Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001364460
Ethics application status
Approved
Date submitted
15/08/2016
Date registered
30/09/2016
Date last updated
15/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Dynamic Neuromuscular Stabilization (DNS) for adults with chronic non-specific low back pain in activities of daily living
Scientific title
Effects of Dynamic Neuromuscular Stabilization (DNS) on lumbar motions of a specific task among adults with chronic non-specific low back pain
Secondary ID [1] 289844 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-specific chronic low back pain 299780 0
Condition category
Condition code
Musculoskeletal 299711 299711 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will be given standard physiotherapy care as described in the guideline for the control group with an added component of the DNS Approach with the guideline below. The choice of the standard physiotherapy care will be according to the discretion of the treating physiotherapist.
DNS Approach guideline.
The aim of the treatment is to achieve good intra-abdominal pressure and ribcage centration. This is observed as a cylindrical shape of abdominal region and non anteriorly flared ribcage. This intervention will be performed via verbal cues, manual guidance and visual feedback to correct the spine, ribcage, pelvic, scapula alignment and abdominal wall shape.
This intervention will be done in developmental kinesiology positions in relation to position of spine (Horizontal/vertical/angled).
*Operational definition of angled position is any position between horizontal and vertical)
*The actual developmental kinesiology position adopted during intervention for that day will vary according to the individuals' limitation of pain, weakness or tightness.

The physiotherapist will manually guide (verbally/visual feedback/ tactile facilitation) the participant to achieve ideal pattern of muscle activation in stabilising the body in the developmental kinesiology position adopted with the aim mentioned above (good IAP & ribcage centration)in the exercise. The component of body awareness to have adequate appropriate muscle relaxation is integrated according to DNS approach via participant's conscious awareness to the identified muscle area informed by the therapist during the DNS exercise.
This intervention will also be performed in a dynamic movement which resembles the ADL task being measured.
The participant will be given the home programme advise of the same DNS exercise done in the session.The home programme requires approximately 10-20 minutes per session of DNS home programme when self-done at home.
Each session will take approximately 40-45 minutes. In the case whereby the participant has aggravated pain, the standard physiotherapy care component will take approximately 30 minutes while the DNS component will take approximately 15 minutes. In the case whereby the pain is minimal, the standard physiotherapy care component will take approximately 15 minutes while the DNS component will take approximately 30 minutes.
Each physiotherapy treatment session will have the standard physiotherapy care and DNS component. Each participant will receive 8 physiotherapy sessions. The frequency of sessions are as follow:
2 sessions per week for 2 weeks(4 sessions)
1 session per week for 2 weeks(2 sessions)
1 session per 2 weeks in 1 month(2 sessions)
Each physiotherapy session is a one-to-one session at the physiotherapy department.
Each session is conducted by a physiotherapist who is a fully certified DNS Practitioner. Each participant will be treated by the same physiotherapist throughout the 8 sessions.
There are no strategies used to monitor adherence to intervention other than standard documentation of each session by the physiotherapist and subjective checking of adherence of participants to the advise given from the participants.
The DNS is received in addition to standard care.
Intervention code [1] 295527 0
Treatment: Other
Comparator / control treatment
Each session of the standard physiotherapy session is approximately 40-45 minutes.
Control group
Active

Outcomes
Primary outcome [1] 299164 0
1) Lumbar curvature.
Tool used is inertial sensors from the Xsens MTx(Xsens Technologies 2007)
Timepoint [1] 299164 0
Before and after (8 weeks)
Primary outcome [2] 299623 0
2)Lumbar kinematics.
Tool used is inertial sensors from the Xsens Mtx(Xsens Technologies 2007)
Timepoint [2] 299623 0
Before and after 8 weeks
Secondary outcome [1] 326390 0
Fear Avoidance Believe Questionnaire (FABQ)
Timepoint [1] 326390 0
Before and after (8 weeks)
Secondary outcome [2] 327705 0
Pain, assessed by VAS
Timepoint [2] 327705 0
Before and after 8 weeks

Eligibility
Key inclusion criteria
1. Diagnosed with chronic non-specific low back pain
2. Oswestry Low Back Pain Disability Index Questionnaire of 21%- 60%
3. VAS of pain above 0
4. Able to pick up a 500ml bottle of water from floor with dominant hand without increase VAS pain score (*Bottle is 1 foot in front of individual)
Minimum age
20 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Serious trauma leading to spinal vertebra fracture and dislocation prior to back surgery
2. Known rheumatological of joint inflammatory condition
3. Diagnosed to have spinal deformities such as scoliosis, ankylosing spondylitis, spondylolisthesis and spondylolisis.
4. Any known underlying pathologies such as tumour, spinal infections and tuberculosis.
5. Pregnancy or less than six months post-partum
6. Any neurological deficits.
7. Straight Leg Raise (SLR) test less than 70 degree on either leg (contra-lateral knee flexed)

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)
1) The participants will be assigned randomly using the Block Randomization method.
2) The possible treatment allocates are represented in 2 numbers. 1 represents the intervention group while 2 represents the control group.
3) Each number in each block is written on individual papers sheets where these number sheets will be arranged into the blocks.
4) These numbered papers are placed in opaque envelopes according to their blocks. These envelopes are all identical with no marks to identify what block it holds and the numbered papers are not visible from outside the envelopes.
5) Each time a participant qualifies to enter the research, the person (not the treating physiotherapists) will show all the opaque envelopes to the participant for the participant to pick randomly an envelope. Then the participant will take the 1st numbered sheet in the randomly chosen opaque envelope to be allocated to the treatment group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block Randomization.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
ANOVA: repeated measures, within-between interaction
The power analysis was calculated based on the G-power 3.1.5 (ANOVA).
Power analysis shows that this sample size would be sufficient to reveal significant differences between 2 groups of participants(Power = 0.80, p< 0.05).

Using SPSS 20, the descriptive data will be collected. The demographic data is obtained. Repeated measures of ANOVA will then be used to compare within and between subject effect.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/05/2016
Date of last participant enrolment
Anticipated
2/01/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment outside Australia
Country [1] 8076 0
Malaysia
State/province [1] 8076 0

Funding & Sponsors
Funding source category [1] 294222 0
University
Name [1] 294222 0
Universiti Kebangsaan Malaysia
Country [1] 294222 0
Malaysia
Primary sponsor type
University
Name
Universiti Kebangsaan Malaysia
Address
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz,
50300 Kuala Lumpur, MALAYSIA
Country
Malaysia
Secondary sponsor category [1] 293054 0
None
Name [1] 293054 0
Address [1] 293054 0
Country [1] 293054 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295687 0
Research Ethics Committee, The National University of Malaysia
Ethics committee address [1] 295687 0
Ethics committee country [1] 295687 0
Malaysia
Date submitted for ethics approval [1] 295687 0
Approval date [1] 295687 0
12/05/2016
Ethics approval number [1] 295687 0
UKM PPI/111/8/JEP-2016-229

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1006 1006 0 0
/AnzctrAttachments/371235-13. Ethic Approval.pdf

Contacts
Principal investigator
Name 67998 0
A/Prof Devinder Kaur Ajit Singh
Address 67998 0
Physiotherapy Programme
School of Rehabilitation Science,
Level 5, Bangunan Yayasan Selangor Kampung Baru,
Jalan Raja Muda Abdul Aziz,
Kampung Baru,
50300 Kuala Lumpur.
Country 67998 0
Malaysia
Phone 67998 0
+603-2687 8037
Fax 67998 0
Email 67998 0
[email protected]
Contact person for public queries
Name 67999 0
Lim Yi Lin
Address 67999 0
MyPhysio FiCoMo Specialist Centre,
12, Jalan 17/21,
Section 17,
46400 Petaling Jaya,
Selangor
Country 67999 0
Malaysia
Phone 67999 0
+6019-3687434
Fax 67999 0
Email 67999 0
[email protected]
Contact person for scientific queries
Name 68000 0
Lim Yi Lin
Address 68000 0
MyPhysio FiCoMo Specialist Centre,
12, Jalan 17/21,
Section 17,
46400 Petaling Jaya,
Selangor
Country 68000 0
Malaysia
Phone 68000 0
+6019-3687434
Fax 68000 0
Email 68000 0
[email protected]

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

Documents added manually
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