Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620001274965
Ethics application status
Approved
Date submitted
23/04/2020
Date registered
25/11/2020
Date last updated
25/11/2020
Date data sharing statement initially provided
25/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of spinal manipulations versus flexion-distraction technique in patients with lumbar disc hernia or protrusion.
Scientific title
Effects of high velocity spinal manipulation versus flexion-distraction technique in patients with lumbar disc hernia or protrusion. A randomized single blind controlled trial
Secondary ID [1] 301029 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low back pain 317080 0
lumbar disc hernia 317081 0
Condition category
Condition code
Physical Medicine / Rehabilitation 315248 315248 0 0
Physiotherapy
Musculoskeletal 317689 317689 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be informed in a previous meet about their rights to withdraw the study at any moment and the treatments treatments that would be applied, without outstanding one over at the other. Then they will be randomly allocated either in a spinal manipulation group or a flexion distraction treatment group.

Both groups will receive the treatments in a facility. An expert physiotherapist and chiropractor with more than 10 years of experience with these techniques will apply the treatments. The base of treatment will consist on ischemic compression on the four trigger points of quadratus lumborum muscle and the two trigger points of psoas-iliaque for 90 seconds. After this, participants will receive flexion-distraction treatment or spinal manipulation according to their group:

-The Flexion-distraction treatment will consist on placing the participant in prone position on a Flexion-distraction table and apply 10x10 flexion-distraction movements with 1 minute of resting among each serie of 10 repetitions.

-The spinal manipulation treatment will consist on a lumbar-roll manipulative technique on L3 vertebral level.

Both interventions will be applied twice a week (with a difference of 72 hours between them) during two weeks (four treatment sessions in total) in the same time (morning or afternoon). Each session will take 10 minutes long. An attendance checklist will be used to assess adherence to intervention
Intervention code [1] 317338 0
Rehabilitation
Comparator / control treatment
The group receiving spinal manipulation in addition to the base treatment will be considered the control/comparator group
Control group
Active

Outcomes
Primary outcome [1] 323587 0
Lumbar function, with Oswestry questionnaire
Timepoint [1] 323587 0
Before the first session of treatment (baseline) and after the last session of treatment (2 weeks)
Primary outcome [2] 323588 0
Lumbar function with Schober test
Timepoint [2] 323588 0
Before the first session of treatment (baseline) and after the last session of treatment (2 weeks)
Primary outcome [3] 323589 0
Pain measured with Numerical Pain Rating Scale
Timepoint [3] 323589 0
Before the first session of treatment (baseline) and after the last session of treatment (2 weeks)
Secondary outcome [1] 382293 0
Lumbar function with Fingers to floor test
Timepoint [1] 382293 0
Before the first session of treatment (baseline) and after the last session of treatment (2 weeks)
Secondary outcome [2] 382294 0
Pressure pain threshold measured with digital algometer
Timepoint [2] 382294 0
Before the first session of treatment (baseline) and after the last session of treatment (2 weeks)

Eligibility
Key inclusion criteria
-Participants with low back pain of over 3 months of evolution
-Participants with almost 3 points of pain measured with numerical pain rating scale
-Participants with lumbar disc hernia o protrusion diagnosed by magnetic resonance imaging (MRI)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Participants under pharmacological treatment for pain
-Participants under any other treatment for low back pain in the last month (therapeutic exercise, physiotherapy, osteopath, chiropractor, painkillers, acupuncture...)
-Participants who had undergone any hip or spine surgery
-Participants with neurodegenerative diseases
-Participants with cancer
-Participants with fibromyalgia diagnosis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The researcher in charge of allocation will be different from the one evaluating participants and the one applying the treatments.

Sealed opaque envelopes will be used to inform participants about their allocation (treatment groups will be named as "red", "blue" and "green" in order to avoid identification of the treatments by participant).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated using MedCalc Statistical Software version
19.2.1 (MedCalc Software Ltd, Ostend, Belgium; https://www.medcalc.org;
2020). Making as reference data provide for Carrasco et al (2019) about
clinical success (improvement at least 50% in Visual Analogue Scale), to
obtain differences in clinical success rate between two samples with a
alfa error of 95% and power of 99%, 34 patients are required by group,
making a minimal sample size of 68 patients included in the study.

Kolgomorov-Smirnov will be used to assure the normal distribution of the sample. T-Student will be used to check the baseline comparability of both groups. Mixed ANOVA will be used to determine between group differences. ETA squared will be used to measure size effect in the time-treatment interaction

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/01/2021
Actual
Date of last participant enrolment
Anticipated
8/02/2021
Actual
Date of last data collection
Anticipated
22/02/2021
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment outside Australia
Country [1] 22507 0
Spain
State/province [1] 22507 0
Jaen

Funding & Sponsors
Funding source category [1] 305473 0
Self funded/Unfunded
Name [1] 305473 0
Country [1] 305473 0
Primary sponsor type
University
Name
Alfonso Ibáñez in representation of University of Jaen
Address
University of Jaen
Campus las Lagunillas
23071 JAEN. SPAIN
Country
Spain
Secondary sponsor category [1] 305871 0
None
Name [1] 305871 0
Address [1] 305871 0
Country [1] 305871 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305789 0
Research Ethics Committee of the University of Jaén, Spain.
Ethics committee address [1] 305789 0
University of Jaen
Campus las Lagunillas
Building B3, office 212
23071 JAEN (SPAIN)
Ethics committee country [1] 305789 0
Spain
Date submitted for ethics approval [1] 305789 0
12/04/2018
Approval date [1] 305789 0
27/04/2018
Ethics approval number [1] 305789 0
ABR.18/2.TES

Summary
Brief summary
Objectives: To determine effects of Flexion-Distraction (FD) technique in comparison
with a spinal manipulation protocol on low- back pain participants with lumbar disc herniation or protrusion regarding pain, function and pain pressure threshold on trigger points of quadratus lumborum muscles.
Design and methods: a single-blind randomized controlled trial will be conducted. A sample of patients suffering from low back pain and diagnosed with lumbar disc herniation or protrusion by magnetic resonance imaging were randomly assigned to either a FD group or a spinal manipulation group. The outcomes measured include pain (numerical pain rating score), Pressure Pain Threshold (PPT) on trigger points (TrPs) of the quadratus lumborum, function of low back spine with the Oswestry Disability Index (ODI) and Schober’s test, and the Finger Floor Distance test (FFDT) to measure changes in low-back spine motion. An Analysis of Covariance (ANCOVA) was used to measure group effect.

This study will allow to use more specific non-surgical treatments for patients with lumbar disc herniation of protrusion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101602 0
Prof Alfonso Ibáñez
Address 101602 0
University of Jaen
Campus las Lagunillas
Building B3, office 212
23071; JAEN (Spain)
Country 101602 0
Spain
Phone 101602 0
+34953213519
Fax 101602 0
Email 101602 0
[email protected]
Contact person for public queries
Name 101603 0
Prof Alfonso Ibáñez
Address 101603 0
University of Jaen
Campus las Lagunillas
Building B3, office 212
23071; JAEN (Spain)
Country 101603 0
Spain
Phone 101603 0
+34953213519
Fax 101603 0
Email 101603 0
[email protected]
Contact person for scientific queries
Name 101604 0
Prof Alfonso Ibáñez
Address 101604 0
University of Jaen
Campus las Lagunillas
Building B3, office 212
23071; JAEN (Spain)
Country 101604 0
Spain
Phone 101604 0
+34953213519
Fax 101604 0
Email 101604 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Researchers are not allowed to share data from participants


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.