Mechanical Low Back PainNCT04760379
Focal Muscle Vibration on Flexibility and Perceived Stiffness in Patients With Mechanical Low Back Pain.
A study testing Conventional therapy and vibration therapy in people with Mechanical Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- Conventional therapy and vibration therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jan 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having mechanical low back pain from past 3 months
Who cannot join
- Patients with neurological symptoms
- Back operations 6 months before
- Leg length discrepancies
- Those diagnosed with bony deformity of spine like scoliosis and spondylolisthesis.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Railway General Hospital
Rawalpindi, Punjab Province, 44000
About this study
Official title: Effect of Focal Muscle Vibration on Flexibility and Perceived Stiffness in Patients With Mechanical Low Back Pain
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.
Read the 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.
- Conditions
- Mechanical Low Back Pain
- Being tested
- Conventional therapy, vibration therapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional therapyOther
Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins).
vibration therapyOther
Focal muscle vibrator (120 Hz) for 10 minutes on paraspinal muscles. Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins).
| Study group | Role | What they receive |
|---|---|---|
| Conventional Therapy | Active comparator | Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins). Receives: Other: Conventional therapy |
| Vibration Therapy | Experimental | 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). Receives: Other: vibration therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Change from baseline to 4 weeks
Secondary outcomes (1)
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)"
Measured: Change from baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start20 Jan 2021
- Primary completion30 Nov 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mechanical Low Back PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anam Qureshi, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760379
- Sponsor's protocol ID
- REC/00906 Maham Malik
- Status last verified
- May 2022
- First submitted
- 16 Feb 2021
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24693945Balague 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.
PubMed 21982256Pamukoff 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.
PubMed 25169762Mischi 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.
PubMed 19204585Brumagne 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.
PubMed 10404575
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Focal Muscle Vibration on Flexibility and Perceived Stiffness in Patients With Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT04760379
- Acronym / sponsor ID
- REC/00906 Maham Malik
- Conditions
- Mechanical Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy | Active comparator | Other: Conventional therapyBridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins). |
| Vibration Therapy | Experimental | Other: vibration therapyFocal muscle vibrator (FMV) (120 Hz) for 10 minutes on paraspinal muscles. Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins). |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Having mechanical low back pain from past 3 months
Key exclusion criteria (4 listed)
- Patients with neurological symptoms
- Back operations 6 months before
- Leg length discrepancies
- Those diagnosed with bony deformity of spine like scoliosis and spondylolisthesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional therapyBridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins). | Other | Conventional Therapy |
| vibration therapyFocal muscle vibrator (120 Hz) for 10 minutes on paraspinal muscles. Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins). | Other | Vibration Therapy |
Primary outcome
Sit and Reach Test
Time frame: Change from baseline to 4 weeks
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:
Time frame: Change from baseline to 4 weeks
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
1 secondary outcome
Numeric Pain Rating Scale:
Time frame: Change from baseline to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Background: PubMed 24693945Wang 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.
- Background: PubMed 21982256Balague 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.
- Background: PubMed 25169762Pamukoff 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.
- Background: PubMed 19204585Mischi 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.
- Background: PubMed 10404575Brumagne 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anam Qureshi, MS-OMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional therapy and vibration therapy in people with Mechanical Low Back Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sit and Reach Test (time frame: Change from baseline to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04760379, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.