UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062338 |
|---|---|
| Receipt number | R000071335 |
| Scientific Title | Comparison of myofascial release using the Graston technique with and without resistance exercises on dynamic balance, fall risk, and chronic low back pain in elderly individuals over 65 years: a randomized controlled trial |
| Date of disclosure of the study information | 2026/07/30 |
| Last modified on | 2026/07/26 03:57:16 |
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Basic information
Public title
Comparison of myofascial release using the Graston technique with and without resistance exercises on dynamic balance, fall risk, and chronic low back pain in elderly individuals over 65 years: a randomized controlled trial
Acronym
Comparison of myofascial release using the Graston technique with and without resistance exercises on dynamic balance, fall risk, and chronic low back pain in elderly individuals over 65 years: a randomized controlled trial
Scientific Title
Comparison of myofascial release using the Graston technique with and without resistance exercises on dynamic balance, fall risk, and chronic low back pain in elderly individuals over 65 years: a randomized controlled trial
Scientific Title:Acronym
Comparison of myofascial release using the Graston technique with and without resistance exercises on dynamic balance, fall risk, and chronic low back pain in elderly individuals over 65 years: a randomized controlled trial
Region
| Asia(except Japan) |
Condition
Condition
PRE-POST
Classification by specialty
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the one-month durability of the interventions on dynamic balance, fall risk, and pain reduction following the completion of the treatment protocol.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
chronic low back pain intensity are assessed as the primary outcome variable. Chronic low back pain intensity is measured using the Visual Analog Scale.
Key secondary outcomes
Dynamic balance, fall risk. Dynamic balance and fall risk are measured using the Biodex Balance System, which provides an objective stability index for quantifying postural stability and the overall risk of falling.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Graston technique
Interventions/Control_2
Graston technique with Resistance exercises
Interventions/Control_3
Resistance exercises
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly individuals aged sixty years and older with chronic nonspecific low back pain lasting for at least three months are included. Participants must have a positive Noble test, indicating iliotibial band tightness, and a positive test, indicating gastrocnemius tightness. All participants must be willing and able to provide voluntary written informed consent prior to enrollment.
Key exclusion criteria
Individuals with Alzheimer's disease or severe dementia diagnosed by a physician are excluded. Those with uncontrolled hypertension or a history of spinal cord lesions are not eligible. Participants with severe visual impairment that may affect balance assessments are excluded. Individuals who have undergone surgery on the knee, hip, or ankle joints during the study period or who have sustained a lower extremity injury during the study period are excluded. Those receiving other structured exercise programs or physiotherapy during the study period are not eligible. Individuals who withdraw their consent or fail to attend more than two intervention sessions are excluded from the final analysis.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Minoo |
| Middle name | |
| Last name | Haghnevis |
Organization
shahid behshti university
Division name
SBU
Zip code
145782958
Address
TEHRAN
TEL
989336487376
shahramsamakosh92@gmail.com
Public contact
Name of contact person
| 1st name | Minoo |
| Middle name | |
| Last name | Haghnevis |
Organization
shahid behshti university
Division name
SBU
Zip code
145782958
Address
tehran
TEL
989336487376
Homepage URL
shahramsamakosh92@gmail.com
Sponsor or person
Institute
self funding
Institute
Department
Personal name
Funding Source
Organization
self
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
sbu
Address
TEHRAN
Tel
989336487376
shahramsamakosh92@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 26 | Day |
Last modified on
| 2026 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071335
