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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05955781
Other study ID # FUI/CTR/2023/13
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 15, 2023
Est. completion date February 10, 2024

Study information

Verified date July 2023
Source Foundation University Islamabad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will be a Randomized Control Trial in which Both Genders with Age between 20 to 50 Years who had diagnosed with lumbar radiculopathy will be recriuted in to two groups.group A will be recieving spinal mobilzation with leg movement along with TENS & hot pack.whie group B will be given only spinal mobilization with TENS & hot pack.before and after the introduction of interventions pain,disabaility,speed of gait,cadence and SLR will be checked before and after the treatment


Description:

Lumbar Radiculopathy is a medical condition that occurs when one or more nerve roots in the spinal cord are compressed or damaged, leading to pain, weakness, numbness or tingling sensations in the affected area of the body. This condition can be caused by herniated discs, spinal stenosis, Degenerative disc disease, tumors and infections.This study will be a Randomized Control Trial.The study will be conducted in district Swabi. We will recruit the data from NCS University Rehabilitation Centre Swabi.oswestry disbaility index will be given at the start of study and NPRS to check their pain and disbaility levels.SMWLM will be given to experimental group.Participants will be given Hot pack for 15 minutes, TENS for 10 minutes.The patient receives a set of three repetitions, then three sets of six repetitions, with a 30-second break in between each set of treatments. In this session, a progression was also provided as free SLR overpressure. A total of 6 sessions will be given thrice a week on alternate days for 2 consecutive weeks. The treatment will be given with 5 repetitions of SMWLM and 10 repetitions of spinal mobilization with three sets of transverse glide. Total time duration of the treatment will be around 25-35 minutesĀ§ Pre assessment will be conducted at baseline followed by intervention for 3 days per week for 6 consecutive weeks.Final assessment will be conducted at the end of 6 weeks of intervention


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 44
Est. completion date February 10, 2024
Est. primary completion date September 20, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - Patients diagnosed with lumbar Radiculopathy with unilateral radiating leg pain. - Both Genders with Age between 20 to 50 Years. - Patient willing to participate and complete their follow-ups. - Pain from (0-35 degrees) in Straight Leg Raise(Dural Pain). - Positive neurodynamic test i.e. SLR test(35-70 degrees),which indicate sciatica) - Pain more 3-5 or More on NPRS. Exclusion Criteria: - Spinal stenosis. - Cauda equina syndrome. - Patients having Somatic referred pain. - Specific diseases of spine like ankylosing spondylitis, ,vertebral collapse, Rheumatoid arthritis, and Spondylolisthesis. - Tb spine, intermittent claudication,diabetic neuropathy. - Recent infection. - Mental retardation. - Previous spinal Surgery. - Pelvis Fracture.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Spinal Mobilization With Leg Movement
spinal mobilization with leg movement is the intervention given to experimental group. This technique involves applying pressure to the relevant spinous process while the patient moves their limb through the previously restricted range of motion. It is assumed that the restriction of movement is due to a spinal issue but it does not always indicate nerve damage as spinal movement is necessary for limb movement beyond a certain point. The goal is to address any spinal mechanical limitations and there may also be potential effects on the nerves.
Spinal Mobilization
The patients will be given Spinal mobilization transverse glide(kaltenborn glide) on the effected spinous process. The total time duration will be 25-30 minutes.
Conventional treatment
Participants will be given Hot pack for 15 minutes, TENS for 10 minutes

Locations

Country Name City State
Pakistan NCS University Rehabilitaion Centre Swabi Swabi KPK

Sponsors (1)

Lead Sponsor Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain severity Pain will be measured using Numeric Pain Rating Scale which is an eleven point scale scored from 0 indicating no pain and 10 indicating worst pain 2 weeks
Secondary Straight leg raise Goniometer is a manual scale use for measuring the range of motion of a joint. In this scale degree varies from 0-360 angle 2 weeks
Secondary Lumbar Disability Lumbar disability will be measured using Oswestry Disability Index which is a valid and reliable tool consisting of 10 items from which patient gets to choose according to their level of function 2 weeks
Secondary Cadence 10 METER WALK TEST: Initial 2 meters of the gait and final 2 meters of the gait will be for acceleration and deceleration. And the patient is then asking to walk and will assess the cadence and speed. 2 weeks
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