Spinal Decompression Therapy in Radicular Chronic Low Back Pain

• ClinicalTrials.gov Identifier: NCT04701879
• Recruitment Status: Completed
• First Posted: January 8, 2021
• Last Update Posted: September 5, 2021
• Sponsor: Aqua Medical Services (Pvt) Ltd
• Information provided by (Responsible Party): Mir Arif Hussain, Aqua Medical Services (Pvt) Ltd

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Radiculopathy Lumbar	Other: Spine decompression with core stability exercises; Other: Spine decompression	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Spinal Decompression Therapy With Core Stability Exercises in Radicular Chronic Low Back Pain
• Actual Study Start Date: November 15, 2018
• Actual Primary Completion Date: February 28, 2021
• Actual Study Completion Date: February 28, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Spine decompression with core stability exercises; Interventions in experimental group includes Hot pack, Spinal decompression therapy and core stability exercises	Other: Spine decompression with core stability exercises; 50 minutes per session; Decompression with core stability on alternate days for 8 visits.
Experimental: Spine decompression; Intervention includesHot pack and spinal decompression therapy ..	Other: Spine decompression; 40 minutes per session -Decompression therapy on alternate days for 8 visits.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Pakistan

Aqua research Center

Islamabad, Federal, Pakistan, 44000

Sponsors and Collaborators

Aqua Medical Services (Pvt) Ltd

Investigators

• Principal Investigator: Dr M.Umer Iqbal, MS; Shifa Tameer e milat University

More Information

Publications:

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• Responsible Party: Mir Arif Hussain, Assistant professor, Aqua Medical Services (Pvt) Ltd
• ClinicalTrials.gov Identifier: NCT04701879
• Other Study ID Numbers: REC/-00291 M.Umer
• First Posted: January 8, 2021
• Last Update Posted: September 5, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mir Arif Hussain, Aqua Medical Services (Pvt) Ltd:

Physical therapy; Spinal decompression; Core stability exercises; Radiculopathy Lumbar

Additional relevant MeSH terms:

Radiculopathy; Back Pain; Low Back Pain; Pain; Neurologic Manifestations; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases