ultrasound machine model HS2100 made in Japan with a frequency of 12 MHz and a linear probe of 4.5 cm is used. The transducer of the ultrasound device is placed in the sagittal plane on the inner band of the plantar fascia at the junction with the inner prominence of the heel, and the thickness of the plantar fascia is measured. Pain score in patient with Plantar fasciitis. Timepoint: The measurement of pain score is done at the beginning of the study (before the start of the intervention) and 2 and 4 weeks after the start of the interventions. Method of measurement: The basis of pain is based on the visual analog scale that is used to measure and grade pain in patients. In general, this scale is drawn as a 100 mm or 10 cm line, and the amount of pain is rated between 0 and 10.The two ends of the scale include the number zero at the left which indicates no pain (zero = no pain) and the number 10 at the right end indicates the most pain. The number 1 to 3 indicates mild pain, the number 4 to 6 indicates moderate pain, and the number 7 to 10 indicates severe pain. The patient marks his pain score with a vertical line on the scale. Performance score in patient with Plantar fasciitis. Timepoint: The measurement of performance score is done at the beginning of the study (before the start of the intervention) and 2 and 4 weeks after the start of the interventions. Method of measurement: The Foot and Ankle Outcome Score (FAOS) questionnaire is used to evaluate performance in this research. This questionnaire is designed to evaluate symptoms and functional limitations related to the foot and ankle. This questionnaire asks for patient's ankle problem and helps to know how the patient feels about his ankle and to what extent he is able to perform his usual activities. It has five subscales: pain, symptoms (stiffness, swelling, crepitus, and movement limitation), performance in activities of daily living (ADL), performance in sports, and quality of life (QoL). Scores of 0 and 100 represent severe and asymptomatic symptoms, respectively. Semnan University of Medical Sciences Approved 2022-10-24 Ethics committee of semnan University of Medical Sciences Headquarter of Semnan University of Medical Sciences and Health Services, Basij Blvd, Semnan, Iran. Semnan Semnan Iran (Islamic Republic of)