Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000485639
Ethics application status
Approved
Date submitted
15/04/2014
Date registered
9/05/2014
Date last updated
9/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Stretching diaphragm: efficiency in patients with chronic low back pain
Scientific title
Evaluating the effect of stretching diaphragm on expiratory peak flow, range of motion and pain levels in patients with chronic low back pain: experimental, randomized, double-blind trial.
Secondary ID [1] 284145 0
NONE
Universal Trial Number (UTN)
U1111-1153-7240
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 291230 0
Condition category
Condition code
Physical Medicine / Rehabilitation 291576 291576 0 0
Physiotherapy
Musculoskeletal 292138 292138 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The stretching diaphragm technique will be carried out. Patient lying supine with bent legs on a cushion. Standing at the patient's head, the therapist pushes from the lower ribs towards the head during inspiration and keeping during exhalation.The subject is asked to breathe in from the thorax. The process is repeated ten times in two minutes. It was undertaken on a single occasion only.
Intervention code [1] 288839 0
Rehabilitation
Intervention code [2] 289277 0
Treatment: Other
Comparator / control treatment
Lying supine with legs bent on a cushion, the patient is going to keep the position for two minutes, which is the estimated time required for the technique. The therapist was watching a cycle of ten abdominal breaths. The hand of the therapist on the patient's abdomen led the exercise.
Control group
Active

Outcomes
Primary outcome [1] 291646 0
To assess the effectiveness of the stretching diaphragm technique in patients diagnosed of chronic low back pain by comparing the results obtained in the expiratory peak flow with those obtained before the intervention.We used a spirometer.
Timepoint [1] 291646 0
Immediately after the intervention.
Primary outcome [2] 291647 0
To assess the effectiveness of the stretching diaphragm technique in patients diagnosed of chronic low back pain by comparing results obtained in the distance finger-floor technique with those obtained before the intervention. We used the fingertip-to-floor distance (FFD) test.
Timepoint [2] 291647 0
Immediately after the intervention
Secondary outcome [1] 307221 0
Low back pain is assessed using a Visual Analogue Scale (VAS) for the subjective perception of pain and compared with the results obtained before the intervention.
Timepoint [1] 307221 0
Immediately after the intervention
Secondary outcome [2] 307222 0
To assess the effectiveness of the stretching diaphragm technique in patients diagnosed of chronic low back pain by comparing results obtained Modified Schober test with those obtained before the intervention.
Timepoint [2] 307222 0
Immediately after the intervention.

Eligibility
Key inclusion criteria
Patients will be eligible for enrollment if they fulfill all of the following criteria:
- Patients with nonspecific mechanical low back pain during the year prior to study over 6 weeks duration or intermittent with at least 3 episodes, each lasting more than a week.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study for any of the following reasons:
- lumbar surgery.
- implantation of internal electrostimulation devices.
- having received osteopathic treatment in the last month.
- taken analgesic, anti-inflammatory medication or muscle relaxants in the last 72 hours before the study.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation was determined by the election of cards of colors. Each patient shuffled the cards and randomly picked one of them upside down. All cards were different. The red and green colors indicated that the patient would be part of the study group while the cards yellow and purple corresponded to the control group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/01/2014
Actual
10/01/2014
Date of last participant enrolment
Anticipated
Actual
10/02/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
53
Accrual to date
Final
Recruitment outside Australia
Country [1] 5881 0
Spain
State/province [1] 5881 0

Funding & Sponsors
Funding source category [1] 288860 0
Self funded/Unfunded
Name [1] 288860 0
Cleofas Rodriguez Blanco
Country [1] 288860 0
Spain
Primary sponsor type
Individual
Name
Prof. Dr. Cleofas Rodriguez Blanco
Address
C/ Avicena S/N. 41009. Seville. Spain.

Dpto. Department of Physiotherapy, University of Seville, Spain.
Country
Spain
Secondary sponsor category [1] 287556 0
Individual
Name [1] 287556 0
Beatriz Alvarez Lindo
Address [1] 287556 0
C/ Avicena S/N. 41009. Seville. Spain.

Dpto. Department of Physiotherapy, University of Seville, Spain.
Country [1] 287556 0
Spain

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The aim of study is to assess the effectiveness of the stretching diaphragm technique versus deep abdominal breathing in patients diagnosed of chronic low back pain; by comparing results obtained in the expiratory peak flow, distance finger-floor technique, Modified Schober test and the visual analogue scale (VAS) for the subjective perception of pain.

Materials and methods: Experimental, randomized, double-blind trial.
Nulle experimental hypothesis: The stretching diaphragm technique does not improve expiratory peak flow, finger-floor distance, Modified Schober test and the visual analogue scale (VAS) for the subjective perception of pain.
Mesures are going to be taken pre and post intervention by an independent trained and blinded evaluator. As materials, peak flow metter “pocket peak" for measuring the peak flow, VAS for the pain, and measuring-tape for the distance finger-floor and Modified Schober test will be used.
The final sample will consist of 53 patients diagnosed of chronic low back pain divided into two groups: An intervention group to whom diaphragm stretching technique will be applied and a control group to whom deep abdominal breathing exercises will be applied.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46454 0
Prof Cleofas Rodriguez Blanco
Address 46454 0
C/ Avicena S/N. 41009. Seville. Spain.
Department of Physiotherapy, University of Seville, Spain
Country 46454 0
Spain
Phone 46454 0
+34 954486510
Fax 46454 0
Email 46454 0
cleofas.rguez@gmail.com
Contact person for public queries
Name 46455 0
Prof M Dolores Cortes Vega
Address 46455 0
C/ Avicena S/N. 41009.Seville
Department of Physiotherapy, University of Seville, Spain
Country 46455 0
Spain
Phone 46455 0
+34 954486510
Fax 46455 0
Email 46455 0
marilocv@gmail.com
Contact person for scientific queries
Name 46456 0
Prof M Dolores Cortes Vega
Address 46456 0
C/ Avicena S/N. 41009.Seville
Department of Physiotherapy, University of Seville, Spain
Country 46456 0
Spain
Phone 46456 0
+34 954486510
Fax 46456 0
Email 46456 0
marilocv@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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