NCT04653870

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
Last Updated

December 4, 2020

Status Verified

November 1, 2020

Enrollment Period

7 months

First QC Date

November 28, 2020

Last Update Submit

November 28, 2020

Conditions

Keywords

HerniationCyriax manipulationdecompressionbulgeprotrudedextruded

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

cyriax manipulation

EXPERIMENTAL

cyriax manipulation have three types of classes, rotation, extension and anti-deviation, which is further divided into subclasses. On the inferior level of lumber spine L4-L5 and L5-S1rotation intervention of manipulation are capable of having striking effects of decreasing herniation. First of all we have to perform the simple 'stretch' on lumber spine, which is being the little rotation pressure applied on the body. The patient position of the body is in side lying with the effected side upward so that the outside part of the joint are separated easily on the involved side. After that, whenever it is essential by making use of femur as a rigid bar or support, this maneuver is go along with powerful rotation technique.

Other: cyriax manipulation lumber

lumber decompresion

EXPERIMENTAL

Spinal decompression therapy has been developed a treatment without surgery for the prolapsed disc and deteriorative spinal disc disease one of the considerable reason for low back pain. This noninvasive interventional treatment for herniated disc and deteriorative disc diseases operated on the principle of remarkably decreasing the pressure on the disc between vertebras.

Other: lumber decompression

Interventions

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.

cyriax manipulation

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. .

lumber decompresion

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients having Lumber disc prolapse of L1-L5 and S1 (both gender)
  • Patients having MRI reports of protruded disc

You may not qualify if:

  • Inflammatory condition( systemic inflammatory disease of spine)
  • Spinal diseases (other than Musculoskeletal)
  • Severe radiculopathies (bilateral)
  • Operated patients (spine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Max health hospital and rehab center G8 islamabad

Islamabad, Punjab Province, 44080, Pakistan

Location

Related Publications (5)

  • Kocak FA, Tunc H, Tomruk Sutbeyaz S, Akkus S, Koseoglu 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.

    PMID: 31453485BACKGROUND
  • 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. doi: 10.1136/bmj.304.6827.601.

    PMID: 1532760BACKGROUND
  • 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.

    PMID: 24636109BACKGROUND
  • 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.

    PMID: 27034106BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc DisplacementHernia

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Affan Iqbal, Phd*

    Riphah International University

    PRINCIPAL INVESTIGATOR

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

November 28, 2020

First Posted

December 4, 2020

Study Start

February 10, 2020

Primary Completion

August 25, 2020

Study Completion

September 8, 2020

Last Updated

December 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations