IRCT | Effects of Complex Rehabilitation Program on Reducing Pain and Disability in Patients with Lumbar Disc Protrusion. Is Early Intervention the Best Recommendation?

Protocol summary

Study aim: The main objective of this study was to determine the complex physiotherapy program effectiveness versus electrotherapy-only intervention on pain and disability reduction, and increased muscle strength and mobility in patients with lumbar disc protrusions. The second objective was to investigate if there is a correlation between early rehabilitation intervention and pain and disability.
Design: A non-randomized, controlled, parallel groups on 60 patients, single-blind (outcome assessment)
Settings and conduct: Ceres Hotel Treatment Centre from Băile 1 Mai, Romania. Single blinded (the evaluator has no information about the patients or about the study protocol)
Participants/Inclusion and exclusion criteria: Inclusion criteria: 25-80 years of age, low back pain for more than three months, an MRI confirmed diagnosis of lumbar disc protrusion (without dural compression), ability to perform a physical therapy program. Exclusion criteria: indication for acute surgery, previous surgery on the same lumbar spinal level, sciatica, presence of severe spinal pathology (spinal tumor, spinal fracture, spinal stenosis or radiculopathy, fibromyalgia, inflammatory and infectious spinal diseases). Chronic pain relief drug users, refusal to participate in the research, any sort of neoplasm, severe comorbidity, mental illness.
Intervention groups: The control group (Gr A) received only a classical electrotherapy program. In addition, the patients in the experimental group (Gr B) received a complex individualized physical exercise therapy program associated with hydrotherapy and electrotherapy.
Main outcome variables: Spinal mobility, pain, muscle strength, Oswestry Disability Index (ODI)

General information

Reason for update
Acronym: CRP
IRCT registration information: IRCT registration number: IRCT20200422047172N2

Registration date: 2022-03-21, 1401/01/01

Registration timing: retrospective

Last update: 2022-03-21, 1401/01/01

Update count: 0
Registration date: 2022-03-21, 1401/01/01

Registrant information: Name

Elena Sirbu

Name of organization / entity

West University of Timisoara,

Country

Romania

Phone

+40 256 498 176

Email address

elena.sirbu@e-uvt.ro

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2021-07-21, 1400/04/30
Expected recruitment end date: 2022-01-31, 1400/11/11
Actual recruitment start date: 2021-07-21, 1400/04/30
Actual recruitment end date: 2022-01-21, 1400/11/01
Trial completion date: 2022-01-31, 1400/11/11

Scientific title: Effects of Complex Rehabilitation Program on Reducing Pain and Disability in Patients with Lumbar Disc Protrusion. Is Early Intervention the Best Recommendation?

Public title: Effects of Complex Rehabilitation Program on Reducing Pain and Disability in Patients with Lumbar Disc Protrusion.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

25-80 years of age low back pain for more than three months MRI confirmed diagnosis of lumbar disc protrusion (without dural compression) ability to perform a physical therapy program

Exclusion criteria:

indication for acute surgery previous surgery on the same lumbar spinal level sciatica presence of severe spinal pathology (spinal tumour, spinal fracture, spinal stenosis or radiculopathy, fibromyalgia, inflammatory and infectious spinal diseases) chronic use of pain killer drugs refusal to participate in the research neoplasms of any sort, severe comorbidities mental illness refusal to participate in the research
Age: From 26 years old to 76 years old
Gender: Both

Phase

N/A

Groups that have been masked

Investigator

Sample size

Target sample size: 60

Actual sample size reached: 60

Randomization (investigator's opinion)

Not randomized

Randomization description

Blinding (investigator's opinion)

Single blinded

Blinding description

All assessments were made before intervention and 6 months later by the same physiotherapist, who was blinded to the treatment groups.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Local Ethics Committee, University of Oradea

Street address

Str. Universităţii nr. 1

City

Oradea

Postal code

410087
Approval date: 2021-07-14, 1400/04/23
Ethics committee reference number: 1947/14.07.2021

Health conditions studied

1

Description of health condition studied: Low back pain
ICD-10 code: M51.86
ICD-10 code description: Other intervertebral disc disorders, lumbar region

Primary outcomes

1

Description: pain
Timepoint: before intervention and 6 months after intervention
Method of measurement: Short Form McGill Pain Questionnaire (SF-MPQ) and visual analogue scale (VAS)

2

Description: disability
Timepoint: before intervention and 6 months after intervention
Method of measurement: Oswestry Disability Index (ODI)

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group 1/Experimental group: 30 patients received a complex individualized physical therapy (PT) program associated with hydro-therapy(HT) and electrotherapy (ET). Hydrotherapy was performed in a therapeutic pool for 30 min a day, 5-days a week for a total duration of 10 days. The PT program was given to all patients for 45 min a day, 5-days a week for a total duration of 10 days. After completing the exercise PT program, electrotherapy ET was applied to each patient. The electrotherapy ET procedures consisted of: 1) Transcutaneous electrical nerve stimulation (TENS) in conventional mode, symmetric biphasic, 90 Hz, for 15 min; 2) Interferential current (IFC) in quadripolar mode, at 100 Hz frequency, for 10 min; 3) Magnetic field therapy in continuous form (sedative effect), for 15 min. TENS and IFC were performed using the Chattanooga Intelect Neo combined de-vice. The magnetic field was delivered through a Physiomed MAG-Expert device with a field strength of 1–100 Gauss (adjustable in steps of one Gauss) and a frequency range from 1 to 100 Hz, with two completely independent channels and a treatment timer.
Category: Rehabilitation

2

Description: Intervention group/Control group: 30 patients received classical electrotherapy program (ET) for 10 days. The electrotherapy ET protocol was the same as for the experimental group (TENS, IFC, Magnetic field therapy)
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Ceres Hotel Treatment Centre

Full name of responsible person

Florin Marcu

Street address

Haieu Street

City

Baths 1 Mai

Postal code

417501

Phone

+40 745 883 047

Email

mfmihai27@yahoo.com

1

Sponsor: Name of organization / entity

Department of Physical Education, Sport and Physiotherapy, University of Oradea

Full name of responsible person

Emilian Tarcău

Street address

No. 1, Universității Street

City

Oradea

Postal code

410087

Phone

+40 770 104 471

Email

emilian.tarcau@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: No
Title of funding source: Department of Physical Education, Sport and Physiotherapy, University of Oradea
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

West University of Timisoara

Full name of responsible person

Elena Sirbu

Position

Associate professor

Latest degree

Ph.D.

Other areas of specialty/work

Rheumatology

Street address

No 4, Parvan Street

City

Timisoara

Province

Timis

Postal code

300233

Phone

+40 744 238 960

Email

elena.sirbu@e-uvt.ro

Person responsible for scientific inquiries

Contact: Name of organization / entity

West University of Timisoara

Full name of responsible person

Elena Sirbu

Position

Associate professor

Latest degree

Ph.D.

Other areas of specialty/work

Rheumatology

Street address

No. 4, V Parvan

City

Timisoara

Province

Timis

Postal code

300233

Phone

+40 744 238 960

Email

elena.sirbu@e-uvt.ro

Person responsible for updating data

Contact: Name of organization / entity

West University of Timisoara

Full name of responsible person

Elena Sirbu

Position

Associate professor

Latest degree

Ph.D.

Other areas of specialty/work

Rheumatology

Street address

No. 4, V Parvan

City

Timisoara

Province

Timis

Postal code

300233

Phone

+40 744 238 960

Email

elena.sirbu@yahoo.co.uk

Sharing plan

Deidentified Individual Participant Data Set (IPD): No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD: There is no further information
Study Protocol: No - There is not a plan to make this available
Statistical Analysis Plan: No - There is not a plan to make this available
Informed Consent Form: No - There is not a plan to make this available
Clinical Study Report: Not applicable
Analytic Code: No - There is not a plan to make this available
Data Dictionary: No - There is not a plan to make this available

Effects of Complex Rehabilitation Program on Reducing Pain and Disability in Patients with Lumbar Disc Protrusion. Is Early Intervention the Best Recommendation?