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IRCT20190325043109N1 IRCT 2019-06-30 The University Of Lahore Effectiveness of Neuromobilization in neck pain Effectiveness of Neuromobilization on Pain,Range of motion,Muscle Endurance and Disability in Cervical Radiculopathy,A Randomized Controlled Trial 2640-06-22 anticipated 88 Pending https://irct.ir/trial/39551 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Randomization: Randomization sequence will be created by using Excel 2016 with a 1:1 allocation using simple randomization by an independent researcher who will not be participating in treatment of patients. Patients will be allocated to two groups by concealment of allocation 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 26. An independent researcher with no clinical involvement in the trial will make the concealed envelopes. 88 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. 28 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: Blinding: In this study patients, assessors, data analysts will be blinded to allocation of treatment groups in this study. Except for the therapist all other staff will be kept blinded as they will not be informed about the details of allocation. Trial will be adhered to established procedures to maintain separation between staff who will collect outcome measurements and the therapist. 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. All the other assessors, investigators and analysts will not know the details of treatment. 1 Patients suffering from cervical rediculopathy leading decrease their input in all type of activities they are unable to coop with their daily routine due to pain and decrease range of motion their quality of life impaired.. Intervention 1: Intervention group: Group A (Experimental group): In group A neural mobilization technique with sliding of median nerve will be applied with 3 seconds hold in each repetition, Neural mobilization will be done according to technique described by David Butler. Subject will be placed in supine position and slider neural mobilization of the median nerve will be given.In this group conservative treatment which will include cervical isometrics exercises with 10 repetitions in each direction with 5 seconds hold will also be given. Isometric exercises will be performed with the patient in sitting position. Intervention 2: Control group: Group B (control group): In group B conservative treatment will be given which will include cervical isometrics exercises with 10 repetitions in each direction with 5 seconds hold will also be given. Isometric exercises will be performed with the patient in sitting position 3 sets of these exercises will be performed with the rest period of 30seconds. All the subjects will be given hot packs for 10 minutes prior to the treatment. Yes - There is a plan to make this available What will be shared: EFFECTIVENESS OF NEURO MOBILIZATION ON PAIN, RANGE OF MOTION, MUSCLE ENDURANCE AND DISABILITY IN CERVICAL RADICULOPATHY: A RANDOMIZED CONTROLLED TRIAL. When: Data will be available when my Ph.D Study completed To whom: For academic institutions only Conditions: People who will request for data Where to obtain: Through email address How to obtain: My email address Comments: N/A
public Umair Ahmed
Wapda Town
Lahore Pakistan 53720 N/A umairahmedpt@gmail.com The University Of Lahore scientific Shazia Rafiq
Near Neela Gumband Anarkali Bazar
Lahore Pakistan 53720 +92 42 99200600 shazesarfraz@gmail.com Mayo Hospital Lahore Pakistan Age group between 35-50 years Gender both male and female Subjects having radiating symptomsof cervical radiculopathy Subjects with no previous cervical surgeries Subjects with no loss of the upper limb movement 35 years 50 years Both Subjects having traumatic history Subjects with Osteoporosis Hypermobile patients Subjects with circulatory disturbances Subjects with peripheral nerve entrapment Subjects with tumor causing cervical radiculopathy Patients who are not willing to be included in the study. M50.1 Cervical disc disorders Treatment - Other Other Intervention group: Group A (Experimental group): In group A neural mobilization technique with sliding of median nerve will be applied with 3 seconds hold in each repetition, Neural mobilization will be done according to technique described by David Butler. Subject will be placed in supine position and slider neural mobilization of the median nerve will be given.In this group conservative treatment which will include cervical isometrics exercises with 10 repetitions in each direction with 5 seconds hold will also be given. Isometric exercises will be performed with the patient in sitting position. Control group: Group B (control group): In group B conservative treatment will be given which will include cervical isometrics exercises with 10 repetitions in each direction with 5 seconds hold will also be given. Isometric exercises will be performed with the patient in sitting position 3 sets of these exercises will be performed with the rest period of 30seconds. All the subjects will be given hot packs for 10 minutes prior to the treatment Pain. Timepoint: Pre assessment will be done at baseline, second assessment will be done after 2 weeks and final post assessment will be done at the end of 12th session in 4th week. Method of measurement: Pain by Visual analogue scale. Range of motion. Timepoint: Pre assessment will be done at baseline, second assessment will be done after 2 weeks and final post assessment will be done at the end of 12th session in 4th week. Method of measurement: Range of motion will be measured by Inclinometer. Muscle endurance. Timepoint: Pre assessment will be done at baseline, second assessment will be done after 2 weeks and final post assessment will be done at the end of 12th session in 4th week. Method of measurement: By Cranio Cervical flexion test. Neck Disability. Timepoint: Pre assessment will be done at baseline, second assessment will be done after 2 weeks and final post assessment will be done at the end of 12th session in 4th week. Method of measurement: Neck disability index. Quality of life. Timepoint: Pre assessment will be done at baseline, second assessment will be done after 2 weeks and final post assessment will be done at the end of 12th session in 4th week. Method of measurement: SF 36 Questionnaire. The University Of Lahore Approved 2639-11-11 Institutional Review Board,University of Lahore Raiwind Road Lahore Punjab Pakistan