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OpenTrials
Completed

NCT Number: NCT04427423

Positional Distraction and Stabilization Exercises in Adults With 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.

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dow University of Health Sciences

Karachi, Sindh, 74200, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

physical therapy treatment

Other

the experimental group received positional distraction plus stabilization exercises and the control group received stabilization exercises only.

Primary outcomes

  1. Change from baseline Pain intensity at 8 weeks

    Time frame: All the subjects were assessed before and after 8 weeks of treatment.

    The pain intensity measured on self reported Visual Analogue Scale. (0 means no pain and 10 is the high intensity of pain).

  2. Change from baseline Disability at 8 weeks

    Time frame: All the subjects were assessed before and after 8 weeks of treatment.

    The disability were assessed on Roland Morris Disability Questionnaire. where 0 means no disability and 24 is the high disability.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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