Positional Distraction and Stabilization Exercises in Adults With Lumbar Radiculopathy.

NCT04427423 | Completed DMC

• 1 other identifier: SKhan
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Radiculopathy

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Positional Distraction plus Stabilization Exercise group

EXPERIMENTAL

The treatment group will receive positional distraction with stabilization exercises

Other: physical therapy treatment

Stabilization Exercise group

ACTIVE COMPARATOR

control group will be treated with stabilization exercises only.

Other: physical therapy treatment

Interventions

physical therapy treatment OTHER

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

Positional Distraction plus Stabilization Exercise group; Stabilization Exercise group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 74200, Pakistan

Location

Related Publications (1)

• Khan S, Hasnain F, Soomro RR, Rehmani A. Comparison of positional distraction with stabilisation exercises versus stabilisation exercises alone in the management of lumbar radiculopathy: A randomized controlled-trial. J Pak Med Assoc. 2024 Jan;74(1):5-9. doi: 10.47391/JPMA.6540.

  PMID: 38219156 DERIVED

MeSH Terms

Conditions

Radiculopathy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• IPMR DUHS

  Dow University of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients were blinded from the treatment groups that either he/she are in experimental or control group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: June 11, 2020
• Study Start: April 10, 2020
• Primary Completion: December 12, 2020
• Study Completion: January 25, 2021
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)