NCT04760379

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

February 16, 2021

Last Update Submit

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 COMPARATOR

Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins).

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).

Other: vibration therapy

Interventions

Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins).

Conventional Therapy

Focal muscle vibrator (120 Hz) for 10 minutes on paraspinal muscles. Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins).

Vibration Therapy

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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: 24693945BACKGROUND
  • 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.

    PMID: 21982256BACKGROUND
  • 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.

    PMID: 25169762BACKGROUND
  • 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.

    PMID: 19204585BACKGROUND
  • 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.

    PMID: 10404575BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anam Qureshi, MS-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

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

Locations