Effects of Decompression in Patient With Acute vs Chronic Lumbar Radiculopathy

NCT ID: NCT04674917

Last Updated: 2021-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-30

Study Completion Date

2021-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study will be done to evaluate the effectiveness of Lumbar Spinal Decompression in patients with acute vs chronic lumbar radiculopathy. Study design will be Randomized control trial and sample size will be 30. Duration of study was of 6 month, convenient sampling was done. Data will be collected from DHQ Daska were randomly allocated in three groups via lottery method, baseline assessment was done. Patients of both gender (male and female) from 18 to 50 years with lumbar radiculopathy diagnosed through X-ray and physical examination will be included. Patients with systemic soft tissue and bony diseases will be excluded. Intervention duration of 4 weeks, 3 sessions in a week. Decompression of lumbar spine will be given once in a week. Whole procedure of treatment program will given to patients and written informed consent will be taken. Basic tools will be Visual analog scale (VAS), SLR, ODI, Inclinometer. Data was analyzed by using SPSS version 21

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Low back pain (LBP) is one of the most common musculoskeletal conditions treated by physical therapists. Although lumbar traction is frequently used by physical therapists in the treatment of patients with LBP. We will use Manual Lumber Spinal Traction on patients with acute vs chronic lumber radiculopathy. The current study will determine the effect of decompression in relieving pain, increase range of motion and improving function in patients of acute and chronic lumbar radiculopathy. Lumbar traction (LT) is routinely used on its own or in conjunction with other treatments for the management of lumbar sciatica. We will use Manual lumbar traction along with hot pack, tens, mobilization and exercise therapy. Intervention duration of 4 weeks, 3 sessions in a week. Decompression of lumbar spine will be given once in a week.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lumbar Radiculopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

Decompression + Hot pack, TENS, Mobilization, Exercise Therapy

Group Type EXPERIMENTAL

Decompression + Hot pack, TENS, Mobilization, Exercise Therapy

Intervention Type OTHER

Group A which includes the acute group to study the effects of decompression we will apply the three main basic treatments along with decompression which is our main goal..

The basic treatments are

1. Hot Pack
2. TENSE
3. Mobilization ( on lumbar L1 toL5 ) Our first modality which is hot pack will be given to the patients for a duration of 15 minutes The next modality TENSE will be given for 10 minutes

The third treatment which is mobilization will be given 1 time on each joint of lumbar spine All these treatments must given in combination with the decompression.

Group B

Decompression + Hot pack, TENS, Mobilization, Exercise Therapy

Group Type EXPERIMENTAL

Decompression + Hot pack , TENS , Mobilization , Exercise Therapy

Intervention Type OTHER

Group B which includes the chronic group to study the effects of decompression we will apply the three main basic treatments along with decompression which is our main goal..

The basic treatments are

1. Hot Pack
2. TENSE
3. Mobilization ( on lumbar L1 toL5 )

Our first modality which is hot pack will be given to the patients for a duration of 15 minutes The next modality TENSE will be given for 10 minutes

The third treatment which is mobilization will be given 1 time on each joint of lumbar spine All these treatments must given in combination with the decompression.

Group C

Hot pack , TENS, Mobilization, Exercise therapy

Group Type OTHER

Hot pack , TENS, Mobilization, Exercise therapy

Intervention Type OTHER

Group C which is our control group to compare it with the groups A and B to study the effects of decompression on lumbar radiculopathy The basic treatments are

1. Hot Pack
2. TENSE
3. Mobilization ( on lumbar L1 toL5 )

Our first modality which is hot pack will be given to the patients for a duration of 15 minutes The next modality TENSE will be given for 10 minutes

The third treatment which is mobilization will be given 1 time on each joint of lumbar spine It is kept in mind that in this group we will not apply the decompression along with the above treatments.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Decompression + Hot pack, TENS, Mobilization, Exercise Therapy

Group A which includes the acute group to study the effects of decompression we will apply the three main basic treatments along with decompression which is our main goal..

The basic treatments are

1. Hot Pack
2. TENSE
3. Mobilization ( on lumbar L1 toL5 ) Our first modality which is hot pack will be given to the patients for a duration of 15 minutes The next modality TENSE will be given for 10 minutes

The third treatment which is mobilization will be given 1 time on each joint of lumbar spine All these treatments must given in combination with the decompression.

Intervention Type OTHER

Decompression + Hot pack , TENS , Mobilization , Exercise Therapy

Group B which includes the chronic group to study the effects of decompression we will apply the three main basic treatments along with decompression which is our main goal..

The basic treatments are

1. Hot Pack
2. TENSE
3. Mobilization ( on lumbar L1 toL5 )

Our first modality which is hot pack will be given to the patients for a duration of 15 minutes The next modality TENSE will be given for 10 minutes

The third treatment which is mobilization will be given 1 time on each joint of lumbar spine All these treatments must given in combination with the decompression.

Intervention Type OTHER

Hot pack , TENS, Mobilization, Exercise therapy

Group C which is our control group to compare it with the groups A and B to study the effects of decompression on lumbar radiculopathy The basic treatments are

1. Hot Pack
2. TENSE
3. Mobilization ( on lumbar L1 toL5 )

Our first modality which is hot pack will be given to the patients for a duration of 15 minutes The next modality TENSE will be given for 10 minutes

The third treatment which is mobilization will be given 1 time on each joint of lumbar spine It is kept in mind that in this group we will not apply the decompression along with the above treatments.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* history of radicular pain with straight leg raise (SLR).
* Patients in the acute phase of (up to 6 weeks) included in group A
* Patients in chronic phase of (more than 6 weeks) included in group B

Exclusion Criteria

* Any systemic soft tissue and bony disease.
* Patient with spinal tuberculosis, spinal fractures, pregnancy, cancer.
* Any recent surgery.
* Patient with any cervical or thoracic problem.
* Patients with any other serious pathology/red flags
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Syed Shakil Ur Rehman

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

DHQ hospital

Daska Kalan, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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)

Swanson BT, Riley SP, Cote MP, Leger RR, Moss IL, Carlos J Jr. Manual unloading of the lumbar spine: can it identify immediate responders to mechanical traction in a low back pain population? A study of reliability and criterion referenced predictive validity. J Man Manip Ther. 2016 May;24(2):53-61. doi: 10.1179/2042618614Y.0000000072.

Reference Type BACKGROUND
PMID: 27559274 (View on PubMed)

Rubinic DM, Koo V, Dudley J, Owens SC. Changes in Spinal Height After Manual Axial Traction or Side Lying: A Clinical Measure of Intervertebral Disc Hydration Using Stadiometry. J Manipulative Physiol Ther. 2019 Mar-Apr;42(3):187-194. doi: 10.1016/j.jmpt.2019.03.005. Epub 2019 May 9.

Reference Type BACKGROUND
PMID: 31078315 (View on PubMed)

Asiri F, Tedla JS, D Alshahrani MS, Ahmed I, Reddy RS, Gular K. Effects of patient-specific three-dimensional lumbar traction on pain and functional disability in patients with lumbar intervertebral disc prolapse. Niger J Clin Pract. 2020 Apr;23(4):498-502. doi: 10.4103/njcp.njcp_285_19.

Reference Type BACKGROUND
PMID: 32246656 (View on PubMed)

Mo Z, Li D, Zhang R, Chang M, Yang B, Tang S. Comparisons of the Effectiveness and Safety of Tuina, Acupuncture, Traction, and Chinese Herbs for Lumbar Disc Herniation: A Systematic Review and Network Meta-Analysis. Evid Based Complement Alternat Med. 2019 Mar 20;2019:6821310. doi: 10.1155/2019/6821310. eCollection 2019.

Reference Type BACKGROUND
PMID: 31015852 (View on PubMed)

Mitchell UH, Beattie PF, Bowden J, Larson R, Wang H. Age-related differences in the response of the L5-S1 intervertebral disc to spinal traction. Musculoskelet Sci Pract. 2017 Oct;31:1-8. doi: 10.1016/j.msksp.2017.06.004. Epub 2017 Jun 9.

Reference Type BACKGROUND
PMID: 28624722 (View on PubMed)

Isner-Horobeti ME, Dufour SP, Schaeffer M, Sauleau E, Vautravers P, Lecocq J, Dupeyron A. High-Force Versus Low-Force Lumbar Traction in Acute Lumbar Sciatica Due to Disc Herniation: A Preliminary Randomized Trial. J Manipulative Physiol Ther. 2016 Nov-Dec;39(9):645-654. doi: 10.1016/j.jmpt.2016.09.006. Epub 2016 Nov 9.

Reference Type BACKGROUND
PMID: 27838140 (View on PubMed)

Tadano S, Tanabe H, Arai S, Fujino K, Doi T, Akai M. Lumbar mechanical traction: a biomechanical assessment of change at the lumbar spine. BMC Musculoskelet Disord. 2019 Apr 9;20(1):155. doi: 10.1186/s12891-019-2545-9.

Reference Type BACKGROUND
PMID: 30961554 (View on PubMed)

Creighton D, Schweiger A, Cubr S. Immediate Effects of Side Lying Manual Lumbar Traction in Patients with Painful Active Lumbar Motion. Journal of International Academy of Physical Therapy Research. 2017;8(1):1071-6.

Reference Type BACKGROUND

Oh H, Choi S, Lee S, Choi J, Lee K. The impact of manual spinal traction therapy on the pain and Oswestry disability index of patients with chronic back pain. J Phys Ther Sci. 2018 Dec;30(12):1455-1457. doi: 10.1589/jpts.30.1455. Epub 2018 Nov 21.

Reference Type BACKGROUND
PMID: 30568333 (View on PubMed)

Kisner C, Colby LA, Borstad J. Therapeutic exercise: foundations and techniques: Fa Davis; 2017.

Reference Type BACKGROUND

Thackeray A, Fritz JM, Childs JD, Brennan GP. The Effectiveness of Mechanical Traction Among Subgroups of Patients With Low Back Pain and Leg Pain: A Randomized Trial. J Orthop Sports Phys Ther. 2016 Mar;46(3):144-54. doi: 10.2519/jospt.2016.6238. Epub 2016 Jan 26.

Reference Type BACKGROUND
PMID: 26813755 (View on PubMed)

Szulc P, Wendt M, Waszak M, Tomczak M, Cieslik K, Trzaska T. Impact of McKenzie Method Therapy Enriched by Muscular Energy Techniques on Subjective and Objective Parameters Related to Spine Function in Patients with Chronic Low Back Pain. Med Sci Monit. 2015 Sep 29;21:2918-32. doi: 10.12659/MSM.894261.

Reference Type BACKGROUND
PMID: 26418868 (View on PubMed)

Lo WLA, Lei D, Leng Y, Huang H, Wang B, Yu Q, Li L. Impact of nonsurgical spinal decompression on paraspinal muscle morphology and mechanical properties in young adults with low back pain. J Int Med Res. 2020 Jul;48(7):300060520919232. doi: 10.1177/0300060520919232.

Reference Type BACKGROUND
PMID: 32723102 (View on PubMed)

Hallur SS, Brismee JM, Sizer PS, Dierick F, Dewan BM, Thiry P, Sobczak S. Three-Dimensional Spinal Position With and Without Manual Distraction Load Increases Spinal Height. J Manipulative Physiol Ther. 2020 May;43(4):267-275. doi: 10.1016/j.jmpt.2019.04.007. Epub 2020 Jul 21.

Reference Type BACKGROUND
PMID: 32709513 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/LHR/20/1051 Mariam Waseem

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.