Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000074392
Ethics application status
Approved
Date submitted
5/11/2016
Date registered
13/01/2017
Date last updated
14/06/2019
Date data sharing statement initially provided
14/06/2019
Date results information initially provided
14/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Dry needling and exercise program in the treatment of patients with low back pain.
Scientific title
Effectiveness of dry needling and a specific exercise program in gluteus medius as treatment of patients with nonspecific mechanical low back pain.
Secondary ID [1] 290471 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonspecific mechanical low back pain 300838 0
Condition category
Condition code
Physical Medicine / Rehabilitation 300664 300664 0 0
Physiotherapy
Musculoskeletal 301032 301032 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the first session, in addition of all we´ve explained, the physiotherapy group will valorate the patients according to their kind of low back pattern. In next lines, we will explain the main characteristics of each kind of patron:

- Flexion:
-Pain during flexion-rotation activities, sedestation (like driving), and in semiflexion and complete flexion activities.
-In standing position: loss of low lumbar lordosis, muscular tone of high lumbar back and low dorsal back raised, "flatted ass", high lumbar lordosis, central surcus and prominence of spinal erectors and hip in extenction and external rotation.
-Flexion-relajation phenomenon: patients flex their back and then the erector relaxes
-Sedestation with no pain except when patients make brusquely rotation.
-During prolonged sedestation there is an increase in flexion of low back and pelvis retroversion
-During low back flexion, patients use just 1/2 of the movement of the hip and appearance of great low back kyphosis. They don´t reach the floor with their fingers.

-Active extenction
-Central pain due to prolonged low back extenction and positions of extenction and rotation
-Pain get worst with different activities: running, jumping, swimming and activities that require upper limbs above head
-In standing position: pelvis posterior to thorax, great low lumbar lordosis with central surcus, very curved ass, muscular tone of low back raised, pelvis anteversion (posterosuperior iliac spine above anterosuperior iliac spine) and loss of high lumbar lordosis
-Psoas and spinal erector very active
-Low protruding abdomen
-Hip flexors developed (anterior quadriceps rectum, iliac, tensor fasciae latae…) which generates anterior convexity in the thigh.
-Presence of dimples on sacrum skin
-Inability to maintain semiflexion posture (patients support this by putting their hands on their knees)

-Pasive extenction
-Pain for loss of motor control in extenction
-Passive tendency to extend low back
-Presence of pain in extenction position and during movement or activities in extenction position. Joint pain in activities prolonged in time
-In standing position: Thorax posterior to pelvis, pelvis in retroversión, presence of kyphosis in high lumbar back, collapsed posture.
-Low muscle tone
-Little hip control
Intervention code [1] 296323 0
Rehabilitation
Intervention code [2] 296608 0
Treatment: Other
Comparator / control treatment
the intervention in control group is the same than in the intervention group, except that, in the first session, instead of dry needling, physiotherapist will perform placebo dry needling by superficial dry needling (the patient will feel the prick but the needle won´t get to gluteus medium or any other muscle)
Control group
Placebo

Outcomes
Primary outcome [1] 300085 0
nonspecific low back mechanical pain, measured with 100 mm visual analogue scale.
Timepoint [1] 300085 0
It will be assessed before and after the dry needling procedure in the first session of the intervention, and 1 month, 3 months after the first session of intervention.
Secondary outcome [1] 328988 0
disability caused by nonspecific low back mechanical pain, measured with the Roland Morris Questionnaire.
Timepoint [1] 328988 0
It will be assessed before and after the dry needling procedure in the first session of the intervention, and 1 month, 3 months after the first session of intervention.

Eligibility
Key inclusion criteria
- Nonspecific low back mechanical pain
- Adults between 18 and 65 years old.
- Presence of nonspecific low back mechanical pain in the last year
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who underwent surgery in the lumbopelvic or hip región
- Patients who are following a physiotherapist treatment to solve their low back pain.
- Diabetic patients
- Pregnant patients
- Anticoagulated patients
- Patients with belenofobia

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 opaques envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Type of endpoint/s
Statistical methods / analysis
it was calculated 36 patients at least for participating in the study (18 per group), having in count the stadistic power of 0,95 and an alfa level of 0,05. It will be used the Gpower 3.0.18 software.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/11/2018
Actual
25/05/2017
Date of last participant enrolment
Anticipated
20/12/2018
Actual
26/09/2017
Date of last data collection
Anticipated
20/03/2019
Actual
21/12/2017
Sample size
Target
36
Accrual to date
Final
47
Recruitment outside Australia
Country [1] 8374 0
Spain
State/province [1] 8374 0
Comunidad de Madrid

Funding & Sponsors
Funding source category [1] 294885 0
University
Name [1] 294885 0
Universidad de Alcala
Country [1] 294885 0
Spain
Primary sponsor type
Individual
Name
Daniel Pecos Martin
Address
Facultad de Medicina y Ciencias de la Salud – Campus externo Universidad de Alcala, Carretera Madrid-Barcelona Km 33,600, Alcala de Henares (Madrid), Spain.
Country
Spain
Secondary sponsor category [1] 293722 0
None
Name [1] 293722 0
Address [1] 293722 0
Country [1] 293722 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296262 0
Comite de etica de la investigacion y de experimentacion animal de la Universidad de Alcala
Ethics committee address [1] 296262 0
Colegio de San Ildefonso, Plaza de San Diego s/n
28801, Alcala de Henares (Madrid)
Ethics committee country [1] 296262 0
Spain
Date submitted for ethics approval [1] 296262 0
19/09/2016
Approval date [1] 296262 0
26/09/2016
Ethics approval number [1] 296262 0
CEIM/HU/2016/14

Summary
Brief summary
The purpose of the study is to demonstrate that the treatment of the gluteus medius reduces nonspecific mechanical low back pain, specially if dry needling and an exercise program are performed instead of just exercise. We hypothesize that the weakness and the presence of trigger points is relationed directly with the low back pain of the patient, so the treatment focused on this muscle should reduce the low back pain level and also the disability.
Two randomized groups, of at least 18 patients with low back pain per group, will participate in the study. In the first session, the intervention group will be performed dry needling in gluteus medium, while the control group will be performed placebo dry needling. Both groups will learn an exercise program focused on gluteus medium which must perform for 8 weeks (2 days per week).
Outcomes have in count will be level of pain and disability, measured before the first session, after finishing the first session, and 1, 3 and 6 months after the first session.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1224 1224 0 0
/AnzctrAttachments/371782-Comite etica.pdf (Ethics approval)

Contacts
Principal investigator
Name 70186 0
Mr Jose Enrique Mendez Mera
Address 70186 0
C/Francisco del Pino n32, C.P. 28021 Madrid, Spain.
Country 70186 0
Spain
Phone 70186 0
+34677058261
Fax 70186 0
Email 70186 0
joseenriquemendezmera@gmail.com
Contact person for public queries
Name 70187 0
Mr Jose Enrique Mendez Mera
Address 70187 0
C/Francisco del Pino n32, C.P. 28021 Madrid, Spain.
Country 70187 0
Spain
Phone 70187 0
+34677058261
Fax 70187 0
-
Email 70187 0
joseenriquemendezmera@gmail.com
Contact person for scientific queries
Name 70188 0
Mr Jose Enrique Mendez Mera
Address 70188 0
C/Francisco del Pino n32, C.P. 28021 Madrid, Spain.
Country 70188 0
Spain
Phone 70188 0
+34677058261
Fax 70188 0
-
Email 70188 0
joseenriquemendezmera@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 371782-(Uploaded-14-06-2019-02-27-31)-Basic results summary.docx
Plain language summaryNo Significant improvements in both groups. Short ... [More Details]

Documents added automatically
No additional documents have been identified.