Positional Distraction and Stabilization Exercises in Adults With Lumbar Radiculopathy.

Lumbar Radiculopathy Clinical Trial

Official title:

Experimental-controlled, Randomized, Single Blind Trial of Effectiveness of Positional Distraction With Stabilization Exercises Versus Stabilization Exercises Alone in the Management of Lumbar Radiculopathy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04427423
• Other study ID #: SKhan
• Status: Completed
• Phase: N/A
• Start date: April 10, 2020
• Est. completion date: January 25, 2021

Study information

• Verified date: February 2021
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluate the addition of positional distraction to stabilization exercises in the treatment of lumbar radiculopathy in adults. Half of the patients will recieve positional distraction and stabilization exercises in combination, while the other half will recieve stabilization exercises only.

Description:

In positioanl distraction making use of the body position to produce traction at an isolated spinal level to maximally open the affected neuroforamen. It is an alternative to lumbar mechanical traction.

The spinal level of vertebral level requiring traction is palpated and a soft roll is placed and the patient side lies on the unaffected side. For further distraction both hips are flexed until movement is noted at the spinal level needing traction.

Further, distraction applied by rotating upper trunk to opposite side of pain.

Stabilization exercises are mainly used for the stability of joints and for improving muscle strength.

The first step of lumbar stabilization exercises are to maintain functional back positions during all activities. The second step is to improve strength and endurance of the core muscles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: January 25, 2021
• Est. primary completion date: December 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of lumbar radiculopathy

• Age limit 30-50 years

• Both males and females

• Pain history more than 12 weeks but less than one year

• Patient having lumbar disc bulge at maximum two adjacent levels

Exclusion Criteria:

• Any type of tumor and infection in the spine

• Spondylolisthesis at L4- L5, L5-S1

• Fracture of the lumbar spine

• Sciatica other than lumbar region (piriformis syndrome)

• Acute cardiopulmonary conditions

• Morbid obesity (BMI > 30)

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Radiculopathy

Intervention

Other:
• physical therapy treatment
the experimental group received positional distraction plus stabilization exercises and the control group received stabilization exercises only.

Locations

Country	Name	City	State
Pakistan	Dow University of Health Sciences	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Pain intensity at 8 weeks	The pain intensity measured on self reported Visual Analogue Scale. (0 means no pain and 10 is the high intensity of pain).	All the subjects were assessed before and after 8 weeks of treatment.
Primary	Change from baseline Disability at 8 weeks	The disability were assessed on Roland Morris Disability Questionnaire. where 0 means no disability and 24 is the high disability.	All the subjects were assessed before and after 8 weeks of treatment.