Focal Muscle Vibration on Flexibility and Perceived Stiffness in Patients With Mechanical Low Back Pain.
Primary Purpose
Mechanical Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventional therapy
vibration therapy
Sponsored by
About this trial
This is an interventional treatment trial for Mechanical Low Back Pain
Eligibility Criteria
Inclusion Criteria:
• Having mechanical low back pain from past 3 months
Exclusion Criteria:
- Patients with neurological symptoms
- Back operations 6 months before
- Leg length discrepancies
- Those diagnosed with bony deformity of spine like scoliosis and spondylolisthesis.
Sites / Locations
- Pakistan Railway General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional Therapy
Vibration Therapy
Arm Description
Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins).
Focal muscle vibrator (FMV) (120 Hz) for 10 minutes on paraspinal muscles. Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins).
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Numeric Pain Rating Scale:
General Information:
The patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours.
The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 hours.
• Patient Instructions (adopted from (McCaffery, Beebe et al. 1989):
"Please indicate the intensity of current, best, and worst pain levels over the past 24 hours on a scale of 0 (no pain) to 10 (worst pain imaginable)"
Full Information
NCT ID
NCT04760379
First Posted
February 16, 2021
Last Updated
May 10, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04760379
Brief Title
Focal Muscle Vibration on Flexibility and Perceived Stiffness in Patients With Mechanical Low Back Pain.
Official Title
Effect of Focal Muscle Vibration on Flexibility and Perceived Stiffness in Patients With Mechanical Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Evidence suggests that a period of localized muscle stimulation have positive effects on muscle function and in relieving pain and muscular stiffness.
In 2014 local muscle vibration frequency's acute effects on peak torque, EMG activity and rate of torque development was studied. The purpose of this study was to examine the effects of vibration on quadriceps muscle. Findings of this study suggest that local muscle vibration can encourage improvement in quadriceps activation and it can be useful in the treatment of quadriceps dysfunction that can occur in several knee pathologies.
A study was conducted in 2009 to examine the effects of vibration on arm muscles during isometric activity of muscles. Analysis according to the recordings revealed a significant increase in the waves on electromyography when vibration was applied. This study results revealed that vibration given to the specific muscles produces an increase of the activation and the coactivation.
A study in 1999 was held to investigate the effects of muscle vibration on the muscle spindles of Para spinal muscles in active lumbosacral position sense in sitting .This study suggest that muscle vibration technique was used to alter the potential afferent input from these Para spinal muscle receptors. Result shows that the muscle vibration on multifidus encouraged the illusion of significant muscle lengthening in the patients.
Another study in 2003 was held to inspect the facilitation of triceps brachii muscle contraction by applying the vibration on tendon after chronic cervical spinal cord injury. The efficacy of the vibration was checked by the analysis of a tonic vibration reflex was induced in each of the triceps brachii muscles at rest. If a reflex response was induced by the vibration before or during the voluntary contraction of the triceps brachii, vibration may facilitate the initiation, maintenance, and/or strength of the voluntary contraction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Therapy
Arm Type
Active Comparator
Arm Description
Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins).
Arm Title
Vibration Therapy
Arm Type
Experimental
Arm Description
Focal muscle vibrator (FMV) (120 Hz) for 10 minutes on paraspinal muscles. Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins).
Intervention Type
Other
Intervention Name(s)
Conventional therapy
Intervention Description
Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins).
Intervention Type
Other
Intervention Name(s)
vibration therapy
Intervention Description
Focal muscle vibrator (120 Hz) for 10 minutes on paraspinal muscles. Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins).
Primary Outcome Measure Information:
Title
Sit and Reach Test
Description
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
Time Frame
Change from baseline to 4 weeks
Title
Likert stiffness scale:
Description
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
Time Frame
Change from baseline to 4 weeks
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale:
Description
General Information:
The patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours.
The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 hours.
• Patient Instructions (adopted from (McCaffery, Beebe et al. 1989):
"Please indicate the intensity of current, best, and worst pain levels over the past 24 hours on a scale of 0 (no pain) to 10 (worst pain imaginable)"
Time Frame
Change from baseline to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Having mechanical low back pain from past 3 months
Exclusion Criteria:
Patients with neurological symptoms
Back operations 6 months before
Leg length discrepancies
Those diagnosed with bony deformity of spine like scoliosis and spondylolisthesis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anam Qureshi, MS-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Railway General Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
44000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24693945
Citation
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.
Results Reference
background
PubMed Identifier
21982256
Citation
Balague 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.
Results Reference
background
PubMed Identifier
25169762
Citation
Pamukoff 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.
Results Reference
background
PubMed Identifier
19204585
Citation
Mischi 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.
Results Reference
background
PubMed Identifier
10404575
Citation
Brumagne 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.
Results Reference
background
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Focal Muscle Vibration on Flexibility and Perceived Stiffness in Patients With Mechanical Low Back Pain.
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