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Completed

NCT Number: NCT04701879

Spinal Decompression Therapy in Radicular Chronic Low Back Pain

The study design was randomized control trial and sampling technique was lottery method. After inclusion and exclusion criteria, sample populations were divided into experimental (group A) and control group (group B). Spinal decompression therapy in combination with core stability exercises were given to experimental group as intervention while spinal decompression therapy given alone to the control group. Assessment was taken on after 1st session, 4th session and 8th session of physical therapy intervention. Data were entered and analyzed by SPSS version 21.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aqua research Center

Islamabad, Federal, 44000, Pakistan

About this study

Lower back pain is a common disorder that include any discomfort in the lumbar area below the origin of ribs and above the area of buttocks.Lower back pain with disability is 2nd most often reason for the wastage of time & money.Almost all people suffer from lower back pain at some age of their life .Both genders are effected equally by low back pain. The common problem of lower back pain are when you lift a heavy object prolonged unsupported sitting, accidents, sedentary life style. Sedentary life style could be the cause of low back pain usually when strenuous workout done on weekends as compared to minimal activities on week days. Lumbar area of the back hold and support the weight of the upper body and body do twisting and bending at this area. Specific or non-specific lower back pain is the classifications. Pain caused by any deformity, injury or any physical activity is called non-specific lower back pain.Non-specific lower back pain cannot be having any specific pathology, changes in behavior of movement pattern due to fear avoidance having bad postural control cause this non-specific pain.Lower back pain is one of the general health setbacks globally. It is the leading cause of people's absence from work and limits their activities.Prevalence and burden of low back pain increased with aging.Spinal decompression can create a opposite intradiscal pressure to promote led back of the herniated or bulging disc material and this oppsosity in the disc will cause influx of healing nutrients and other substances into the disc Core stability program improves functional status; reduce pain, increases quality of life and endurance of muscles in lumbar disk herniation patients.A strong core is important to the healthy spine. Abdominal muscle can help the back muscle supporting supine. If core muscle are weak, supine carry extra pressure on your back muscles. For this stabilizing and core exercises are important to strengthen back spine. By increasing endurance of these muscles core muscle should be strong. Core stability program improves functional status; reduce pain, increases quality of life and endurance of muscles in lumbar disk herniation patients.In 2008, a researcher found that stabilization exercises helpful in spinal rehabilitation to prevent from any sports injury. Another study by Hodges in 2003 stated that exercises for central muscle is an developing process; additional work necessary to purify and authenticate move forward, mainly with reference to understand the neurobiology of chronic pain.A study in 2011 on comparison between stabilization plan and Pilates technique for treating Low back pain. Their results showed that, Pereira technique is not is not helpful in get better back pain and function, in comparison with control and lumbar stabilization exercise groups.In exercise plan Mat and gym ball exercise for strength training and step box were used to develop an independent habit of exercise .these exercise plan intend to increase strength of muscle and decrease pain. As a main exercise walking is, safe, suitable and easy to decrease low back pain because it does not involve forceful and twisting forward flexion.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Radicular low back pain with minimum 3 months of duration
  • Both gender ( male and female)
  • Age 20-60 years
  • Limited Straight Leg Raise.

Exclusion criteria

  • With marked bony and soft tissue disease.
  • Less than 20 and more than 60 years of age.
  • Patients who don't have MRI reports

Treatment and study plan

Spine decompression with core stability exercises

Other
  • 50 minutes per session
  • Decompression with core stability on alternate days for 8 visits.

Spine decompression

Other

40 minutes per session

-Decompression therapy on alternate days for 8 visits.

Primary outcomes

  1. The Oswestry Disability Index (ODI)

    Time frame: 0 Day

    The most reliable tool used by the clinicians to determine the functional disability of patients. Now days, the gold standard tool used for functional outcome of lower back is ODI.

  2. The Oswestry Disability Index (ODI)

    Time frame: 4th Day

    The most reliable tool used by the clinicians to determine the functional disability of patients. Now days, the gold standard tool used for functional outcome of lower back is ODI.

  3. The Oswestry Disability Index (ODI)

    Time frame: 8th Day

    The most reliable tool used by clinicians to determine the functional disability of patients. Nowadays, the gold standard tool used for the functional outcomes of the lower back is ODI.

Other outcomes

  1. Numeric pain rating scale

    Time frame: 0 day, 4th day, 8th day

    The NPRS is used as an alternative tool of VAS in which the subject responds to the intensity of pain from 0 to 10. The total number of NPRS is 0 to 10 from which zero is considered as no pain, one to three is considered as mild pain, four to six considered as moderate pain and seven up to 10 considered as severe pain. the patient is guided to score the intensity of pain from zero to ten by own self.

  2. Plank test

    Time frame: 0 day, 4th day, 8th day

    The test used to assess the strength of core muscles is known as plank test. It controls the endurance of the back/core stabilizing muscles. The starting position of the participants is to support the body by their elbows and forearm when off from the ground. The patient is guided to hold this position maximally. The test will be ended if the participants are unable to hold this position and time is noted by stopwatch. Total completed time will be the score to assess the core muscle strength.

Sponsors and collaborators

Lead sponsor

Aqua Medical Services (Pvt) Ltd

Industry

Registry information

Official study title

Effect of Spinal Decompression Therapy With Core Stability Exercises in Radicular Chronic Low Back Pain

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 8, 2021
Registry last updated
Sep 5, 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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