Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001106527
Ethics application status
Approved
Date submitted
30/07/2024
Date registered
13/09/2024
Date last updated
13/09/2024
Date data sharing statement initially provided
13/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Flossband Combined Rehabilitation Therapy
in Treatment of Non-specific Chronic Lower Back Pain
Scientific title
Clinical and Biomechanical Parameters Change of 8 Weeks Flossband Combined Rehabilitation Therapy in the Treatment of Non-specific Chronic Lower Back Pain
Secondary ID [1] 311417 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-specific Chronic Lower Back Pain 334613 0
Condition category
Condition code
Musculoskeletal 331200 331200 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure


Each nonspecific chronic low back pain (NSCLBP) patient received one-on-one treatment, which included the following:
1. Myofascial Release (20 minutes): Targeted areas included the latissimus dorsi, spinal erectors, gluteal muscles, iliopsoas, and quadriceps.
2. Muscle Stretching Exercises (15 minutes): This included calf stretch, hamstring stretch, piriformis stretch, side lunges, hip complex stretch, side trunk stretch, cobra, and cat-cow stretch. Each stretch was held for 20 seconds and repeated for 1-3 sets.
3. Hip and Trunk Stability Exercises (20-30 minutes): Exercises included pelvic movements, hip adduction, clam, hip thrust, lateral sit-up, dead bug, bird dog, Swiss ball I Y W, calf raises, and farmer's walk, with 10-15 repetitions for 1-2 sets.
Flossband Treatment Groups:
• Flossband Group 1 (FG1): Received Flossband application (FA) with 30% stretch tension on the lumbar or lower limbs combined with Corrective Exercise Programs (CEP).
• Flossband Group 2 (FG2): Received FA on the same body parts without stretch tension, also combined with CEP.
• Control Group (CG): Conducted CEP without FA.
All groups underwent two treatment sessions per week for a total of six weeks. The Flossband was applied from the medial to lateral and proximal to distal directions, with each wrapping lasting 2-3 minutes.
Treatment Providers:
• All treatments were administered by a certified physiotherapist with five years of relevant experience and supervised by a senior certified physiotherapist with over 20 years of experience from the rehabilitation centre of the National Sports Institute of Malaysia.
• The exercise portion was guided by a licensed researcher specializing in corrective exercise from the National Academy of Sports Medicine (NASM) and supervised by a senior strength and conditioning coach certified by the National Strength and Conditioning Association (NSCA), with over 20 years of related experience, to ensure correct movement execution.
Additional Instructions:
• Each participant was instructed to maintain a training blog throughout the six-week intervention.
Intervention code [1] 329281 0
Rehabilitation
Intervention code [2] 329282 0
Treatment: Other
Comparator / control treatment
NSCLBP patients in the CG received 20 minutes of myofascial release, 15 minutes of muscle stretching exercises, and 20-30 minutes of hip and trunk stability exercises without applying the Flossband.
Control group
Active

Outcomes
Primary outcome [1] 338970 0
pain intensity
Timepoint [1] 338970 0
baseline, immediately post 1st session, after the 4th session treatment, after the 8th session treatment, and after the 12th session treatment
Primary outcome [2] 338971 0
Functional restoration parameters- lumbar flexion/extension
Timepoint [2] 338971 0
baseline, post immediately, after the 4th session treatment, after the 8th session treatment, and after the 12th session treatment
Primary outcome [3] 338972 0
Disability index
Timepoint [3] 338972 0
baseline, immediately post 1st session, after the 4th session treatment, after the 8th session treatment, and after the 12th session treatment
Secondary outcome [1] 438127 0
Thoracolumbar fascia thickness (TFLT)
Timepoint [1] 438127 0
baseline, immediately post 1st session, after the 4th session treatment, after the 8th session treatment, and after the 12th session treatment
Secondary outcome [2] 438128 0
Passive trunk extensor stiffness
(at 2.5 centimetres away the midpoint of L3 and L4 intervertebral space)
Timepoint [2] 438128 0
baseline, immediately post 1st session, after the 4th session treatment, after the 8th session treatment, and after the 12th session treatment
Secondary outcome [3] 438617 0
Functional restoration-gait spatiotemporal parameters
Timepoint [3] 438617 0
baseline, immediately post 1st session, after the 4th session treatment, after the 8th session treatment, and after the 12th session treatment
Secondary outcome [4] 438618 0
Functional restoration-Maximum isometric trunk extension strength
Timepoint [4] 438618 0
baseline, immediately post 1st session, after the 4th session treatment, after the 8th session treatment, and after the 12th session treatment
Secondary outcome [5] 438619 0
Trunk lateral flexion
Timepoint [5] 438619 0
baseline, immediately post 1st session, after the 4th session treatment, after the 8th session treatment, and after the 12th session treatment
Secondary outcome [6] 438620 0
Functional restoration-Trunk rotation
Timepoint [6] 438620 0
baseline, immediately post 1st session, after the 4th session treatment, after the 8th session treatment, and after the 12th session treatment
Secondary outcome [7] 438621 0
Functional restoration-straight leg raise (SLR)
Timepoint [7] 438621 0
baseline, immediately post 1st session, after the 4th session treatment, after the 8th session treatment, and after the 12th session treatment

Eligibility
Key inclusion criteria
The inclusion criteria were (1) Age between 20 and 60 years in both genders, (2) Recurrent back pain at least 12 weeks, (3) Local pain (pain in the area from T12 to gluteal folder) in current, (4) VAS from 2 to 8, (5) No radiating pain around the lower limb and buttocks, or neurological deficits, (6) No history of fracture or trauma on spine and lower limbs surgery, (7) No disk herniation or no spondylolysis, (8) Voluntarily signed the informed consent form, (9) completed twelve session treatments and five times measurements on time.
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria were as follows: (1) Pregnancy, (2) Severe spine scoliosis, (3) Manual therapy and exercise interventions focusing on the back within three months before the study, (4) Patients with cancer and tumour, (5) The other neurological and musculoskeletal diseases, (6) Use of anti-inflammatory drugs and analgesics in the two weeks before the intervention, (7) Attendance rate less than 80%, (8) Positive for COVID-19 cases.

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 phone/fax/compute
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (Random Number Generator (https://stattrek.com/statistics/random-number-generator.aspx).)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2022
Date of last participant enrolment
Anticipated
Actual
17/03/2023
Date of last data collection
Anticipated
Actual
30/04/2023
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 26484 0
Malaysia
State/province [1] 26484 0
Country [2] 26485 0
Malaysia
State/province [2] 26485 0

Funding & Sponsors
Funding source category [1] 315679 0
Government body
Name [1] 315679 0
the National Sports Institute of Malaysia (ISNRG No. 008/2021-009/2021)
Country [1] 315679 0
Malaysia
Primary sponsor type
University
Name
University Putra Malaysia
Address
Country
Malaysia
Secondary sponsor category [1] 319342 0
Government body
Name [1] 319342 0
the National Sports Institute of Malaysia
Address [1] 319342 0
Country [1] 319342 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314557 0
The National Sports Institute of Malaysia Research Ethics Committee
Ethics committee address [1] 314557 0
Ethics committee country [1] 314557 0
Malaysia
Date submitted for ethics approval [1] 314557 0
02/08/2021
Approval date [1] 314557 0
01/04/2022
Ethics approval number [1] 314557 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132002 0
Miss Jianhong Gao
Address 132002 0
Universiti Putra Malaysia, 43400 UPM Serdang, Selangor Darul Ehsan, Malaysia
Country 132002 0
China
Phone 132002 0
+61110730523
Fax 132002 0
Email 132002 0
[email protected]
Contact person for public queries
Name 132003 0
Thung Jin Seng
Address 132003 0
National Sports institute of Malaysia, 57000 Bukit Jalil, Kuala Lumpur, Malaysia
Country 132003 0
Malaysia
Phone 132003 0
+60122663031
Fax 132003 0
Email 132003 0
[email protected]
Contact person for scientific queries
Name 132004 0
Thung Jin Seng
Address 132004 0
National Sports institute of Malaysia, 57000 Bukit Jalil, Kuala Lumpur, Malaysia
Country 132004 0
Malaysia
Phone 132004 0
+60122663031
Fax 132004 0
Email 132004 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


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.