Positional Distraction and Stabilization Exercises in Adults With Lumbar Radiculopathy.

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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Radiculopathy
• Intervention / Treatment: Other: physical therapy treatment

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Dow University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Positional Distraction plus Stabilization Exercise group; The treatment group will receive positional distraction with stabilization exercises	Other: physical therapy treatment; the experimental group received positional distraction plus stabilization exercises and the control group received stabilization exercises only.
ACTIVE_COMPARATOR: Stabilization Exercise group; control group will be treated with stabilization exercises only.	Other: physical therapy treatment; the experimental group received positional distraction plus stabilization exercises and the control group received stabilization exercises only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Investigators: Study Director: IPMR DUHS, Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 10, 2020
• Primary Completion (ACTUAL): December 12, 2020
• Study Completion (ACTUAL): January 25, 2021

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (ACTUAL): June 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 21, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: SKhan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No