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Trial registered on ANZCTR


Registration number
ACTRN12616001236482
Ethics application status
Approved
Date submitted
6/08/2016
Date registered
6/09/2016
Date last updated
7/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of manual therapy and neuromuscular bandage in the treatment of mechanical low back pain
Scientific title
The effectiveness of manual therapy and neuromuscular bandage in the treatment of mechanical low back pain
Secondary ID [1] 289870 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 299819 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299741 299741 0 0
Physiotherapy
Musculoskeletal 299839 299839 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatments will be carry out during 2 sessions a week/ 3 weeks and there will be 1 check-up 1 month after the last session (total duration of the study: 7 weeks). To develop this study 2 professional will be needed (both professionals are physiotherapists):
- The first professional (P1) will do the selection the sample and the evaluation.
- The second professional (P2) will do the randomisation into 2 groups and the treatment.

The treatments will be:
Each patient will be randomly assigned one of two treatments. Both groups will receive the same Manual Therapy Program by the second professional (physiotherapist with more than 5 years experience).

The Manual Therapy Program has duration of 30 minutes.
- Passive mobilizations: 2 sets of 10 flexion mobilizations, 10 extensions, 10 abductions, 10 adductions, 10 internal rotations and 10 external rotations.
- Massage with movement: massage at muscles of low back pain from craneal to caudal while the patient makes an active anterior flexion (3 times).
- Passive stretching: physiotherapist takes both patient´s legs and she does a flexion in order to approximate the knees of the patient to his breast (3 times of 1 minute).
- Pressure release: at myofascial trigger points of quadratus lumborum (3 cycles each point with a maximum of three).

Active exercises: patient lies in a pad with knees´s flexion. 10minutes.
- Patients make little steps from right to left (lateroflexion). 1 set of 10 times.
- Patients drop his legs to both sides (rotation). 1 set of 10 times.
Active exercises: patient in cuadrupedia.5 minutes.
- Cat-horse: take the whole column to flexion and extension respectively. 1 set of 10 times.

All exercises have a comfortable intensity without pain, just muscular tension.
The difference between groups will be that one of them will additionally receive a neuromuscular bandage at the end of the session (after the treatment and the exercises).
.
Neuromuscular bandage will be placed by a physiotherapist at paraspinal low back muscles: 2 vertical strips without tension and one transversal strip with 50% of tension. Patients have to make an active anterior flexion to place it and thy have to keep it during 4 days.
Intervention code [1] 295554 0
Rehabilitation
Intervention code [2] 295640 0
Treatment: Other
Comparator / control treatment
Control group will have the same Manual Therapy Program but they will receive a false neuromuscular bandage.

This tape bandage haven´t the properties of the neuromuscular bandage, It is not elastic and his application has no tension. On the other hand .the strips have the same place in both groups.
Control group
Placebo

Outcomes
Primary outcome [1] 299199 0
Pain will be assessed with a numeric pain scale.
Timepoint [1] 299199 0
Pain will be taken at baseline (before the first treatment), at the end of each session (2 session a week/3 weeks) and a month after the last session.
Primary outcome [2] 299200 0
Range of motion will be assessed with a goniometer.
Timepoint [2] 299200 0
Range of motion will be taken at baseline (before the first treatment), at the end of each session (2 session a week/ 3 weeks) and a month after the last session.
Secondary outcome [1] 326487 0
Function will be assessed with an Oswestry questionnaire.
Timepoint [1] 326487 0
Function will be taken at baseline, at the sixth session and a month after the last session.

Eligibility
Key inclusion criteria
1. Age from 18 to 67 years old.
2. Having low back pain at the beginning of the study with a minimum duration of 7 days.
Minimum age
18 Years
Maximum age
67 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pain associated to a traumatism.
2. Specific pathology like hernia, protrusion…
3. Pharmacological treatment.
4. Neurological process in low back.
5. Osteosynthesis in the area.
6. Being pregnant.

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)
Central randomisation by computer (Epidat).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by 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
Statistical methods / analysis
Since no previous studies that allowed us to determine the sample size of the study, a pilot study with 11 patients in each group was performed. We used the mean and standard deviation of the primary outcome (improvement in pain) in the control group , the average was 6,636 (1,566 DT) and at the case group was 8 (DT 1,183) . Under these conditions the effect size or standardized mean difference (Cohen's d) was equal to 1.03038. We used Gpower program and we considered an alpha error of 0.05 and 80% of power, the sample size required was 26 subjects (13 in each group) .

The statistical tests we have chosen are:

A Friedman test and a Dunn test: to see the difference between the initial and final average of each variable in the same group.
A t-student test for independent samples: to see the difference between the initial and final average of each variable between groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/10/2016
Actual
3/10/2016
Date of last participant enrolment
Anticipated
28/10/2016
Actual
3/10/2016
Date of last data collection
Anticipated
23/12/2016
Actual
21/11/2016
Sample size
Target
26
Accrual to date
Final
28
Recruitment outside Australia
Country [1] 8081 0
Spain
State/province [1] 8081 0
Salamanca

Funding & Sponsors
Funding source category [1] 294245 0
University
Name [1] 294245 0
University of Salamanca
Country [1] 294245 0
Spain
Primary sponsor type
University
Name
University of Salamanca
Address
Avda. Donante de sangre s/n. 37007 Salamanca
Country
Spain
Secondary sponsor category [1] 293079 0
University
Name [1] 293079 0
University of Alcala
Address [1] 293079 0
Campus Cientifico-Tecnologico: Crta. de Madrid-Barcelona, Km. 33,600. Alcala de Henares
Country [1] 293079 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295668 0
CEIC del Area de Salud de Salamanca (Hospital Clínico Universitario
Ethics committee address [1] 295668 0
Paseo San Vicente, 58-182, CP: 37007
Ethics committee country [1] 295668 0
Date submitted for ethics approval [1] 295668 0
29/04/2011
Approval date [1] 295668 0
23/05/2011
Ethics approval number [1] 295668 0

Summary
Brief summary
Nowadays, low back pain is considered as the first limitation of the activity in people younger than 45 years and the most prevalent muscular pathology in people older than 65 years old. In the same way low back pain, is the second reason of medical consultations, the third of surgery and the fifth of hospital admission.
There are a lot of treatments which try to prove its effectiveness in this type of pathology without significative results or conclusions in relation of which treatment is the most effective.
In last years, the neuromuscular bandage or kynesiotape has been widely used all around the world for the treatment of muscular disorders.
This neuromuscular bandage or kynesiotape was discovered by Kenzo Kase and Murai in the seventies. They established the functions of this bandage:
- Analgesia.
- Improvement of muscular function.
- Correction of articular position and the movement direction.
- Stimulation of propioception.
- Increasing stability.

Besides, this pain is an important problem because of sick leave reductions so it´s necessary an effective treatment for this patients. No studies have been found a treatment with long effects for this matter yet. That is the reason we introduce this study. We hope the addition of kynesiotape to the conservative treatment carries analgesic effects, improves movement, function, reduces pain and of course makes possible people return work.

HYPOTHESIS:
- Conceptual hypothesis: Kynesiotape is effective in mechanical low back pain after the conservative treatment of physiotherapy.
- Operative hypothesis: Kynesiotape after the conservative treatment of physiotherapy, comparing with the control group, reduces pain at 3 points of VAS.

OBJECTIVES:
- Main objective: Checking if kynesiotape is an effective complement in the conservative treatment of mechanical low back pain.
- Secondary objective: Improve range of motion, pain and function, just as make people return work reducing absenteeism from work.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67974 0
Dr Ines Llamas-Ramos
Address 67974 0
University School of Nursing and Physiotherapy. Univerisity of Salamanca
Avda. Donante de sangre s/n. 37007 Salamanca
Country 67974 0
Spain
Phone 67974 0
+34 630720990
Fax 67974 0
Email 67974 0
[email protected]
Contact person for public queries
Name 67975 0
Dr Ines Llamas-Ramos
Address 67975 0
University School of Nursing and Physiotherapy. Univerisity of Salamanca
Avda. Donante de sangre s/n. 37007 Salamanca
Country 67975 0
Spain
Phone 67975 0
+34 630720990
Fax 67975 0
Email 67975 0
[email protected]
Contact person for scientific queries
Name 67976 0
Dr Ines Llamas-Ramos
Address 67976 0
University School of Nursing and Physiotherapy. Univerisity of Salamanca
Avda. Donante de sangre s/n. 37007 Salamanca
Country 67976 0
Spain
Phone 67976 0
+34 630720990
Fax 67976 0
Email 67976 0
[email protected]

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