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

NCT ID: NCT05356689

Last Updated: 2022-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-03-31

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

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

Conditions

Lumbar Radiculopathy; Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

mechanical traction

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

mechanical traction

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

core strengthening

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

saba Rafique, ppdpt

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Life Line Hospital

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

imran Amjad, phd

Role: CONTACT

imran.amjad@riphah.edu.pk

03324390125

Facility Contacts

saba Rafique

Role: primary

saba.rafique@riphah.edu

03034045433

References

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

Reference Type: BACKGROUND

PMID: 17445735 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22543563 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31788391 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31456418 (View on PubMed)

Other Identifiers

REC/Lhr/22/0126 Hassan

Identifier Type: -

Identifier Source: org_study_id