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Completed

NCT Number: NCT02699164

Remission of Lumbar Disc Herniation by Physiotherapy

This study was conducted with the aim of determining whether or not Non surgical spinal decompression therapy was effective in remission of herniation, decreasing pain and improving functional status.

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Key information

Conditions

Lumbar Disc Herniation Behavior Bone Diseases Hernia Intervertebral Disc Displacement Motor Activity Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Both groups received combination of electrotherapy, deep friction massage and stabilization exercise for fifteen session.

Combine group received non surgical spinal decompression therapy (NSDT) different from conventional physiotherapy group. Numeric Analog Scale, Straight leg raise (SLR) test, Oswestry Disability Index (ODI) were applied at baseline and after treatment. Disc height and herniation thickness were measured on Magnetic Resonance Imagination (MRI) which performed at baseline and three months after therapy.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

diagnosed as lumbar disc herniation suffering from low back pain at least 8 weeks

Exclusion criteria

undergone any spinal surgery clinical diagnosis of osteoporosis clinical diagnosis of scoliosis and spondylolisthesis any neurological disease causes sensorial loss

Treatment and study plan

DRX 9000, Axiom Worldwide, Tampa, Florida

Device

non-surgical spinal decompression therapy consist 18 traction cycles. Traction force applied herniation levels according to Magnetic Resonance Imaging (MRI).

Physiotherapy

Other

electrotherapy was used. electrotherapy consisted of 20 minutes of hot-pack, 20 minutes of TENS and 5 minutes of ultrasound.

spinal stabilization exercise

Other

spinal stabilization exercises started elementary exercises. According to patient tolerance, exercise program reestablished.

Primary outcomes

  1. herniation thickness

    Time frame: change from baseline in herniation thickness and disc height at three months

    herniation thickness were measured on MRI.

Secondary outcomes

  1. function

    Time frame: up to 3 months

    Oswestry Disability Index was used.Oswestry Disability Index used to assess the changes in function and disability levels. Scores range from 0 to 100.

    scores between 0 and 20 described as "minimal disability", scores between 21and 40 described as "moderate disability",scores between 41and 60 described as "severe disability",scores between 61 and 80 described as "crippled" and scores between 81 and 100 described as " bed bounded"

  2. mobility

    Time frame: up to 3 months

    straight leg raise test was used. Pain free angle of straight leg raise was measured with goniometer.

  3. pain severity

    Time frame: change form baseline in pain severity at 15 sessions of treatment

    numeric analog scale was used. "0" described no pain, "10" described "unbearable pain".

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Lumbal Disk Herniasyonunda farklı Tedavi yöntemlerinin etkinliğinin karşılaştırılması

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2016
Registry last updated
Aug 16, 2016

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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