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IRCT20190327043125N1 IRCT 2019-06-08 Services Hospital Lahore EFFECTS OF SPINAL MANIPULATION ON THORACIC SPINAL PAIN EFFECTS OF SPINAL MANIPULATION VERSUS ROUTINE PHYSICAL THERAPY ON THORACIC SPINAL PAIN;A RANDOMIZED CONTROLLED TRIAL 2640-06-21 anticipated 100 Pending https://irct.ir/trial/39552 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization: Subjects suitable for inclusion will be randomly allocated into two groups; group A/ Experimental group and group B/ control group using coin toss method and allocation sequence will be concealed through sealed envelopes. Concealment of allocation: Allocation concealment will be achieved with sequentially numbered, opaque, sealed, envelopes (SNOSE). SNOSE will be used according to guidelines of Doig and Simpson (25). An independent researcher with no clinical involvement in the trial will make the concealed envelopes. 100 Envelopes will be made. Half envelops will contain folded papers with Treatment A written on them and the remaining half will contain folded papers with Treatment B written on them. A carbon paper will be inserted in each envelop with carbon side facing the paper so the allocation sequence, patient name, date of birth of participant and other information can be transferred onto allocation paper inside the envelope. A piece of tin foil is also inserted into envelop so the treatment card cannot be read against light. Envelops will be sealed and signed by the maker. A unique randomized number will be allocated to these envelops and shuffled vigorously. Then the envelops will be arranged sequentially and handed over to another independent researcher. Assessor will pretest the participant and if eligible envelope will be allocated to subject. Therapist will record the information on the envelope and open it afterwards to maintain the concealment. Assessor will record the post treatment findings and another independent analyst will analyze the data. This allocation of concealment will ensure the unpredictability of treatment allocation by investigators and patients, Blinding description: In these patients assessor will be blinded to allocation of treatment groups in this study. Patient will be blinded to treatment allocation as treatment will be given in separate rooms for each group. Therapist who is not blinded will not take the outcome measurements. 1 Thoracic Spinal Pain effecting Quality of Life. Intervention 1: Intervention group:Subjects in experimental group will be managed with spinal manipulative therapy (a single attempt of high-velocity low-amplitude thrust in prone position) & ergonomic advice.The manipulation technique will be considered successful if an auditory or palpable release is perceived by the therapist and if an improved movement of that joint will be noted on post manipulative motion palpation besides the decrease in pain on visual Analogue Scale. Intervention 2: Control group:Subjects in the control group will be managed with routine physiotherapy (therapeutic exercises of thoracic spinal muscles with three sets of 10 repetitions with the rest period of 30seconds between the sets) and ergonomic advice. 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 depends upon the results
public Dr Ashfaq Ahmed
1-Km Raiwind Road, Lahore
Lahore Pakistan 54000 +92 42 111 865 865 ashfaq.ahmad@uipt.uol.edu.pk The University of Lahore scientific Muhammad Sharif Waqas
jail road lahore
Lahore Pakistan 54000 +92 42 99205517 waqasphysio@gmail.com services Hospital Lahore Pakistan Only patients who will receive a diagnosis of thoracic spine pain from the researcher will be accepted into the study. Diagnosis will be made by questioning and examining the subject .• Age between 40 and 60 years Midline back pain Mobility deficit in thoracic range of motion Pain with compression into spine extension Patients without any known cause of TSP 40 years 60 years Both Patient with neurological signs & symptoms Osteoporosis Severe spinal deformity Any systemic disease e.g. cardiovascular or neurological etc Traumatic history and any other red flags of spinal pain M54.6 Pain in thoracic spine Other Other Intervention group:Subjects in experimental group will be managed with spinal manipulative therapy (a single attempt of high-velocity low-amplitude thrust in prone position) & ergonomic advice.The manipulation technique will be considered successful if an auditory or palpable release is perceived by the therapist and if an improved movement of that joint will be noted on post manipulative motion palpation besides the decrease in pain on visual Analogue Scale Control group:Subjects in the control group will be managed with routine physiotherapy (therapeutic exercises of thoracic spinal muscles with three sets of 10 repetitions with the rest period of 30seconds between the sets) and ergonomic advice. Thoracic spine pain intesity. Timepoint: before and after treatment session and 8 & 12 weeks after treatment. Method of measurement: visual analogue scale to measure pain. Chest expansion. Timepoint: before and after intervention and 8, 12 weeks after intervention. Method of measurement: measuring tape. Range of motion. Timepoint: before and after intervention and 8, 12 weeks after intervention. Method of measurement: goniometer. Quality of Life. Timepoint: before and after intervention and 8, 12 weeks after intervention. Method of measurement: Quality of Life questionnaire. Blood pressure. Timepoint: before and after intervention and 8, 12 weeks after intervention. Method of measurement: digital sphygmomanometer. Heart rate. Timepoint: before and after intervention and 8, 12 weeks after intervention. Method of measurement: pulse oximeter. Services Hospital Lahore Approved 2018-09-20 Ethical committee/Institutional Review Board,The University of Lahore 1-Km raiwin Road Lahore Lahore Punjab Pakistan