Clinical trial NCT04427423: Positional Distraction and Stabilization Exercises in Adults With Lumbar Radiculopathy.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Radiculopathy
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 96
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All the patients will be randomly allocated into treatment and control groups 50 in experimental and 50 in control group. The treatment group will receive positional with stabilization exercises while the control group will be treated with stabilization exercises only.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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 \&gt; 30)

Primary outcomes:
measure: Change from baseline Pain intensity at 8 weeks
timeFrame: All the subjects were assessed before and after 8 weeks of treatment.
measure: Change from baseline Disability at 8 weeks
timeFrame: All the subjects were assessed before and after 8 weeks of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: IPMR DUHS
role: STUDY_DIRECTOR
References: