Patient Specific 3-Dimensional And 2-Dimensional Lumbar Traction In Patients With Lumbar Radiculopathy

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05356689
Collaborator
(none)
26
1
2
13
2

Study Details

Study Description

Brief Summary

The aim of study will be comparative effectiveness of the 2d and 3d lumbar traction on pain and functional disability in lumbar radiculopathy. This study will be useful for the physiotherapists to know which traction equipment will be more effective for the treatment of the lumbar radiculopathy

Condition or Disease Intervention/Treatment Phase
  • Other: mechanical traction
N/A

Detailed Description

In one studied the effect of patient-specific three-dimensional lumbar traction on pain and functional disability in individuals with lumbar intervertebral disc prolapse. Twenty-five participants (age range: 34-67 years) diagnosed with lumbar intervertebral disc prolapse were included in this study. Patient-specific three-dimensional lumbar traction was given as three sessions per week for the duration of one month. All participants completed a 10-cm visual analog pain scale and pain pressure threshold to assess pain and the Oswestry disability index to assess the functional disability. Twelve sessions of patient-specific three-dimensional lumbar traction promoted a reduction in pain and improvement in functional disability among subjects with lumbar intervertebral disc prolapse.Another studied to evaluate the effectiveness of traction in improving low back pain, functional outcome, and disk morphology in patients with herniated intervertebral disks. They included randomized control trials which involved adult patients with low back pain associated with herniated disk confirmed by magnetic resonance imaging or computed tomography, compared lumbar traction to sham or no traction, and provided quantitative measurements of pain and function before and after intervention. Methodological quality was assessed using the physiotherapy evidence database (Pedro) scale and Cochrane risk of bias assessment. Compared with sham or no traction, lumbar traction exhibited significantly more pain reduction and functional improvements in the short term, but not in the long term.

In Pakistan most of the physiotherapists used the two-dimensional traction bed for lumbar traction. There is insufficient study on Three-dimensional Traction unit. And there is no literature review is available on comparison of the 2d and 3d traction. To the best of researcher's knowledge, it can be concluded that insufficient literature is available on th

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Comparative Effects Of Patient Specific 3-Dimensional And 2-Dimensional Lumbar Traction On Pain And Functional Disability In Patients With Lumbar Radiculopathy
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: traditional physiotherapy

Common Treatment: Hot pack (for 10 minutes), and US 1mhz for 7 minutes, Mackenzie exercises and cold pack will applied for 15 minutes after traction.

Other: mechanical traction
Group A: This group will get 3-dimensional lumbar traction on multi-dimensional traction bed spine MT. Group B: This group will get 2-dimensional lumbar traction on 2-dimensional traction bed. Common Treatment: Hot pack (for 10 minutes), and US 1mhz for 7 minutes, Mackenzie exercises and cold pack will applied for 15 minutes after traction.
Other Names:
  • core strengthening
  • Experimental: 3- 2dimensional lumbar traction

    Group A: This group will get 3-dimensional lumbar traction on multi-dimensional traction bed spine MT. Group B: This group will get 2-dimensional lumbar traction on 2-dimensional traction bed.

    Other: mechanical traction
    Group A: This group will get 3-dimensional lumbar traction on multi-dimensional traction bed spine MT. Group B: This group will get 2-dimensional lumbar traction on 2-dimensional traction bed. Common Treatment: Hot pack (for 10 minutes), and US 1mhz for 7 minutes, Mackenzie exercises and cold pack will applied for 15 minutes after traction.
    Other Names:
  • core strengthening
  • Outcome Measures

    Primary Outcome Measures

    1. Numerical Pain Rating Scale (NPRS) [10 months]

      Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain". NPRS have shown high test-retest reliability (r = 0.96 and 0.95, respectively)

    2. Oswestry Disability Index (ODI) [10 months]

      The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Both male & female participants

    • Age group between 30 to 65 yrs.

    • Participants having chronic radiating pain in one or both legs will be included.

    • Patients having history of low back ache for 30 days in last six months.

    • Minimum of 25 score out of 100, on low back pain index

    • Participants suffering from intervertebral disc prolapse diagnosed by Orthopedic Surgeon or Experienced Physiotherapist

    Exclusion Criteria:
    • Participants having contraindication to spinal manipulative therapy. 18

    • Participants having disorders of autoimmune nature,

    • Participants having neurodegenerative diseases,

    • Participants having organic referred pain,

    • Participants having pregnancy,

    • participant with history of back surgery

    • History of cancer /metastasis

    • participant having medications periodically

    • participant suffering from psychological conditions

    • participants with history of inflammatory joint disease arthritis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Life Line Hospital Lahore Punjab Pakistan 38000

    Sponsors and Collaborators

    • Riphah International University

    Investigators

    • Principal Investigator: saba Rafique, ppdpt, Riphah International University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Riphah International University
    ClinicalTrials.gov Identifier:
    NCT05356689
    Other Study ID Numbers:
    • REC/Lhr/22/0126 Hassan
    First Posted:
    May 2, 2022
    Last Update Posted:
    May 2, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    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 Riphah International University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 2, 2022