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

NCT05356689 | Unknown

• 1 other identifier: REC/Lhr/22/0126 Hassan
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Conditions

Lumbar Radiculopathy; Radiculopathy

Keywords

radiculopathy; lumber

Outcome Measures

Primary Outcomes (2)

• Numerical Pain Rating Scale (NPRS)

  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)

  10 months

• Oswestry Disability Index (ODI)

  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

  10 months

Study Arms (2)

traditional physiotherapy

EXPERIMENTAL

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

3- 2dimensional lumbar traction

EXPERIMENTAL

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

Interventions

mechanical traction OTHER

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.

Also known as: core strengthening

3- 2dimensional lumbar traction; traditional physiotherapy

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Life Line Hospital

Lahore, Punjab Province, 38000, Pakistan

RECRUITING

Related Publications (4)

• Tarulli AW, Raynor EM. Lumbosacral radiculopathy. Neurol Clin. 2007 May;25(2):387-405. doi: 10.1016/j.ncl.2007.01.008.

  PMID: 17445735 BACKGROUND

• Schoenfeld AJ, Laughlin M, Bader JO, Bono CM. Characterization of the incidence and risk factors for the development of lumbar radiculopathy. J Spinal Disord Tech. 2012 May;25(3):163-7. doi: 10.1097/BSD.0b013e3182146e55.

  PMID: 22543563 BACKGROUND

• Berry JA, Elia C, Saini HS, Miulli DE. A Review of Lumbar Radiculopathy, Diagnosis, and Treatment. Cureus. 2019 Oct 17;11(10):e5934. doi: 10.7759/cureus.5934.

  PMID: 31788391 BACKGROUND

• Cheng YH, Hsu CY, Lin YN. The effect of mechanical traction on low back pain in patients with herniated intervertebral disks: a systemic review and meta-analysis. Clin Rehabil. 2020 Jan;34(1):13-22. doi: 10.1177/0269215519872528. Epub 2019 Aug 28.

  PMID: 31456418 BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• saba Rafique, ppdpt

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

imran Amjad, phd

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 2, 2022
• Study Start: March 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 31, 2023
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)