Focal Muscle Vibration on Flexibility and Perceived Stiffness in Patients With Mechanical Low Back Pain.
Effect of Focal Muscle Vibration on Flexibility and Perceived Stiffness in Patients With Mechanical Low Back Pain
1 other identifier
interventional
44
1 country
1
Brief Summary
Low back pain that does not have any known specific pathology i.e.: tumor, any infection, fracture, osteoporosis, structural deformity, radicular syndrome, inflammatory disorder or cauda equine syndrome) is referred as non-specific low back pain.Over worldwide low back pain is a major public health challenge. Low back pain prevalence is shown to be 84% while 23% of chronic low back pain. Disability due to low back pain is about 11 to 12%. Low back pain is a leading cause of increasing economic burden in respect to huge medical expenses. Statistical analysis of indirect and direct expenses for the low back pain treatment in U.S shows over $100 billion per year.Many risk factors for low back pain has been identified including degeneration of lumbar discs, over weight/obesity, sedentary life style and mechanical factors i.e. occupational sitting, manual handling and assisting patients, awkward postures, lifting and carrying weights. Exercise therapy is suggested as an effective treatment in improving function of the back muscles and relieving pain in patients with Low back pain. Many studies suggested that muscle vibration is effective as the vibration signals are delivered via an external stimulator that is exposed to the part of the body resulting in pain relief and reducing muscle spasm. Vibratory stimuli have practical uses in rehabilitation and in exercise performance. Increasing reflexive activity through the stimulation of muscle spindles results in tonic vibratory reflex. The mechanical and electrical responses of the muscle could vary with the frequency of the vibration to the muscle. LMV effects are localized to the point where the stimulation is given and this is the result of neurogenic potentiation through the tonic vibratory reflex from the stimulation of muscle spindles. In our study we will work with 120hz frequency to improve the flexibility and perceived stiffness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2021
CompletedFirst Submitted
Initial submission to the registry
February 16, 2021
CompletedFirst Posted
Study publicly available on registry
February 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedMay 11, 2022
May 1, 2022
10 months
February 16, 2021
May 10, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Sit and Reach Test
The sit and reach test is the most common of all flexibility tests. It measures the flexibility of the clients' lower back and hamstrings. All you need is a box about 30cm high and a meter ruler. * Your client should sit on the floor with their back and head against a wall. Their legs should be out straight ahead and their knees flat against the floor. * Place the box against your client's feet (no shoes). Whilst keeping their head and back against the wall, instruct your client to stretch out their arms as far as they can towards the box without their head or back loosing contact with the wall. * Place the ruler on the box and move the zero end towards your clients fingertips. When the ruler touches their fingertips you have the zero point and the test can begin. * Instruct your client to lean forward slowly as far as possible keeping their fingertips level with each other and their legs flat on the floor. Their head and shoulders can come away from the wall now. * Slowly
Change from baseline to 4 weeks
Likert stiffness scale:
this is 7 points scale, o indicate a complete absence of soreness and 6 indicates a severe muscle soreness,stiffness and weakness that limits my ability to move
Change from baseline to 4 weeks
Secondary Outcomes (1)
Numeric Pain Rating Scale:
Change from baseline to 4 weeks
Study Arms (2)
Conventional Therapy
ACTIVE COMPARATORBridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins).
Vibration Therapy
EXPERIMENTALFocal muscle vibrator (FMV) (120 Hz) for 10 minutes on paraspinal muscles. Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins).
Interventions
Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins).
Focal muscle vibrator (120 Hz) for 10 minutes on paraspinal muscles. Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins).
Eligibility Criteria
You may qualify if:
- Having mechanical low back pain from past 3 months
You may not qualify if:
- Patients with neurological symptoms
- Back operations 6 months before
- Leg length discrepancies
- Those diagnosed with bony deformity of spine like scoliosis and spondylolisthesis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pakistan Railway General Hospital
Rawalpindi, Punjab Province, 44000, Pakistan
Related Publications (5)
Wang XQ, Pi YL, Chen PJ, Chen BL, Liang LC, Li X, Wang X, Zhang J. Whole body vibration exercise for chronic low back pain: study protocol for a single-blind randomized controlled trial. Trials. 2014 Apr 2;15:104. doi: 10.1186/1745-6215-15-104.
PMID: 24693945BACKGROUNDBalague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
PMID: 21982256BACKGROUNDPamukoff DN, Ryan ED, Blackburn JT. The acute effects of local muscle vibration frequency on peak torque, rate of torque development, and EMG activity. J Electromyogr Kinesiol. 2014 Dec;24(6):888-94. doi: 10.1016/j.jelekin.2014.07.014. Epub 2014 Aug 7.
PMID: 25169762BACKGROUNDMischi M, Cardinale M. The effects of a 28-Hz vibration on arm muscle activity during isometric exercise. Med Sci Sports Exerc. 2009 Mar;41(3):645-53. doi: 10.1249/MSS.0b013e31818a8a69.
PMID: 19204585BACKGROUNDBrumagne S, Lysens R, Swinnen S, Verschueren S. Effect of paraspinal muscle vibration on position sense of the lumbosacral spine. Spine (Phila Pa 1976). 1999 Jul 1;24(13):1328-31. doi: 10.1097/00007632-199907010-00010.
PMID: 10404575BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anam Qureshi, MS-OMPT
Riphah International University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2021
First Posted
February 18, 2021
Study Start
January 20, 2021
Primary Completion
November 30, 2021
Study Completion
December 30, 2021
Last Updated
May 11, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share