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IRCT20190618043930N2 IRCT 2023-11-13 The University of Lahore Chronic Cervical Myofascial Pain Syndrome Comparative Effects of Low-Level Laser Acupuncture and Dry Needling on Clinical and Functional Outcomes in Patients with Chronic Cervical Myofascial Pain Syndrome 2023-11-25 anticipated 80 Complete https://irct.ir/trial/72437 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random Allocation Software version 2 will be used for Block randomization design to allocate participants to the groups with an equal sample size over time. The groups will be labeled (E= experimental, C= control). Then a block size of four will chose.So, there will be six possible ways to equally assign participants to a block (EECC, ECEC, ECCE, CEEC, CECE, CCEE). Blocks will be randomly chosen to determine the assignment of all 80 individuals (40 participants in each group). Allocation concealment will be performed using sealed, opaque envelopes, Blinding description: The treatment procedures will be repeated for 3 sessions per week for 6 weeks (18 sessions). The Pre-test, Mid-test & Post-test scores of Numeric Pain Rating Scale, Neck Disability Index, Goniometer and SF-36 Questionnaire will be collected and analysed by an outcome Assessor, who will be kept blind throughout the session in order to reduce any biasing in the study. 2 Myofascial pain syndrome is a frequently encountered musculoskeletal problem characterized by a hypersensitive trigger point. Symptoms of myofascial pain syndrome include pain and increased pain threshold, muscle spasms, and range of motion (ROM) limitation. The symptoms affect quality of life, decrease productivity, reduce work time, and increase the medical expenses borne by the patient. Myofascial pain syndrome frequently occurs in the upper body, with 84% of the trigger points found in the trapezius, scalene, levator scapulae, and infraspinatus muscles. The trapezius muscle is the most frequent site, being involved in 34% of cases. The development of myofascial pain syndrome is related to excessive repetitive activity. Activities that cause muscle tension and fatigue, poor posture, and poor ergonomic work environment are likely to be involved.. Intervention 1: Intervention group:Participants treated by Low-Level Laser acupuncture will be given goggles for eye protection. The trigger points on the Scalene, Levator scapulae and Trapezius muscles will be marked with an 'X' mark. The laser probe (01 cm in diameter) with the power output of 100mv/cm2, the frequency of 9.12 hz that emits a laser beam with 830 nm will be applied directly and perpendicularly into the skin. The irradiation dosage will be 5J/cm2 at each trigger point for Six minutes. The stretching of the Cervical ROM will be done at the end of a session. Intervention 2: Control group: In Dry needling group, while the patient is in prone position, the therapist will wear the surgical gloves, sterilize the area with alcohol pad and use pincer palpation to identify the trigger points. A 25G acupuncture needle (0.3* 30 mm) will be placed on the trigger point to a depth of 2cm. The insertion site will be monitored for local twitch responses (LTRs) for a maximum of 30 minutes with manipulation of the needle until no LTRs will be seen. The needles will be removed and any bleeding that occurre will be controlled. The stretching of the cervical ROM will be done at end of the session. Yes - There is a plan to make this available What will be shared: Consent form, Clinical Study Report, Statistical Plan files can be shared When: 2 months after Publication To whom: People working in academic institutions or people working in businesses can also apply to receive it Conditions: Intervention Purpose Where to obtain: faryal.pt@gmail.com How to obtain: Full description about the purpose/aim of using the documents, Insight about the disorder and Intervention of the research Comments:
public Dr. Faryal Zaidi
1-Km Defence Road, Off Bhobatian Chowk
Lahore Pakistan 54590 +92 42 35322501 faryal.pt@gmail.com The University of Lahore scientific Dr. Faryal Zaidi
1-Km Defence Road, Off Bhobatian Chowk
Lahore Pakistan 54590 +92 42 35322501 faryal.pt@gmail.com The University of Lahore Pakistan Newly diagnosed cases of chronic MyofasciaL Pain Syndrome of Cervical Spine, Patients with at least moderate score (21% - 40%) in Neck Disability Index, Patients with at least >3 points on Numeric Pain Rating Scale, Decreased Cervical Range of Motion up to sixty percent. Bilateral/Unilateral neck pain and Myofascial Trigger Points in upper trapezius, levator scapulae or scalene muscles for at least three months, Taught muscle band and positive Jump Sign on putting finger pressure on the trigger point. 25 years 50 years Both Patients receiving treatment by other methods like vapocoolants, subdural steroid injections etc. Cervical spine surgery within the past year Spondylolisthesis and Ankylosing spondylitis Vascular, neurological or rheumatic disorders Clinical evidence of any myelopathy or joint disorders Recent fracture of the cervical spine Cauda equina syndrome Osteoporosis Fibromyalgia Clinical evidence of any tumor or any space occupying lesion. Any co-morbid diseases M79.12 Myalgia of Auxiliary muscles, head and neck Treatment - Other Treatment - Other Intervention group:Participants treated by Low-Level Laser acupuncture will be given goggles for eye protection. The trigger points on the Scalene, Levator scapulae and Trapezius muscles will be marked with an 'X' mark. The laser probe (01 cm in diameter) with the power output of 100mv/cm2, the frequency of 9.12 hz that emits a laser beam with 830 nm will be applied directly and perpendicularly into the skin. The irradiation dosage will be 5J/cm2 at each trigger point for Six minutes. The stretching of the Cervical ROM will be done at the end of a session. Control group: In Dry needling group, while the patient is in prone position, the therapist will wear the surgical gloves, sterilize the area with alcohol pad and use pincer palpation to identify the trigger points. A 25G acupuncture needle (0.3* 30 mm) will be placed on the trigger point to a depth of 2cm. The insertion site will be monitored for local twitch responses (LTRs) for a maximum of 30 minutes with manipulation of the needle until no LTRs will be seen. The needles will be removed and any bleeding that occurre will be controlled. The stretching of the cervical ROM will be done at end of the session. Pain Intensity. Timepoint: At the start of treatment and then after 9th and 18th treatment session. Method of measurement: Numeric Pain Rating Scale. Functional disability. Timepoint: At the start of treatment and then after 9th and 18th treatment session. Method of measurement: Neck Disability Index. Cervical Range of Motion. Timepoint: At the start of treatment and then after 9th and 18th treatment session. Method of measurement: Goniometer. Quality of Life. Timepoint: At the start of treatment and then after 9th and 18th treatment session. Method of measurement: SF-36 Questionnaire. The University of Lahore Approved 2023-06-19 Board of Advanced Studies and Research, The University of Lahore 1-km Defence Road, Off Bhobatian Chowk Lahore Punjab Pakistan