Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04653870
Other study ID # REC/00681 Salma Bibi
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 10, 2020
Est. completion date September 8, 2020

Study information

Verified date November 2020
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, compare the effects of Cyriax manipulation and Decompression in patient with lumber disc prolapseThis research will provide an important addition to the evidence based treatment intervention in physical therapy in the field of manipulation as there is no such research work have been done on comparative study of cyriax manipulation and decompression in lumber disc protrusion.


Description:

According to an estimate, 70 to 80% of the adult population will experience a clinically relevant episode of LBP at some time in their lives. Within the vast differential of LBP, the most common source is intervertebral degeneration leading to degenerative disc disease and LDH. The efficacy of manipulative physical therapy, physical therapy intervention and therapy by general practitioner (GP) for persistent general LBP and neck pain was investigated on 256 patients how didn't received any of the above therapy in last two years were contained in this study. Physical therapy included workout exercises, massage, and physical therapy (related to hot pack, different pain modalities like therapeutic ultrasound, shortwave diathermy, and electrotherapy). Manual therapy includes manual reduction by manipulation and mobilization of the back. Interventions received by GP is medicine related (different types of pain killer and muscles relaxant), guidance about the posture, home plan exercises and different healthy activities and proper rest. Placebo intervention included adjustable shortwave diathermy session for (10 minutes), and adjusted therapeutic ultrasound session for (10 minutes). Recovery rate in the leading complaint was increased with the group receiving manual therapy intervention (4.5) as compare to physical therapy (3.8), after a detailed one year of continuous therapy. There is a great progression seen in physical work by manual therapy. Moreover, manipulation is get going improved gradually, as compare to physiotherapy following in period of 12 months. The first meta-analysis estimated the efficacy of SMT for LBP due to LDH with other therapies come to the result that SMT was equally effective when compare to other traditional therapies. However a past systematic review was come to the conclusion that SMT was secure and effective in relation to its costs for managing SLDD like LDH, that conclusion was quoted to promote by a very few publications. One of the present research studies after one year of continuation showed decrease in pain and increase in recreational activities to a long period of time, an additional research work in 2016 described, a remarkable progression in sciatica after 30 days, in patients with lumber discs extrusion and sequestration, as a result of HVLA thrust. In spite of the factor that there is only average numbers of documentation in the written work which promoted the utilization of SMT to manage LDH, it is extensively applied by therapist. the comparison of cyriax manipulation and decompresion is an important adding to the researches in evidence based practices. there is no such work done before on comparison of both intervention.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 8, 2020
Est. primary completion date August 25, 2020
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria: - Patients having Lumber disc prolapse of L1-L5 and S1 (both gender) - Patients having MRI reports of protruded disc Exclusion Criteria: - Inflammatory condition( systemic inflammatory disease of spine) - Spinal diseases (other than Musculoskeletal) - Severe radiculopathies (bilateral) - Operated patients (spine)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
cyriax manipulation lumber
In group A patients were treated with conservative therapy (hot pack, Kaltenborn soft tissue techniques and home plan) and Cyriax manipulation. Exercises (Guided low back exercises, 3-5times/day). Ankle pumping (5-10 repetition with 15-20 second hold), Quads Isometric (5-10 repetition with 15-20 second hold), Hams & Calf stretching (5-10 repetition with 15-20 second hold), Bridging (5-10 repetition with 15-20 second hold), Prone Back extension (10 repetition) Precaution Prevent yourself from sitting low on ground, Sitting with support will be directed and be careful during driving and ascending stairs. Cyriax Manipulation: 2-3 repetitions/session, 2 session/week Lumbar spinal manipulation Rotation Techniques Lumbar spinal manipulation Extension Techniques Lumbar spinal manipulation Antideviation Techniques total of 4 session were given. 2 session/week.
lumber decompression
Group B: In group B patients were treated with conservative therapy (hot pack, Kaltenborn soft tissue techniques and home plan) and Decompression Session. Conservative therapy: Same as Group A Lumbar spine decompression: 30 Minutes Session (generalized time for every one) . On the account of MRI description level is recommended and acknowledged by MRI the level of disc protrusion, decompression is operated. Patient is lying on table facing upward. For locking of the patient's body it was secured by pelvis and thoracic straps. One part of the decompression table is immobile other is movable. Bottom extreme part of the table is mobile. Estimation of weight of patient is first thing to do. We calculated it by division of whole weight by 5 and that 5th segment of weight was utilized as an interventional pound for decompression. .

Locations

Country Name City State
Pakistan Max health hospital and rehab center G8 islamabad Islamabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

Ehrler M, Peterson C, Leemann S, Schmid C, Anklin B, Humphreys BK. Symptomatic, MRI Confirmed, Lumbar Disc Herniations: A Comparison of Outcomes Depending on the Type and Anatomical Axial Location of the Hernia in Patients Treated With High-Velocity, Low-Amplitude Spinal Manipulation. J Manipulative Physiol Ther. 2016 Mar-Apr;39(3):192-9. doi: 10.1016/j.jmpt.2016.02.013. Epub 2016 Mar 28. — View Citation

Koçak FA, Tunç H, Tomruk Sütbeyaz S, Akkus S, Köseoglu BF, Yilmaz E. Comparison of the short-term effects of the conventional motorized traction with non-surgical spinal decompression performed with a DRX9000 device on pain, functionality, depression, and quality of life in patients with low back pain associated with lumbar disc herniation: A single-blind randomized-controlled trial. Turk J Phys Med Rehabil. 2017 Feb 16;64(1):17-27. doi: 10.5606/tftrd.2017.154. eCollection 2018 Mar. — View Citation

Koes BW, Bouter LM, van Mameren H, Essers AH, Verstegen GM, Hofhuizen DM, Houben JP, Knipschild PG. Randomised clinical trial of manipulative therapy and physiotherapy for persistent back and neck complaints: results of one year follow up. BMJ. 1992 Mar 7;304(6827):601-5. — View Citation

Leemann S, Peterson CK, Schmid C, Anklin B, Humphreys BK. Outcomes of acute and chronic patients with magnetic resonance imaging-confirmed symptomatic lumbar disc herniations receiving high-velocity, low-amplitude, spinal manipulative therapy: a prospective observational cohort study with one-year follow-up. J Manipulative Physiol Ther. 2014 Mar-Apr;37(3):155-63. doi: 10.1016/j.jmpt.2013.12.011. Epub 2014 Mar 11. — View Citation

Oh H-J, Jeon C-B, Jeong M-G, Choi S-J. The effects of spinal decompression therapy on pain and disability in patients with chronic low back pain. The Journal of Korean Physical Therapy. 2017;29(6):299-302.

Outcome

Type Measure Description Time frame Safety issue
Primary Inclinometer Inclinometer: Dual inclinometer is used to measure dynamic ROM of lumber spine. For measuring the ROM of flexion, extension and side bending to both sides, place one inclinometer on T12 and the other on S1. Ask the patient to bend forward for flexion, bend backward for extension and sideways for side bending. Note both the readings and subtract the lower one from the above. 2nd week
Primary goniometer Goniometer is used to measure SLR range before and after the treatment For the patients to perform SLR, participants lay supine on a table and are asked to actively raise their leg from the table while keeping their knee straight. Reproduction of the patient's characteristic pain or demonstration of weakness can lead to decreased range of SLR. Symptom production between the ranges of 30 degrees to 60 degrees is an indication of disc pathology. 2nd week
Primary Numeric pain rating scale Numeric pain rating scale: Pain is measured by NPRS before Treatment and after treatment. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the pain where zero is no pain and 10 is maximum pain (for back and leg) 2nd week
Primary Oswestry disability index (ODI) Oswestry disability index (ODI): Disability is measured by ODI before Treatment and after treatment. It 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. it consist of 10, five parts sections. at the end,s core is calculated by dividing the obtained score by total 50, and multiplied by 100. as the sexual section is missing due to ethical reason so total score is 45 instead of 50. 2nd week
See also
  Status Clinical Trial Phase
Recruiting NCT05277818 - Post-marketing Clinical Follow-up of the Medical Device DIVA®
Recruiting NCT05467072 - PMCFU of an Annular Closure System
Withdrawn NCT03252691 - Incidence of Large Annular Defects in Primary Lumbar Discectomy Patients
Withdrawn NCT01622413 - Trial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy N/A
Completed NCT04329598 - Effects of Whole-Body Electromyostimulation Application in Individuals With Lumbar Disc Hernia N/A
Completed NCT04061759 - Physiotherapy in Lumbar Disc Pathologies N/A
Completed NCT04073095 - Erector Spinae Plane Block and Modified-Thoracolumbar Interfascial Plane Block Following Lumbar Spinal Surgery N/A
Active, not recruiting NCT06140862 - Ankle Spine Syndrome "RAFFET Syndrome II N/A
Active, not recruiting NCT05613179 - Brain Effect Mechanism of Lever Positioning Manipulation on LDH Analgesia Based on Multimodal MRI N/A
Completed NCT04587401 - The Effects of Anesthesia on Cerebral Perfusion in Patients With High Blood Pressure N/A
Recruiting NCT05663437 - Effectiveness of Core Stabilization Exercises With and Without Neural Mobilization Technique in Female Patients With Lumbar Radiculopathy Due to Disc Herniation - an RCT Study N/A
Recruiting NCT06076408 - Effects of SNAGS With and Without Pilates in Lumbar Disc Bulge Patients N/A
Completed NCT05999253 - Comparison of the Efficacy of Thoracolumbar Interfascial Plane Block and Erector Spina Plane Block in Lumbar Discectomy
Recruiting NCT03002207 - Repairing the Defect of Intervertebral Disc With Autologous BMSC and Gelatin Sponge After Microendoscopic Discectomy for Lumbar Disc Herniation N/A
Not yet recruiting NCT05487690 - Application of 3D Printing Guide Plate in Spinal Minimally Invasive and Interventional Surgeries N/A
Completed NCT05003726 - Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation N/A
Completed NCT05556538 - The Effect of Subcutaneous Fat Tissue Thickness on Lumbar Transforaminal Epidural Steroid Injection Treatment Success
Not yet recruiting NCT04083703 - Evaluation of Interbody Cage Insertion in Treatment of Lumbar Disc Prolapse N/A
Completed NCT03832036 - The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients With Lumbar Disc Herniation N/A
Not yet recruiting NCT05584774 - Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty N/A