Compare the Effects of Decompression on Lumber Disc Protrusion Patient

NCT04860609 | Completed

• 1 other identifier: Abdul Ghaffor 00501
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is an RCT study in which 60 participant are included and half of the participant are randomized via lottery method in control and experimental group after fulfilling the inclusion criteria. The sampling technique is convenient sampling . The study compare the effects of conventional Physical Therapy and Decompression Therapy and determine the effectiveness of Decompression as treatment procedure for patients with Lumbar disc protrusion. The data collection procedure included the NPRS, ODI, structural questionnaire and assesment on the 1st, 4th and 8th visit. Data will be analyzed on IBM SPSS-21 {Statistical Procedure of Social Sciences} software. The assessment will be done on 1st, 4th and 8th visits. after checking the normality of the date the Parametric/Non Parametric test will be apply to compare the means of the these groups. The 95% confidence interval will be used in term OD p value 0.05

Conditions

Lumbar Disc Herniation

Keywords

Decompression; Disc herniation; ODI; LBP

Outcome Measures

Primary Outcomes (5)

• Numeric pain rating scale for back

  It is numeric pain rating scale for measuring pain intensity. it ranges from 0-10.In which 0 shows no pain,1-3 (mild pain),4-6(moderate pain) and 10 shows severe pain. As guided by the researcher, pain intensity was marked by the patient

  8th weeks

• Flexion Range of Motion of lumber

  Double inclinometer is used

  8th weeks

• SLR

  Single Inclinometer

  8th weeks

• Side bending Lumber ROm

  Double inclinometer

  8th week

• Extension Lumber ROM

  Double inclinometer is used

  8th week

Study Arms (2)

Conventional Physiotherapy

ACTIVE COMPARATOR

It includes the pre-physiotherapy session by conventional physiotherapy

Other: Conventional Physiotherapy

Lumber spinal decompression

EXPERIMENTAL

It includes the pre-physiotherapy session iby lumber spinal decompression along with conventional therapy.

Other: Lumber Spinal Decompression

Interventions

Conventional Physiotherapy OTHER

The treatment will be given in the following way. 1. Tens 2. Infrared/Moist Heat heat for 10 minutes at low back region. 3. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps 4. Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps 5. Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps 6. Postural Education 7. Home Plan 8. Bed Rest with lumbar Sacral Support 9. Home plan: Exercises Posture Correction Precautions Contra indication

Conventional Physiotherapy

Lumber Spinal Decompression OTHER

The treatment will be given in the following way. 1. Tens 2. Infrared/Moist Heat heat for 10 minutes at low back region. 3. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps 4. Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps 5. Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps 6. Postural Education 7. Home Plan 8. Decompression therapy session lumbar spinal decompression therapy for 30 minutes. 9. Home plan: Exercises Posture Correction Precautions Contra indication

Lumber spinal decompression

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• MRI of lumbar spine showing lumbar disc bulge
• Localized and radiating pain more than 5 on NPRS

You may not qualify if:

• Lumbar spondylolisthesis
• Spinal stenosis
• Fracture of lumbar spine
• Spinal tumor
• Ankylosing spondylitis
• Patients taking blood thinner medication

Sponsors & Collaborators

• Aqua Medical Services (Pvt) Ltd: lead

Study Sites (1)

Abdul Ghaffor Sajjad

Islamabad, Capital, 44000, Pakistan

Location

Related Publications (15)

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  BACKGROUND

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  BACKGROUND

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  PMID: 1387974 BACKGROUND

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  PMID: 2975065 BACKGROUND

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  PMID: 6450452 BACKGROUND

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  BACKGROUND

• Khan, A. G. S. G. A., & Khan, A. (2016). Fascia Stretching Improve the Pain and Functional Level in Disc Protrusion Patients. Journal of Riphah College of Rehabilitaion Sciences, 4(1), 7-10.

  BACKGROUND

• Krause M, Refshauge KM, Dessen M, Boland R. Lumbar spine traction: evaluation of effects and recommended application for treatment. Man Ther. 2000 May;5(2):72-81. doi: 10.1054/math.2000.0235.

  PMID: 10903582 BACKGROUND

• Magee, D. J. (2014). Orthopedic physical assessment: Elsevier Health Sciences. Maitland, G. D., Hengeveld, E., Banks, K., & English, K. (2005). Maitland's vertebral manipulation (Vol. 1): Butterworth-Heinemann.

  BACKGROUND

• Manchikanti L. Epidemiology of low back pain. Pain Physician. 2000 Apr;3(2):167-92.

  PMID: 16906196 BACKGROUND

• Robin, M., & Stephen, M. The lumbar spine mechanical diagnosis & therapy, volume one and two. 2004: Spinal Publications, Nya Zeeland

  BACKGROUND

• van der Windt DA, Simons E, Riphagen II, Ammendolia C, Verhagen AP, Laslett M, Deville W, Deyo RA, Bouter LM, de Vet HC, Aertgeerts B. Physical examination for lumbar radiculopathy due to disc herniation in patients with low-back pain. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD007431. doi: 10.1002/14651858.CD007431.pub2.

  PMID: 20166095 BACKGROUND

• Weber H. Lumbar disc herniation. A controlled, prospective study with ten years of observation. Spine (Phila Pa 1976). 1983 Mar;8(2):131-40.

  PMID: 6857385 BACKGROUND

• Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000 Jun;13(3):205-17. doi: 10.1097/00002517-200006000-00003.

  PMID: 10872758 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Abdul Ghaffor Sajjad, PhD

  Shifa tameer-e-millat university Islamabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mir Arif Hussain

Model Details: control group will recevie conventional physiotherapy sessions while the experimental group receive conventional along with decompression

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 27, 2021
• Study Start: April 21, 2021
• Primary Completion: June 21, 2021
• Study Completion: June 25, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)